FDA CATEGORIES  torna a risorse mediche

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Nortriptyline
Tricyclic antidepressant. Nortriptyline is a metabolite of amitriptyline.
CATEGORY: "Safe use of nortriptyline during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards"[G6].
BREAST FEEDING: The American Academy of Pediatrics has classified nortriptyline as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3]. The WHO Working Group on Human Lactation estimated that 2% of the maternal daily dose would be ingested by a breast feeding infant, and concluded that breastfeeding while taking this medication is probably safe.[G8].
NEONATAL SIDE EFFECTS: Possible urinary retention [1].

CERCA LETTERATURA

1.Shearer WT et al.: Urinary retention in a neonate secondary to maternal ingestion of nortriptyline. J Pediatr 81:570-2, 1972. MEDLINE


NSAID
CATEGORY:B or C in early pregnancy depending on compound.
CATEGORY:D near term .

NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a common complication with NSAIDs as a class.
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Nystatin, vaginal tablet
Antifungal
CATEGORY: C
BREAST FEEDING: Compatible.[G1].
NEONATAL SIDE EFFECTS: None reported.

CERCA LETTERATURA


Ofloxacin
Anti-infective;Quinolone
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified ofloxacin as a drug "Usually Compatible With Breastfeeding" [G3]. However, Briggs GG et al. do not consider this drug compatible with breast feeding, because of high excretion of this drug into human milk [G1].
NEONATAL SIDE EFFECTS: None reported.

CERCA LETTERATURA


Olanzapine
Antipsychotic. Monoaminergic antagonist
23 olanzapine-exposed pregnancies resulted in no increase in major or minor anomalies. However, the sample size is too small to draw firm conclusions [1].
CATEGORY:C
BREAST FEEDING: The manufacturer does not consider this drug to be compatible with breast feeding.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1.Goldstein DJ, Corbin LA, Fung MC. Olanzapine-exposed pregnancies and lactation: early experience. J Clin Psychopharmacol. 2000 Aug;20(4):399-403. MEDLINE


Olsalazine
Anti-inflammatory agent for gastrointestinal use. Olsalazine is converted to mesalamine (5-aminosalicylic acid) in the colon.
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified 5-aminosalicylic acid as a drug that "should be given to nursing mothers with caution" [G3].
NEONATAL SIDE EFFECTS: May cause diarrhea.

CERCA LETTERATURA


Omeprazole
Proton Pump Inhibitor. Used for control of stomach acid
CATEGORY:C
Although there are a number of case reports of fetal anomalies (anencephaly, hydranencephaly, and talipes) following the use of omeprazole [G1] large human studies have not supported an association between omeprazole and congenital defects[1-4].
BREAST FEEDING: A single case report suggests that there is minimal excretion of omeprazole into human breast milk [5]. Because of the limited data regarding the potential for serious adverse reactions in nursing infants from omeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Lalkin A, Loebstein R, Addis A, Ramezani-Namin F, Mastroiacovo P, Mazzone T, Vial T, Bonati M, Koren G. The safety of omeprazole during pregnancy: A multicenter prospective controlled study. Am J Obstet Gynecol 1998;179:727-30. MEDLINE
2. Kallen B: Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole. Br J Obstet Gynaecol 105:877-881, 1998. MEDLINE
3.Ruigomez A, Garcia Rodriguez LA, Cattaruzzi C, Troncon MG, Agostinis L, Wallander MA, Johansson S. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 150:476-481, 1999. MEDLINE
4.Kallen BA. Use of omeprazole during pregnancy--no hazard demonstrated in 955 infants exposed during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2001 May;96(1):63-8. MEDLINE
5. Marshall JK, Thompson AB, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation.Can J Gastroenterol. 1998 Apr;12(3):225-7. MEDLINE


Ondansetron

Ondansetron (Zofran® tablets and injection)
Antiemetic. Selective 5-HT 3 receptor antagonist .
Molecular weight: 365.9. Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, with binding constant over the pharmacologic concentration range (10 to 500 ng/mL).
CATEGORY:B

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15  and 30 mg/kg per day respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron [1].

Reports on the use of ondansetron during the first trimester in human pregnancy are scarce.

In one case report ondansetron 8 mg IV TID was used to successfully treat hyperemesis gravidarum in a woman from approximately 11 to 13 weeks gestation. She gave birth to a term healthy infant [2].  Tincello and Johnstone also used ondansetron intermittently every trimester to  treat hyperemesis gravidarum in one patient with no apparent adverse effects on the mother or infant [3].

In a randomized controlled trial comparing ondansetron with promethazine for the treatment of hyperemesis gravidarum 15 patients were treated with ondansetron at a mean gestational age of 11 weeks'. Patients were given an initial dose of ondansetron 10 mg IV with additional doses as need TID. Ondansetron demonstrated no benefit over promethazine in patients hospitalized for hyperemesis gravidarum. The authors of the study suggested that increasing ondansetron dosages or using a continuous infusion might have improved the treatment response. Pregnancy outcomes were not reported for either group [4].

In two additional case reports of pregnant women treated with ondansetron during the third trimester both mothers delivered normal infants [5, 6].

While the above reports are reassuring the number of reported cases is too small to draw firm conclusions regarding the teratogenic risk of ondansetron in human pregnancy.

BREAST FEEDING: It is not known whether ondansetron is excreted into human milk.


SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 1680-2
2. Guikontes E, et al. Ondansetron and hyperemesis gravidarum.Lancet. 1992; 340: 1223.  MEDLINE
3. Tincello DG and  Johnstone MJ.Treatment of hyperemesis gravidarum with the 5-HT3 antagonist ondansetron (Zofran).Postgrad Med J. 1996;72:688-9. MEDLINE
4. Sullivan CA, et al. A pilot study of intravenous ondansetron for hyperemesis gravidarum. Am J Obstet Gynecol. 1996 ; 174: 1565-8.MEDLINE
5. World MJ: Ondansetron and hyperemesis gravidarum.Lancet. 1993; 341: 185. MEDLINE
6. Arango HA, et al. Management of chemotherapy in a pregnancy complicated by a large neuroblastoma.Obstet Gynecol. 1994 ;84:665-8. MEDLINE

 


Oxacillin
Antibiotic, Penicillin
CATEGORY:B
First trimester exposure to penicillin derivatives in more than 3500 human pregnancies was not associated with an increased risk of congenital anomalies [G1]. The findings of a more recent small study did not find an increased risk of congenital anomaly after exposure to oxacillin during pregnancy [1].
BREAST FEEDING: Excreted into human breast milk.
NEONATAL SIDE EFFECTS: Possible diarrhea.

CERCA LETTERATURA

1.Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J.Teratogenic evaluation of oxacillin. Scand J Infect Dis. 1999;31(3):311-2. MEDLINE


Oxaprozin
Nonsteroidal Anti-Inflammatory
CATEGORY:C
NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a common complication with NSAIDs as a class.
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Oxazepam
Anxiolytic. Metabolite of diazepam, prazepam and temazepam
CATEGORY:D
BREAST FEEDING: The WHO Working Group on Drugs and Human Lactation considers oxazepam compatible with breast feeding when taken by mothers in occasional small doses .[G8].
NEONATAL SIDE EFFECTS: Possible sedation and depression.

CERCA LETTERATURA

ADDITIONAL READING: Benzodiazepines in Pregnancy
1999 Illinois Teratogen Information Service


Oxycodone
Opioid analgesic. Molecular weight: 351.83
CATEGORY:B

"Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg and 125 mg/kg, respectively. These doses are 3 and 46 times a human dose of 160 mg/day, based on mg/kg basis. The results did not reveal evidence of harm to the fetus due to oxycodone." [1]

Results of The Collaborative Perinatal Project found no increase in the incidence of major malformations among 8 pregnancies exposed during the first trimester to oxycodone [2].

Schick et. al. also found no significant increase in the incidence of major malformations  in 78 pregnancies after first trimester exposure to oxycodone [3].

Briggs et. al. reported that data from a surveillance study of Michigan Medicaid recipients did not support an association between oxycodone and major malformations in 281 newborns who had been exposed to oxycodone during the first trimester [4].

BREAST FEEDING: Oxycodone is excreted into breast milk [5, 6]. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone [1].

NEONATAL SIDE EFFECTS: Drowsiness and withdrawal symptoms in the neonate [7].

SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 2856-57
2 Heinonen OP, Slone D, Shapiro S: Birth Defects and Drugs in Pregnancy. Publishing Sciences Group Inc., Littleton, MA, 1977.p 287
3. Schick B, et al. Preliminary analysis of first trimester exposure to oxycodone and hydrocodone.[Abstract] Reprod Toxicol. 1996;10:162.
4. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1053-1054
5. Marx CM, et al. Oxycodone excretion in human milk in the puerperium. [Abstract] Drug Intell Clin Pharm 1986;20:474.
6. Dickson PH, et al.The routine analysis of breast milk for drugs of abuse in a clinical toxicology laboratory.J Forensic Sci. 1994 Jan;39(1):207-14. PMID: MEDLINE
7.Rao R and Desai NS OxyContin and neonatal abstinence syndrome. J Perinatol. 2002 Jun;22(4):324-5. PMID: MEDLINE

 


Paromomycin
Antibiotic, Aminoglycoside.Used in the treatment of intestinal parasites.
CATEGORY:C
In the absence of intestinal ulceration paromomycin is poorly absorbed [1].
BREAST FEEDING: Compatible with breast feeding. Because this drug is poorly absorbed orally high concentrations in breast milk would not be expected [G1].
NEONATAL SIDE EFFECTS: None reported.

CERCA LETTERATURA

1. Gardner TB, Hill DR.Treatment of giardiasis. Clin Microbiol Rev. 2001 Jan;14(1):114-28. Review. MEDLINE


Paroxetine
Antidepressant
CATEGORY:C
Limited human data suggests no increased rate of anomaly. However, there is insufficient data on possible behavioral teratogenic effects .
BREAST FEEDING: Excreted into breast milk. Compatible [1]. The American Academy of Pediatrics has classified paroxetine as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS: Neonatal withdrawal syndrome has been reported after third trimester in utero exposure [2] .

CERCA LETTERATURA

1. Begg EJ, Duffull SB, Saunders DA, Buttimore RC, Ilett KF, Hackett LP, Yapp P, Wilson DA. Paroxetine in human milk. Br J Clin Pharmacol. 1999 Aug;48(2):142-7. MEDLINE
2. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr. 2001 Mar;90(3):288-91. MEDLINE

ADDITIONAL READING: Paxil (PDF file)
2000 Organization of Teratology Information Services


Penicillamine
CATEGORY:D
BREAST FEEDING: Contraindicated [1,2]
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Ostensen M. Treatment with immunosuppressive and disease modifying drugs during pregnancy and lactation. Am J Reprod Immunol. 1992 ;28:148-52.MEDLINE
2. Copper disposition of the fetus and placenta in a patient with untreated Wilson's disease.
Am J Obstet Gynecol. 1993;169:196-8.MEDLINE


Penicillin
CATEGORY:B
BREAST FEEDING: Compatible [1]
NEONATAL SIDE EFFECTS: Rash, diarrhea

CERCA LETTERATURA

1. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy Perinatol. 1984;5(2):57-60.MEDLINE


Pentazocine
CATEGORY: C, D*
BREAST FEEDING: It is not known whether this drug is excreted in human milk.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

*All narcotics may produce withdrawal syndrome in neonates with prolonged use.


Permethrin
Scabicide, topical
CATEGORY:B
BREAST FEEDING: Compatible [1]
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the Study of Venereal Disease). National guidelines for the management of scabies. Sex Transm Inf 1999;75:S76-7 (PDF file)


Phenobarbital
CATEGORY:D
BREAST FEEDING:The American Academy of Pediatrics has classified phenobarbital as a drug that has been associated with significant effects on some nursing infants and should be given to nursing mother with caution.[G3].
NEONATAL SIDE EFFECTS: Sedation, rash, withdrawal, methemoglobinemia [G3]

CERCA LETTERATURA


Phenothiazines
CATEGORY:C
BREAST FEEDING: See individual agents.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Phentermine
Sympathomimetic amine chemically related to amphetamine. Used as appetite suppressant.
CATEGORY:C. Safe use in human pregnancy has not been established. However, a small controlled prospective cohort study of 98 pregnancies found no increased risk of spontaneous pregnancy loss, or of major or minor anomalies after first trimester exposure to the combination phentermine/fenfluramine [1].
BREAST FEEDING: It is not known whether phentermine is excreted into human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Jones KL, Johnson KA, Dick LM, Felix RJ, Kao KK, Chambers CD.Pregnancy outcomes after first trimester exposure to phentermine/fenfluramine. Teratology. 2002;65:125-30. MEDLINE

ADDITIONAL READING: Phentermine(PDF file)
2000 Organization of Teratology Information Services


Phenylpropanolamine
The FDA has requested that all drug companies discontinue marketing products containing phenylpropanolamine, because of an association between phenylpropanolamine and an increased risk of hemorrhagic stroke in women.

First trimester exposure has been associated with a statistically significant increased rate of eye and ear malformations [G10].
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

ADDITIONAL READING: Over the Counter Cold Medications in Pregnancy
1998 Illinois Teratogen Information Service


Phenytoin
Anticonvulsant
CATEGORY:D
Fetal Hydantoin Syndrome: Cardiac defects, dysmorphic craniofacial features, hypoplastic nails, and distal phalanges, intrauterine growth restriction, and microcephaly. Mental retardation may be seen when the full syndrome is present.
Up to 30% of exposed fetuses may have anomalies; The full syndrome occurs in 10% of exposed fetuses [1]. Fetuses with low activity of the enzyme microsomal epoxide hydrolase appear to be at highest risk for developing the syndrome. [2].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Rare methemoglobinuria

CERCA LETTERATURA

1.Teratology. ACOG technical bulletin number 236--April 1997
2. Buehler BA et al.,Prenatal prediction of risk of the fetal hydantoin syndrome. N Engl J Med 322:1567, 1990 MEDLINE


Pindolol
Hypotensive agent, beta-adrenergic blocking agent
CATEGORY:B
BREAST FEEDING: The manufacturer does not consider pindolol to be compatible with breast feeding.
NEONATAL SIDE EFFECTS: Possible hypotension, bradycardia

CERCA LETTERATURA


Piroxicam
Nonsteroidal Anti-Inflammatory
CATEGORY:C
NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a complication with NSAIDs as a class.
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Potassium
CATEGORY: C
BREAST FEEDING: Compatible [G1].  
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Potassium Iodide
Expectorant
CATEGORY:D
Crosses placenta. Prolonged use may cause hypothyroidism in the fetus.
BREAST FEEDING: Compatible [G9].
NEONATAL SIDE EFFECTS: Goiter, allergic reactions

CERCA LETTERATURA


Pravastatin
Antilipemic Agent, HMG-CoA reductase inhibitor
CATEGORY:X
BREAST FEEDING: Contraindicated [G1].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Prednisone
Corticosteroid
CATEGORY:" The use of these drugs (corticosteroids) in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus."[G6]. Many older studies including a surveillance study of Michigan Medicaid recipients do not support an association between prenatal prednisone exposure and congenital anomalies[G1]. However, more recent studies suggest a possible increased risk of oral cleft when prednisone is used during the first trimester in humans [1,2].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

CERCA LETTERATURA

1. Carmichael SL; Shaw GM: Maternal corticosteroid use and risk of selected congenital anomalies. Am J Med Genet 1999;86:242-4. MEDLINE
2.Park-Wyllie L, Mazzotta P, Pastuszak A, Moretti ME, Beique L, Hunnisett L, Friesen MH, Jacobson S, Kasapinovic S, Chang D, Diav-Citrin O, Chitayat D, Nulman I, Einarson TR, Koren G. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratology. 2000 Dec;62(6):385-92. MEDLINE

ADDITIONAL READING: Corticosteroids in Pregnancy
2000 Illinois Teratogen Information Service


Premarin (Conjugated estrogen)
CATEGORY:X
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Primidone
Anticonvulsant
CATEGORY:D
BREAST FEEDING: The American Academy of Pediatrics has classified primidone as a drug that has been associated with significant effects on some nursing infants and should be given to nursing mother with caution.[G9].
NEONATAL SIDE EFFECTS: Sedation.

CERCA LETTERATURA


Procainamide
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G9].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Prochlorperazine
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS: Possible sedation.

CERCA LETTERATURA


Progesterone
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Promethazine
CATEGORY:C
BREAST FEEDING: With caution
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Propanolol
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hypotension,bradycardia

CERCA LETTERATURA


Propoxyphene
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Withdrawal

CERCA LETTERATURA


Propylthiouracil
CATEGORY:D
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Potential for hypothyroidism

CERCA LETTERATURA


Pseudoephedrine
Sympathomimetic agent used as a decongestant (vasoconstrictor). Molecular weight:201.70
CATEGORY: C

A retrospective study by Werler MM,  et al. , found that among mothers of 206 infants with gastroschisis and 126 mothers of infants with small intestinal atresia infants with gastroschisis had an increased risk (odds ratio = 1.8) of having been exposed to pseudoephedrine during gestation. The risk for gastroschisis was increased further (odds ratio = 4.2) among infants who had been exposed to pseudoephedrine combined with acetaminophen. The risk of small intestinal atresia was also increased for any use of pseudoephedrine (odds ratio = 2.0) and for use of pseudoephedrine in combination with acetaminophen (odds ratio = 3.0). The authors of the study cautioned that underlying maternal illness may have confounded the results of this study [1].

Gastroschisis is a congenital defect of the anterior abdominal wall characterized by an opening beside the umbilical cord that allows bowel to protrude. Gastroschisis is thought to arise from disruption of blood flow  to the affected abdominal wall [2]. The defect is uncommon and occurs in the general population with an incidence of  2.4 to 3.2 per 10,000 births in the general population with the highest incidence in women 15-19 years of age ( 26.5 per 10,000 births) [3,4]. The uncommon occurrence of gastroschisis should  be considered when counseling patients or interpreting the literature as to the increased risk for gastroschisis after any particular drug ingestion.

In contrast to the above epidemiological study by Werler MM, et al. three retrospective studies of 1,842 newborns exposed to pseudoephedrine during the first trimester found no increased risk for malformations [5-7]. In addition a prospective study by Schatz et al. also found no increased risk for malformations in 714 infants after exposure to pseudoephedrine at any time during pregnancy[8].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) recommend oral decongestants be avoided during the first trimester "...unless the expected benefit is large and unique" [9].

BREAST FEEDING: Pseudoephedrine is excreted into breast milk and may suppress lactation [10, 11]. The reported milk:plasma ratio (at 3 hours) is 3.9 [10]. At the maximum recommended pseudoephedrine doses, the calculated infant dose delivered via milk is less than 10% of the maternal dose [11]. The American Academy of Pediatrics and the WHO Working Group on Human Lactation consider the occasional use of pseudoephedrine to be compatible with breast feeding [12, 13].

NEONATAL SIDE EFFECTS: Agitation

SEARCH LITERATURE

ADDITIONAL READING: Over the Counter Cold Medications in Pregnancy
1998 Illinois Teratogen Information Service

1.Werler MM, et al Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol. 2002;155:26-31 MEDLINE
2. Hoyme HE, et al. ;The vascular pathogenesis of gastroschisis: intrauterine interruption of the omphalomesenteric artery.J Pediatr. 1981;98:228-31.MEDLINE
3. Reid KP, et al., The epidemiologic incidence of congenital gastroschisis in Western Australia. Am J Obstet Gynecol. 2003;189:764-8. MEDLINE
4. Nichols CR, et al., Rising incidence of gastroschisis in teenage pregnancies. J Matern Fetal Med. 1997;6:225-9.MEDLINE
5. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition, Baltimore, MD: Williams & Wilkins,2002 p 1187.
6. Aselton P et al. First-trimester drug use and congenital disorders. Obstet Gynecol. 1985;65:451-5.  MEDLINE
7. Jick H et al. First-trimester drug use and congenital disorders.JAMA. 1981;246:343-6.  MEDLINE
8. Schatz M et al. The safety of asthma and allergy medications during pregnancy. J Allergy Clin Immunol. 1997;100:301-6.MEDLINE
9. The use of newer asthma and allergy medications during pregnancy. Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE
10. Findlay JW et al: Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol 18:901-6, 1984.  MEDLINE
11. Aljazaf K, Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk.Br J Clin Pharmacol. 2003;56:18-24. PMID:  MEDLINE
12. The WvHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier, Amsterdam, New York, Oxford, 1988.
13.Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.

 


Pyrantel pamoate
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Pyridostigmine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Pyridoxine
CATEGORY: A
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Pyrimethamine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Vomiting, marrow suppression

CERCA LETTERATURA


Quinapril
Antihypertensive; ACE inhibitor
CATEGORY: C first trimester
CATEGORY: D second and third trimesters

2nd and 3rd trimester ACE inhibitor exposure is associated with hypocalvaria, and renal defects related to fetal hypotension and decreased renal perfusion. The latter may result in oligohydramnios.
BREAST FEEDING: Excreted into human milk. Compatible [1].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1.Begg EJ, Robson RA, Gardiner SJ, Hudson LJ, Reece PA, Olson SC, Posvar EL, Sedman AJ. Quinapril and its metabolite quinaprilat in human milk. Br J Clin Pharmacol. 2001 May;51(5):478-81. MEDLINE


Quinidine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Anemia,rash,arrhythmias,optic neuritis

CERCA LETTERATURA


Raloxifene
Selective estrogen receptor modulator (SERM)
CATEGORY:X
BREAST FEEDING: Contraindicated
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Ramipril
Antihypertensive; ACE inhibitor
CATEGORY: C first trimester
CATEGORY: D second and third trimesters

2nd and 3rd trimester ACE inhibitor exposure is associated with hypocalvaria, and renal defects related to fetal hypotension and decreased renal perfusion. The latter may result in oligohydramnios.
BREAST FEEDING: Excreted into human milk. The manufacturer does not consider this drug to be compatible with breast feeding.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Ranitidine
Treatment of peptic disorders, Antihistamine (H2 Receptor Antagonist)
CATEGORY:B
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS: Reduces gastric acidity

CERCA LETTERATURA


Reserpine
Antihypertensive Agent
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:Galactorrhea

CERCA LETTERATURA


Rifampin
Antituberculosis Agent
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Risperidone
Antipsychotic, Antimanic
CATEGORY: C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Rofecoxib
Nonsteroidal Anti-Inflammatory, cyclooxygenase-2 inhibitor
CATEGORY: C
Animal studies showed a treatment dependent decrease in the diameter of the ductus arteriosus. No delay in labor or parturition was seen. There is no data on the use of rofecoxib during human pregnancy.
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Salmeterol xinafoate

Salmeterol xinafoate (Serevent Diskus ®)
Bronchodilator, inhaled ß 2-agonist. Molecular weight:603.8
CATEGORY: C

Among 47 infants whose mothers used salmeterol during early pregnancy, one case of Aarskog syndrome (short stature, musculoskeletal, and genital anomalies) was reported which was unlikely to be associated with salmeterol exposure [1].

Preliminary data from The Organization of Teratology Information Services (OTIS)  prospective cohort study of asthma medications in pregnancy did not support an association between salmeterol and major malformations, growth disturbances, spontaneous abortion, premature delivery, or preeclampsia. The OTIS study compared the outcomes of 126  mothers who used salmeterol during pregnancy ( 90% had used the drug during first trimester) with 91 mothers who used only short-acting beta agonists and 115 non-asthmatic women. Malformations in the salmeterol group included 1 case of bicuspid aorta with penoscrotal fusion, 1 case of bilateral and 3 cases of unilateral inguinal hernia [2].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) would not recommended salmeterol for use during pregnancy in preference to older ß 2-agonists, cromolyn or beclomethasone. However, salmeterol may be beneficial for patients who have moderate-severe asthma and have shown a good response to this drug prior to pregnancy [3].

BREAST FEEDING: "Since there are no data from controlled trials on the use of salmeterol xinafoate by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Plasma levels of salmeterol after inhaled therapeutic doses are very low. Caution should be exercised when salmeterol xinafoate is administered to a nursing woman"[4].

SEARCH LITERATURE

1. Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 1998;105:882-9. MEDLINE
2. Jones KL et al. Salmeterol Use and Pregnancy Outcome: A Prospective Multi-Center Study. American Academy of Allergy, Asthma and Immunology 58th annual meeting. New York, New York, USA. March 1-6, 2002. J Allergy Clin Immunol. [Abstract] 2002 ;109:S21-446. MEDLINE
3. The use of newer asthma and allergy medications during pregnancy. Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE
4. Serevent® Diskus® package insert, GlaxoSmithKline.2003
.
 


Secobarbital
CATEGORY:D
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Withdrawal

CERCA LETTERATURA


Sertraline
Antidepressant. Selective serotonin reuptake inhibitor (SSRI). Molecular weight:342.7
CATEGORY:C

"Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) on a mg/m 2 basis. There was no evidence of teratogenicity at any dose level.

When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 0.5 times the MRHD in rats and 4 times the MRHD in rabbits. When female rats received sertraline at a dose of 20 mg/kg (1 times the MRHD) during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during the first 4 days after birth." [1].

Transplacental passage in humans has been demonstrated with a mean ratio of cord to maternal serum concentration of 0.29 (range 0.10 to 0.66) after maternal doses of  25 to 150 mg day [2].

A prospective study of women followed by The California Teratogen Information Service found no increase in the rate of major anomalies in the infants of 112 women who had  used sertraline during pregnancy when compared to nonexposed controls. Anomalies reported in the sertraline exposed group included bilateral choanal atresia, valvular pulmonic stenosis with an atrial septal aneurysm, unilateral club foot, and Down syndrome in a pregnancy that was terminated.  Infants exposed to sertraline during the third trimester were more likely than controls to have neonatal transition difficulties and were more often admitted to a special care nursery [3]

Kulin NA et. al. prospectively examined 147 women who reported use of  sertraline during the first trimester pregnancy. The rates of miscarriage, stillbirth, prematurity, mean birth weight, and major malformations in the women who used sertraline were comparable to unexposed controls. Most of the women had taken 50 mg daily (range 25-250 mg/d) [4] .

Hendrick V, et. al. found no increased rate of congenital anomalies in a group of 36 women who had received sertraline therapy at any time during pregnancy. Reported complications included three newborns admitted to the special care nursery because of transient tachypnea of newborn, and another infant admitted to special care because of esophageal perforation during mouth suctioning [5].

BREAST FEEDING: Sertraline and its active metabolite desmethylsertraline are excreted into breast milk.

A study of fifteen nursing women taking sertraline  (25-200 mg/day) found the milk/plasma ratio to be highly variable (range, 0.42-4.81). The highest concentrations of sertraline and desmethylsertraline were observed 8 to 9 hours after maternal ingestion[6].

In another study of eight women taking sertraline the milk/plasma ratios of 1.93 and 1.64 were estimated for sertraline and N-desmethylsertraline respectively. Infant exposure calculated from estimated milk production (0.15 l kg(-1) day(-1)), was estimated to be  0.90% and 1.32% for sertraline and N-desmethylsertraline respectively [7].

Hendrick V et. al. , found no detectable medication (parent and/or metabolite) present in the majority of  (25/33) the serum samples obtained from 30 infants exposed to sertraline  through breast-feeding. Sertraline was significantly more likely to be detected in an infant if the mother's daily dose was 100 mg or higher [8].

The American Academy of Pediatrics has classified sertraline as a drug "for which the effect on nursing infants is unknown but may be of concern" [9].

NEONATAL SIDE EFFECTS:

Nystagmus has been observed in the newborn of a mother who had been taking sertraline 50 mg daily for the two weeks preceding delivery. The nystagmus resolved by 72 hours postpartum [10].

As previously mentioned, Chambers CD, et. al. found infants who had been exposed to sertraline during the third trimester were more likely than controls to have neonatal transition difficulties and more likely to be admitted to a special care nursery [3].

One case report described  "...agitation, restlessness, poor feeding, constant crying, insomnia and enhanced startle reaction." after abrupt cessation of breast feeding in an infant whose mother had been taking the maximum recommended daily dose of 200 mg daily [1] throughout most of her pregnancy and during lactation. Symptoms were persistent for 48 hours and subsided over next few days [11].

In contrast to the above case report, Hendrick V et. al. did not observe symptoms suggesting neonatal withdrawal in 11 infants after prenatal exposure to sertraline at doses of 25 to 150 mg per day [2].

SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2003: 2678-80.
2.Hendrick V, et. al. Placental passage of antidepressant medications. Am J Psychiatry. 2003;160:993-6. MEDLINE
3. Chambers CD, et. al.  Pregnancy outcome in women who use sertraline. Teratology 1999;59:376.
4. Kulin NA, et al: Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA. 1998;279:609-10. MEDLINE
5. Hendrick V et al. Birth outcomes after prenatal exposure to antidepressant medication. Am J Obstet Gynecol. 2003;188:812-5.MEDLINE
6. Stowe ZN, et al. The pharmacokinetics of sertraline excretion into human breast milk: determinants of infant serum concentrations. J Clin Psychiatry. 2003 ;64:73-80.MEDLINE
7. Kristensen JH, et al. Distribution and excretion of sertraline and N-desmethylsertraline in human milk. Br J Clin Pharmacol. 1998;45:453-7.MEDLINE
8. Hendrick V, et al. Use of sertraline, paroxetine and fluvoxamine by nursing women.Br J Psychiatry. 2001;179:163-6. MEDLINE
9.American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89.
10. Oca MJ, Donn SM. Association of maternal sertraline (Zoloft) therapy and transient neonatal nystagmus. J Perinatol. 1999;19:460-1.MEDLINE
11. Kent LS and Laidlaw JD. Suspected congenital sertraline dependence.[Letter] Br J Psychiatry. 1995;167:412-3. MEDLINE

ADDITIONAL READING (Patient oriented): Zoloft (sertraline) and Pregnancy (PDF file)
2002 Organization of Teratology Information Services


Simethicone
Defoaming agent used to relieve flatulence. Mixture of dimethyl polysiloxanes and silica gel. Molecular weight between 14,000 and 21,000
CATEGORY: C

A study in volunteers measuring silicon in the blood (as the surrogate marker for simethicone) noted that blood and urine levels of silicone were similar at baseline and after receiving a simethicone-coated cellulose suspension (SonoRx® )or vehicle control. This suggests minimal systemic absorption of simethicone [1].

SEARCH LITERATURE

1. SonoRx® product label, 1998.


Simvastatin
Antilipemic Agent, HMG-CoA reductase inhibitor
CATEGORY:X
Inadvertent exposure in 134 pregnancies to lovastatin or simvastatin resulted in no increased risk of anomaly [1].
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Manson JM,et al.Postmarketing surveillance of lovastatin and simvastatin exposure during pregnancy.Reprod Toxicol; 10,439,1996 MEDLINE


Sulbactam
CATEGORY:B
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Spironolactone
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Sulfapyridine/sulfisoxazole
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Caution in infant with jaundice or G-6-PD deficiency and ill, stressed, or premature infant.

CERCA LETTERATURA


Sulfasalazine
CATEGORY:B
BREAST FEEDING: With caution.[G3].
NEONATAL SIDE EFFECTS: Bloody diarrhea.

CERCA LETTERATURA


Sumatriptan
CATEGORY:C
BREAST FEEDING: Negligible excretion into breast milk. Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Technitium-99m
CATEGORY:X
BREAST FEEDING: Contraindicated Radioactivity in milk for 3 days
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Temazepam
CATEGORY:X
Stillbirth has been reported following the use of diphenhydramine and temazepam in combination during human pregnancy [G1 ].
BREAST FEEDING: The American Academy of Pediatrics has classified temazepam as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS: Irritability

CERCA LETTERATURA


Terbinafine
Antifungal
CATEGORY:B
BREAST FEEDING: Excreted into breast milk. Contraindicated.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Terbutaline
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Agitation and vomiting

CERCA LETTERATURA


Terfenadine
Anihistamine.  Molecular weight:471.68

Terfenadine was removed from the marketplace in the United States in 1998 after the approval of a safer alternative drug Allegra (fexofenadine hydrochloride). Fexofenadine hydrochloride provides the same benefits of terfenadine, but appears to have less potential for the cardiac toxicity of terfenadine.

CATEGORY:C [1]

Studies performed in pregnant rats and rabbits at daily oral doses up to 300 mg/kg/day were not teratogenic in either rats or rabbits [2].

Briggs et. al. reported on data from a surveillance study of Michigan Medicaid recipients conducted between 1985 and 1992. Amongst 1,034 newborns who had been exposed to terfenadine during the first trimester there were 12 cases of  polydactyly (3 cases were expected). The data did not otherwise support an association between terfenadine and major malformations (cardiovascular defects, oral clefts, spina bifida, limb reduction defects, and hypospadias) [1].

Schick et al. compared the outcomes of 125 mothers who used terfenadine during early pregnancy with a matched control group. There was no significant difference in adverse pregnancy outcomes between the two groups [3].

In a multicenter prospective study of one hundred eighteen women exposed to terfenadine during pregnancy 65 women were exposed to terfenadine during the first trimester. Among women exposed during the first trimester rates of major malformations in the terfenadine group did not differ from rates in matched control subjects.  Gestational age at delivery, rates of preterm deliveries, and developmental milestones were comparable between the groups. Although the birth weight in the terfenadine-exposed newborns was significantly lower compared with that in their matched control subjects the rate of small for gestational age infants was not different between the groups [4]

The Israeli Teratogen Information Service prospectively identified two birth defects (one child with congenital hip dysplasia and one with bilateral inguinal hernia) amongst 27 pregnancies exposed to terfenadine during the first trimester. The authors of the study reported that the rate of anomalies was not significantly different from that of a control group with nonteratogenic exposures[5].

BREAST FEEDING:  In a study of  four healthy lactating mothers subjects received 60 mg terfenadine every 12 hours over a period of 48 hours. Terfenadine was not detected in milk or plasma. However, fexofenadine (the active metabolite of terfenadine) was found in milk and plasma.

The AUCmilk/AUCplasma (0-12) ratio for fexofenadine was 0.21 (range 0.12 to 0.28)

Newborn dosage estimates based on the highest measured concentration of fexofenadine in milk suggest the maximum level of newborn exposure would not exceed 0.45% of the recommended maternal weight-corrected dose  [6]


SEARCH LITERATURE

1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1321-22
2. Gibson JP et al. Preclinical safety studies with terfenadine.  Arzneimittelforschung. 1982;32:1179-84.MEDLINE
3. Schick B, et al. Terfenadine (Seldane) exposure in early pregnancy. Teratology [Abstract] 1994;49:417.
4. Loebstein R, et al. Pregnancy outcome after gestational exposure to terfenadine: A multicenter, prospective controlled study.J Allergy Clin Immunol. 1999 Nov;104(5):953-6. MEDLINE
5. Diav-Citrin O, et al. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study.J Allergy Clin Immunol. 2003; 111: 1239-43. MEDLINE
6. Lucas BD, et al. Terfenadine pharmacokinetics in breast milk in lactating women.Clin Pharmacol Ther. 1995;57:398-402. MEDLINE

 


Tetanus Toxoid
CATEGORY: C
Inactivated toxin of Clostridium tetanus

No evidence exists to indicate that tetanus toxoid administered during pregnancy are teratogenic [1,2]. The American College of Obstetricians and Gynecologists recommends the use of tetanus/diptheria toxoids in pregnant women at risk of acquiring disease or in women who have not recieved a booster within the past ten years [3].

BREAST FEEDING: Compatible [4].
SEARCH LITERATURE

1. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures Recommendations of the Immunization Practices Advisory Committee (ACIP) Morbidity and Mortality Weekly Report August 08, 1991 / 40(RR10);1-28
2. Silveira CM, Caceres VM, Dutra MG et al: Safety of tetanus toxoid in pregnant women: A hospital-based case-control study of congenital anomalies. Bull WHO 73:605-608, 1995.MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12. MEDLINE
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)  

 


Tetracycline
Antibiotic. Molecular weight:444.44

CATEGORY: D

Tetracycline-induced hepatotoxicity and hepatorenal failure have been reported in pregnant women given tetracycline [1-3]

Results of The Collaborative Perinatal Project found no increase in the incidence of major malformations among 341 mother-child pairs exposed during the first trimester to tetracycline. However, the findings of the study suggested a possible association with minor defects (inguinal hernia, hypoplasia of a limb, and hypospadias)[4].

A surveillance study of Michigan Medicaid recipients reported that data on 1004 newborns exposed to tetracycline during the first trimester did not support an association between tetracycline and major malformations, specifically cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias [5].

Tetracycline exposure after the fourth month of pregnancy may result in brownish staining of the deciduous teeth. When administered near term the permanent teeth may also be a stained [6].

BREAST FEEDING:  The American Academy of Pediatrics has classified tetracycline  as a medication "usually compatible with breast feeding" [7]. The WHO Working Group on Human Lactation considered the risk to the infant to be slight when tetracycline is used for less than 10 days [8].

NEONATAL SIDE EFFECTS: Oral tetracycline given to premature infants has been associated with decreased growth of the  fibula . The effect was reversible after the drug was discontinued [9].

SEARCH LITERATURE


1. Pride GL, et al. Disseminated intravascular coagulation associated with tetracycline-induced hepatorenal failure during pregnancy. Am J Obstet Gynecol. 1973;115:585-6. available. MEDLINE
2. Allen ES, et al.Hepatic toxicity of tetracycline in pregnancy.Am J Obstet Gynecol. 1966;95:12-8. MEDLINE
3. Whalley PJ, et al. Disposition of tetracycline by pregnant women with acute pyelonephritis.Obstet Gynecol. 1970;36:821-6. MEDLINE
4. Heinonen OP et al: Birth Defects and Drugs in Pregnancy Littleton, Publishing Sciences Group, 1977, pp 472-486.
5. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1325.
6. Shepard TH. Catalog of Teratogenic Agents pp 1309. 9th ed.Baltimore, MD: Johns Hopkins University Press, 1998 .p2553
7.  Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.
8.The WHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier, Amsterdam, New York, Oxford, 1988.
9. Cohlan SQ et al.Growth inhibition of prematures receiving tetracycline. Am J Dis Child 1963;105:453-461.

 


Theophylline
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Irritability

CERCA LETTERATURA


Thioridazine
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Thyroid hormone
CATEGORY:A
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Ticarcillin
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Diarrhea

CERCA LETTERATURA


Timolol
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hypotension,bradycardia

CERCA LETTERATURA


Tinidazole
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified tinidazole as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].

CERCA LETTERATURA
NEONATAL SIDE EFFECTS: See Metronidazole


Tobramycin
CATEGORY:D
BREAST FEEDING:
NEONATAL SIDE EFFECTS: Diarrhea

CERCA LETTERATURA


Tolbutamide
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Jaundice, hypoglycemia

CERCA LETTERATURA


Tolmetin
CATEGORY:C
See NSAIDS
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Topiramate

CATEGORY:C


Tramadol
CATEGORY:C
No human data. Transient developmental delay seen in animal studies.
BREAST FEEDING: Not recommended. Excreted into breast milk in high concentrations.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Trazodone
Antidepressant. Molecular weight:408.33.
CATEGORY:C [1]

In a studies performed on rats and rabbits no teratogenic effects were found at doses of up to 210 and 75 mg per kg respectively [2].

A surveillance study of Michigan Medicaid recipients reported that data on 100 newborns exposed to trazodone during the first trimester did not support an association between trazodone and major malformations, specifically hypospadias, cardiovascular defects,  limb reduction defects, oral clefts, polydactyly, and spina bifida [1].

Einarson A, et al  found no increased rate in major malformations in 58 pregnancies after first trimester exposure to trazodone [3].

BREAST FEEDING: The excretion of breast milk was studied in six lactating women following the oral administration of a single trazodone tablet (50 mg). The milk/plasma ratio of trazodone  was  0.14 [4].

The American Academy of Pediatrics has classified trazodone as a medication "for Which the Effect on Nursing Infants Is Unknown but May Be of Concern" [5]

SEARCH LITERATURE

1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1374-1375
2. Barcellona PS. Investigations on the possible teratogenic effects of trazodone in rats and rabbits. Boll Chim Farm. 1970;109:323-32. MEDLINE
3. Einarson A, et al. A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy.Can J Psychiatry. 2003;48:106-10.MEDLINE
4. Verbeeck RK et al.Excretion of trazodone in breast milk.Br J Clin Pharmacol. 1986;22:367-70.MEDLINE
5.  Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 ;108:776-89.

 


Triamcinolone acetonide
Corticosteroid, Inhalation Aerosol
CATEGORY:C

BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Triamterene
Antihypertensive, Diuretic
CATEGORY:C
1st trimester exposure in 318 infants resulted in no increase in major or minor anomalies.
BREAST FEEDING: Contraindicated.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Trifluoperazine
Tranquilizer
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified trifluoperazine as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Trimethobenzamide
Antiemetic

CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Trimethoprim/sulfamethoxazole
Anti-Infective
CATEGORY:C

Folic acid antagonists, which include such common drugs as trimethoprim, triamterene, carbamazepine, phenytoin, phenobarbital, and primidone, may increase the risk not only of neural-tube defects, but also of cardiovascular defects, oral clefts, and urinary tract defects.


BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1. Czeizel AE, et al The teratogenic risk of trimethoprim-sulfonamides: a population based case-control study.
Reprod Toxicol. 2001 Nov-Dec;15(6):637-46.
PMID: 11738517
MEDLINE

Hernandez-Diaz SFolic acid antagonists during pregnancy and the risk of birth defects.
N Engl J Med. 2000 Nov 30;343(22):1608-14.
PMID: 11096168

Neural tube defects in relation to use of folic acid antagonists during pregnancy.
Am J Epidemiol. 2001 May 15;153(10):961-8.
PMID: 11384952

Created: 11/17/2000
Last Update: 11/30/2002


Triprolidine
CATEGORY:C


BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Troglitazone
Antidiabetic Agent
CATEGORY:B
BREAST FEEDING: Contraindicated.
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA



Vaccine, Anthrax Adsorbed
CATEGORY: D
Non-live vaccine.

"Preliminary results of a recent unpublished retrospective study of infants born to women in the U.S. military service worldwide in 1998 and 1999 suggest that the vaccine may be linked with an increase in the number of birth defects when given during pregnancy (unpublished data, Department of Defense). Although these data are unconfirmed, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. Animal reproduction studies have not been conducted with BioThrax."[1]. A cohort study of US Army women found no effect on pregnancy and birth rates or adverse birth outcomes in 385 pregnancies following at least 1 dose of anthrax vaccine. However, this study did not have sufficient power to detect adverse birth outcomes [2]. Not routinely recommended except in pregnant women work at high risk for exposure [3].
BREAST FEEDING: Compatible [1,4].

SEARCH LITERATURE

References
1.Bio ThraxTM package insert 2002
2. Wiesen AR, Littell CT.Relationship between prepregnancy anthrax vaccination and pregnancy and birth outcomes among US Army women.JAMA. 2002 Mar 27;287(12):1556-60.MEDLINE

3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE

4. Centers for Disease Control & Prevention. Use of Anthrax Vaccine in the United StatesRecommendations of the Advisory Committee on Immunization Practices MMWR 49 (No. RR-15):1-20, 2000.

 


Vaccine, Cholera
CATEGORY: C
Killed bacteria vaccine.

The effects of cholera vaccine on the developing fetus are unknown. Cholera vaccine may be indicated in pregnancy when susceptibility and exposure to cholera are highly probable such as may occur with travel to areas where the disease is endemic or epidemic.[1].
BREAST FEEDING: Compatible [2].

SEARCH LITERATURE

1. Immunization during pregnancy. ACOG technical bulletin number 160--October 1991. Int J Gynaecol Obstet. 1993 Jan;40(1):69-79. MEDLINE
2. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine,Haemophilus B Conjugate
CATEGORY: C
Capsular polysaccharide vaccine.

No adverse effects were reported after third trimester exposure in 50 pregnancies [1] .
BREAST FEEDING: Compatible[2].

SEARCH LITERATURE

1. Englund JA, Glezen WP, Turner C, Harvey J, Thompson C, Siber GR. Transplacental antibody transfer following maternal immunization with polysaccharide and conjugate Haemophilus influenzae type b vaccines. J Infect Dis 1995; 171: 99-105. MEDLINE
2. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine, Hepatitis A
CATEGORY: C
Inactivated noninfectious vaccine.

The effects of hepatitis vaccine on the developing fetus are unknown. However the theoretical risk to the fetus is low [1], and the vaccine is considered safe for use during pregnancy [2, 3].

BREAST FEEDING: Compatible [4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Prevention of Hepatitis A Through Active or Passive Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 45 (No. RR-15): 20, 1996.
2. Duff B, Duff P.Hepatitis A vaccine: ready for prime time.Obstet Gynecol. 1998;91(3):468-71.  MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994. Glaxo SmithKline Hepatitis A vaccination pregnancy registry – 888-825-5249

 


Vaccine, Hepatitis B
CATEGORY: C.
Inactivated (recombinant) noninfectious vaccine.

Pregnancy and lactation are not contraindications to vaccine [1].The American College of Obstetricians and Gynecologists recommends the use of hepatitis B vaccine for pregnant women at risk of acquiring the disease [2].
 
BREAST FEEDING: Compatible [3,4].

SEARCH LITERATURE

REFERENCES
1. Centers for Disease Control & Prevention. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (No. RR-13): 4, 1991.
2.
ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)

 


Vaccine, Influenza
CATEGORY: C
Inactivated virus vaccine.

Studies of influenza immunization of more than 2,000 pregnant women have demonstrated no adverse fetal effects associated with influenza vaccine. Pregnancy and lactation are not contraindications [1]. The vaccine is recommended by the American College of Obstetricians and Gynecologists " ...in the second and third trimester during the flu season, and  women at high risk for pulmonary complications regardless of the trimester."[2].

BREAST FEEDING: Compatible [3,4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 47 (No. RR-6): 6, 1998.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3.Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4. Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland (PDF file)

 


Vaccine, Measles
CATEGORY:X
Live attenuated virus vaccine.

Contraindicated in pregnancy [1]. Avoid becoming pregnant for 30 days after vaccination with measles containing vaccines [2].
BREAST FEEDING: Compatible[3,4]

SEARCH LITERATURE

1. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
2. Centers for Disease Control & Prevention. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33, 1998.
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)

 


Vaccine, Meningococcus
CATEGORY: C
Killed bacteria vaccine.

Studies have shown the vaccine to be both safe and efficacious when given to pregnant women [1]. The American College of Obstetricians and Gynecologists does not consider the indications for the vaccine to be altered by pregnancy [2].
BREAST FEEDING: Compatible[3,4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Control and Prevention of Meningococcal Disease and Control and Prevention of Serogroup C Meningococcal Disease: Evaluation and Management of Suspected Outbreaks: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 46 (No. RR-5): 5, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 Jan;101(1):207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)


Vaccine, Mumps
CATEGORY:X
Live attenuated virus vaccine.

Mumps virus has been been recovered from the placenta , but not from the fetal tissues of three susceptible pregnant women who were vaccinated before undergoing elective abortions. However, the sample size is too small to rule out the possibility of fetal mumps infection after vaccination with mumps live attenuated virus [1]. The vaccine is  considered to be contraindicated in pregnancy by the American College of Obstetricians and Gynecologists [2]. Avoid becoming pregnant for 30 days after vaccination with mumps containing vaccines [3]
BREAST FEEDING: Compatible [4,5].

SEARCH LITERATURE

1.Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the human placenta. N Engl J Med. 290:710-2, 1974 MEDLINE
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. Measles, Mumps, and Rubella - Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33, 1998.
4. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)

 


Vaccine, Plague
CATEGORY: C
Killed bacteria vaccine.

The effects of plague vaccine on the developing fetus are unknown. Vaccine should be used only if the potential benefits of vaccination outweigh potential risks to the fetus[1].
BREAST FEEDING: Compatible [2].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Prevention of Plague: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 45 (No. RR-14): 10, 1996.
2. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine, Pneumococcal
CATEGORY: C
Killed bacteria vaccine.

No adverse outcomes have been reported among newborns whose mothers were vaccinated during pregnancy [1,2] The American College of Obstetricians and Gynecologists does not consider the indications for the vaccine to be altered by pregnancy. The vaccine is recommended for women with asplenia, metabolic, renal, cardiopulmonoary diseases, smokers and immunosuppressed patients[3].


BREAST FEEDING: Compatible [4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Prevention of Pneumococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 46 (No. RR-8): 6, 1997.
2. Shahid NS, Steinhoff MC, et. al., Serum, breast milk, and infant antibody after maternal immunisation with pneumococcal vaccine.Lancet. 1995 Nov 11;346(8985):1252-7.MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine, Poliovirus Inactivated
CATEGORY: C
Inactivated virus vaccine.

No adverse effects have been reported among pregnant women or their fetuses. However, vaccine should be used only if the potential benefits of vaccination outweigh potential risks to the fetus[1]. Recommended for women at increased risk of exposure [2].
BREAST FEEDING: Compatible[3,4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Poliomyelitis Prevention in the United States: Introduction of a Sequential Vaccination Schedule of Inactivated Poliovirus Vaccine Followed by Oral Poliovirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 46 (No. RR-3): 18, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)  

 


Vaccine, Poliovirus Live
CATEGORY: C
Live trivalent attenuated virus bacteria vaccine.

No adverse effects have been reported among pregnant women or their fetuses. However, vaccine should be used only if the potential benefits of vaccination outweigh potential risks to the fetus[1]. Recommended for women at increased risk of exposure [2].
BREAST FEEDING: Compatible[3].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Poliomyelitis Prevention in the United States: Introduction of a Sequential Vaccination Schedule of Inactivated Poliovirus Vaccine Followed by Oral Poliovirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 46 (No. RR-3): 18, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine, Rabies
CATEGORY: C
Inactivated virus vaccine.

Pregnancy is not considered a contraindication to postexposure prophylaxis [1,2 ]
BREAST FEEDING: Compatible [3,4].

SEARCH LITERATURE

1. Centers for Disease Control & Prevention. Rabies Prevention–United States, 1991: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (No. RR-3): 11-12, 1991.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)

 


Vaccine, Rubella
CATEGORY: C
Live attenuated virus vaccine.

No evidence of congenital rubella syndrome occurred in the offspring of the 226 women who received the current RA 27/3 rubella vaccine and continued their pregnancy to term. Nonetheless women should be counseled to avoid becoming pregnant for 28 days after exposure to rubella-containing vaccines [1,2].

BREAST FEEDING: Excreted into human milk. Recent studies have shown that lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella. Caution should be exercised when MERUVAX II is administered to a nursing woman [3]. Compatible with breastfeeding [4,5].

SEARCH LITERATURE

1.Centers for Disease Control & Prevention. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33, 1998.
2. Revised ACIP Recommendation for Avoiding Pregnancy After Receiving a Rubella-Containing Vaccine
MMWR 50(49);1117, 2001
3.MeruvaxII® vaccine package insert, 2001.
4. Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)


Vaccine,TC-83 Venezuelan Equine Encephalitis
FDACategories.htm">CATEGORY:X [1]
Live attenuated virus vaccine.

Avoid pregnancy for 3 months following vaccination.

BREAST FEEDING: Compatible [2].

SEARCH LITERATURE

1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1431-1433.
2. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.

 


Vaccine, Typhoid
CATEGORY: C
Killed bacteria vaccine.

1st trimester exposure to the oral vaccine in 18 pregnancies resulted in two miscarriages (2.7 expected) and 16 normal infants. However, the sample size is too small to draw firm conclusions [1]. Typhoid vaccine may be indicated in pregnancy when susceptibility and exposure to typhoid are highly probable such as may occur with travel to areas where the disease is endemic or epidemic [2]. The oral vaccine is preferred [3].

BREAST FEEDING: Compatible [4,5].

SEARCH LITERATURE

1. Mazzone T, Celestini E, Fabi R, Pagano M, Serafini MA, Verdecchia P, Mastroiacovo P. Oral typhoid vaccine and pregnancy. Reprod Toxicol 8:278-9, 1994. MEDLINE
2. Immunization during pregnancy. ACOG technical bulletin number 160--October 1991. Int J Gynaecol Obstet. 1993 Jan;40(1):69-79. MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)


Vaccine, Vaccinia - Smallpox

CATEGORY:C [Manufacturer]
CATEGORY:X [1]

Live attenuated virus vaccine.

Vaccinia should not be administered to pregnant women for routine nonemergency indications. Although vaccinia vaccine is not known to cause congenital malformations primary vaccination with vaccinia virus has been reported to cause fetal infection. Fetal vaccinia usually results in stillbirth or death of the infant shortly after delivery. [2,3,4]

There are no absolute contraindications regarding vaccination of a person with a high-risk exposure to smallpox.

BREAST FEEDING: It is not known whether vaccine antigens or antibodies are excreted in human milk. This vaccine is not recommended for use in a nursing mother in non-emergency conditions [2, 4].

SEARCH LITERATURE

1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 5th edition,Baltimore, MD: Williams & Wilkins,1998
2. Centers for Disease Control & Prevention. Vaccinia (Smallpox) Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001 MMWR 50 (No. RR-10): 1-25, 2001.
3. Levine MM. Live-virus vaccines in pregnancy. Risks and recommendations. Lancet. 1974 ;2:34-8. MEDLINE
4. Dryvax ® package insert 2002


Vaccine,Varicella
CATEGORY: C
Live attenuated virus vaccine.

No cases of congenital varicella syndrome were identified after first and second trimester exposure among 56 live births, but the sample size is too small to draw firm conclusions [1] .The American College of Obstetricians and Gynecologists considers the vaccine to be contraindicated during pregnancy [2]. Nonpregnant women who are vaccinated should avoid becoming pregnant for 1 month following each injection [3].
BREAST FEEDING: Compatible [4].

SEARCH LITERATURE

1. Shields KE, Galil K, Seward J, Sharrar RG, Cordero JF, Slater E. Varicella vaccine exposure during pregnancy: data from the first 5 years of the pregnancy registry. Obstet Gynecol. 2001 Jul;98(1):14-9.MEDLINE
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003 ;101:207-12.MEDLINE
3.Centers for Disease Control & Prevention. Prevention of Varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 45 (No. RR-11): 19, 1996.
4. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.


Vaccine, Yellow Fever
CATEGORY: D
Live attenuated virus vaccine.

Robert E, et al. reported on women who had received yellow fever vaccine (YFV) during early pregnancy. Of 58 pregnancies with completed follow-up five ended in voluntary abortions, seven in spontaneous abortion, and  46 births. Three newborns had minor anomalies and two had major defects (ureteral stenosis and triphalangeal hallux)[1].

Women who must travel to areas where the risk of yellow fever is high should be vaccinated. However if a travel requirement is the only reason for vaccination, then efforts should be made to obtain a waiver letter from the traveler’s physician [2].

BREAST FEEDING: Compatible [3, 4].

SEARCH LITERATURE

 

1. Robert E , et al.,Exposure to yellow fever vaccine in early pregnancy. Vaccine. 1999 ;17:283-5.MEDLINE
2. Centers for Disease Control & Prevention. Yellow Fever Vaccine: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 39 (No. RR-6): 3, 1990.
3. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs. pp 23-24 World Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)


Valproic acid
CATEGORY:D
Incidence of neural tube defect (spina bifida) after first trimester exposure is approximately 1% [1].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hepatitis,hemorrhagic pancreatitis

CERCA LETTERATURA

1.Teratology. ACOG technical bulletin number 236--April 1997


Vancomycin
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Vegetarian Diet
-
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:B12 deficiency

CERCA LETTERATURA


Venlafaxine
Antidepressant .Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

Molecular weight: 313.87. The degree of plasma protein binding of venlafaxine is approximately 27% at concentrations ranging from 2.5 to 2215 ng/mL. The degree of plasma protein binding of ODV is approximately 30%  at concentrations ranging from 100 to 500 ng/mL [1].

CATEGORY:C

"Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 11 times (rat) or 12 times (rabbit) the maximum recommended human daily dose on a mg/kg basis, or 2.5 times (rat) and 4 times (rabbit) the human daily dose on a mg/m 2 basis. However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. These effects occurred at 10 times (mg/kg) or 2.5 times (mg/m 2 ) the maximum human daily dose. The no effect dose for rat pup mortality was 1.4 times the human dose on a mg/kg basis or 0.25 times the human dose on a mg/m 2 basis."[1]

Venlafaxine appears to cross the human placenta near term [2].

In a prospective study pregnancy outcomes of 150 women exposed to venlafaxine during first trimester were compared with the pregnancy outcomes of a group of pregnant women who received selective serotonin reuptake inhibitor antidepressants and a group of women who received nonteratogenic drugs. The majority of the women in the venlafaxine group took 75 mg/day (range 37.5 to 300 mg/day) of venlafaxine immediate release form. Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions and seven had therapeutic abortions; two of the babies had major malformations. Birthweight, gestational age at delivery, and the rate of major malformations did not differ amongst the three groups [3].

The small number of human pregnancies exposed to venlafaxine to date are insufficient to allow a general conclusion regarding the teratogenic risk of venlafaxine.
 

BREAST FEEDING: Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV) are excreted into human milk. In a small case series of three lactating women taking venlafaxine for depression the mean milk/plasma ratio for venlafaxine was 4.1 (range 2.8-4.8) and 3.1 for ODV (range 2.8-3.8). The mean total infant dose (as V equivalents) was 7.6% (range 4.7-9.2%) of the maternal weight-adjusted dose, with approximately equal amounts of V (3.5%) and ODV (4.1%) in the dose. Although ODV was detected in the plasma of all three infants no adverse effects were noted in the infants [4].

Hendrick V, et al. also found ODV in the plasma of two breast fed infants whose mothers were treated with venlafaxine 75 and 150 mg/day. Neither infant experienced adverse effects from venlafaxine exposure through breast milk, and their development appeared to be normal  over the first year [5].


NEONATAL SIDE EFFECTS: Restlessness, hypertonia, jitteriness, irritability and poor feeding occurred in a neonate after maternal use of venlafaxine for depression during pregnancy. The diagnosis was confirmed by a temporary improvement after administration of a low dose (1 mg) of venlafaxine to the boy. The symptoms ceased after 8 days [6].

SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 3413-3415
2. Hostetter A, et al. Amniotic fluid and umbilical cord blood concentrations of antidepressants in three women.Biol Psychiatry. 2000;48:1032-4.MEDLINE
3.Einarson A, et al.. Pregnancy outcome following gestational exposure to venlafaxine: a multicenter prospective controlled study. Am J Psychiatry. 2001;158:1728-30. MEDLINE
4. Ilett KF, Hackett LP, Dusci LJ, Roberts MJ, Kristensen JH, Paech M, Groves A, Yapp P. Distribution and excretion of venlafaxine and O-desmethylvenlafaxine in human milk. Br J Clin Pharmacol. 1998;45:459-62. MEDLINE
5. Hendrick V, et al. Venlafaxine and breast-feeding.[Letter]Am J Psychiatry. 2001;158:2089-90.  MEDLINE
6. de Moor RA et al. [Withdrawal symptoms in a neonate following exposure to venlafaxine during pregnancy] Ned Tijdschr Geneeskd. 2003;147:1370-2. MEDLINE

 


Verapamil
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Vitamin A
CATEGORY:A
CATEGORY:X in high doses.

High doses produce urogenital anomalies and defects similar to isotretinoin
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

ADDITIONAL READING: Vitamin A and Pregnancy
1996 Illinois Teratogen Information Service


Vitamin B12
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Vitamin D

BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:Hypercalcemia

CERCA LETTERATURA


Warfarin
CATEGORY:D
Anticoagulant
Embryopathy: Nasal hypoplasia, stippling of secondary epiphysis, IUGR, anomalies of eyes, hands, neck, and CNS. Up to 25% risk of an affected infant following exposure until the 14th week of pregnancy. Later exposure is associated with fetal hemorrhage, abruption, and stillbirth [1].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA

1.Teratology. ACOG technical bulletin number 236--April 1997


Zidovudine
CATEGORY:C
BREAST FEEDING: Breast feeding is contraindicated in HIV infection
NEONATAL SIDE EFFECTS:

CERCA LETTERATURA


Zolpidem

Zolpidem (Ambien ®)
Hypnotic. Non-benzodiazepine of the imidazopyridine class, shares some of the pharmacological properties of the benzodiazepines. Molecular weight:764.88
CATEGORY: B

Reproductive studies conducted in rats and rabbits showed no teratogenic effects after zolpidem administration. In rats and rabbits no fetal toxicity was noted at 5 times and 7 times the maximum human dose (on a mg/m 2 basis) respectively.  [1]

In rats, adverse maternal and fetal effects occurred at 20 and 100 mg base/kg and included dose-related maternal lethargy and ataxia and a dose-related trend to incomplete ossification of fetal skull bones. In rabbits there was an increase in postimplantation fetal loss and underossification of sternebrae in viable fetuses at the dose of 16 mg base/kg. These fetal findings in rabbits are often secondary to reductions in maternal weight gain  [1].

Although animal studies have been reassuring data on the use of zolpidem during human pregnancy is minimal. In one observational study from England first trimester exposure in 18 pregnancies (including one set of twins) resulted in delivery of 11 normal infants and two spontaneous abortions. Six women chose to have elective abortions [2].

BREAST FEEDING: Excretion of zolpidem into human milk appeared to be very low (less than 0.02% of the total administered dose) in a study of five lactating women treated with a single 20 mg dose of zolpidem. The milk:plasma ratio was 0.13 at 3 hours [3]. The American Academy of Pediatrics considers zolpidem to be compatible with breastfeeding [4].


NEONATAL SIDE EFFECTS: Although withdrawal may occur with excessive doses of zolpidem, the incidence of rebound insomnia or withdrawal symptoms after discontinuation of the drug when it is given as recommended appears to be much lower than that of benzodiazepines [5-7]. Nonetheless children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy. [1]

SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 3008
2. Wilton LV, Pearce GL, Martin RM et al: The outcomes of pregnancy women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 105:882-889, 1998. MEDLINE
3. Pons G, et al., Zolpidem excretion in breast milk. Eur J Clin Pharmacol. 1989;37:245-8. MEDLINE
4. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-89.
5. Aragona M.Abuse, dependence, and epileptic seizures after zolpidem withdrawal: review and case report.Clin Neuropharmacol. 2000;23:281-3. MEDLINE
6. Hajak G, et al., Abuse and dependence potential for the non-benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data.Addiction. 2003;98:1371-8 MEDLINE
7. Holm KJ and Goa KL.Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59:865-89. MEDLINE

 


GENERAL REFERENCES
G1.Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002

 
G2. Cunningham GF, MacDonald PC et al (eds);Williams Obstetrics,20th ed,Stamford ,CT:.Appleton and Lange, 1997
G3. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.
G4 .Shepard TH. Catalog of Teratogenic Agents. 9th ed.Baltimore, MD: Johns Hopkins University Press, 1998
G5. Gleicher Norbert ed. Principles & Practice of Medical Therapy in Pregnancy. 3rd ed. Stamford, CT: Appleton & Lange, 1998
G6. Physicians' Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company,2000
G7. Centers for Disease Control & Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
G8. The WHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier, Amsterdam, New York, Oxford, 1988.
G9.Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human breast milk. Pediatrics 93:137-150, 1994.
G10.Heinonen OP, Slone D, Shapiro S: Birth defects and drugs in pregnancy. Littleton:Publishing Sciences Group, 1977