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Diazepam Pregnancy and Breastfeeding Warnings

Diazepam is also known as: Diastat, Diastat AcuDial, Diastat Pediatric, Diazepam Intensol, Dizac, Valium, Valrelease, Zetran

Diazepam Pregnancy Warnings

Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

Diazepam has been assigned to pregnancy category D by the FDA. It has been suggested that there is an increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs. There may be nonteratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. Children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at risk of experiencing withdrawal symptoms during the postnatal period. Diazepam has been shown to be teratogenic in animal studies at approximately eight times the maximum recommended human dose. The manufacturer recommends that the use of diazepam in women of childbearing potential, and specifically during known pregnancy, should only be considered when the clinical situation warrants the risk to the fetus. If diazepam is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug. Special care should be taken when diazepam is used during labor and delivery, because high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonate. With newborn infants, the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).

See references

Diazepam Breastfeeding Warnings

One report on concentrations in breast milk of medications used during general anesthesia has stated that diazepam and nordiazepam were not detectable in any sample of milk or blood. This report stated that the maximum possible infant exposure index for diazepam would be 3%. Therefore, the authors concluded that the amount of diazepam excreted into breast milk when used for general anesthesia does not warrant interruption in breast-feeding. Some clinicians feel that in cases where a benzodiazepine is required on a continuing basis and the mother feels strongly about continuing to breast-feed, a short acting benzodiazepine like oxazepam may be a safer alternative.

Diazepam is excreted into human milk. Sedation, lethargy and weight loss have been reported in nursing infants. The American Academy of Pediatrics describes diazepam as a drug whose effect on nursing infants is unknown but may be of concern. The manufacturer states that breast-feeding is not recommended in patients receiving diazepam.

See references

References for pregnancy information

  1. Rementeria JL, Bhatt K "Withdrawal symptoms in neonates from intrauterine exposure to diazepam." J Pediatr 90 (1977): 123-6
  2. Scanlon JW "Effect of benzodiazepines in neonates." N Engl J Med 292 (1975): 649
  3. Gillberg C ""Floppy infant syndrome" and maternal diazepam." Lancet 2 (1977): 244
  4. Bracken MB, Holford TR "Exposure to prescribed drugs in pregnancy and association with congenital malformations." Obstet Gynecol 58 (1981): 336-44
  5. "Product Information. Valium (diazepam)." Roche Laboratories, Nutley, NJ.
  6. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  7. Jorgensen NP, Thurmann-Nielsen E, Walstad RA "Pharmacokinetics and distribution of diazepam and oxazepam in early pregnancy." Acta Obstet Gynecol Scand 67 (1988): 493-7
  8. Cone AM, Nadel S, Sweeney B "Flumazenil reverses diazepam-induced neonatal apnoea and hypotonia." Eur J Pediatr 152 (1993): 458-9
  9. Rothman KJ, Fyler DC, Goldblatt A, Kreidberg MB "Exogenous hormones and other drug exposures of children with congenital heart disease." Am J Epidemiol 109 (1979): 433-9
  10. Haram K ""Floppy infant syndrome" and maternal diazepam." Lancet 2 (1977): 612-3

References for breastfeeding information

  1. Spigset O "Anaesthetic agents and excretion in breast milk." Acta Anaesthesiol Scand 38 (1994): 94-103
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Kuller JA, Katz VL, Mcmahon MJ, Wells SR, Bashford RA "Pharmacologic treatment of psychiatric disease in pregnancy and lactation: fetal and neonatal effects." Obstet Gynecol 87 (1996): 789-94
  4. Wesson DR, Camber S, Harkey M, Smith DE "Diazepam and desmethyldiazepam in breast milk." J Psychoactive Drugs 17 (1985): 55-6
  5. "Product Information. Valium (diazepam)." Roche Laboratories, Nutley, NJ.
  6. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  7. Borgatta L, Jenny RW, Gruss L, Ong CK, Barad D "Clinical significance of methohexital, meperidine, and diazepam in breast milk." J Clin Pharmacol 37 (1997): 186-92

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