Halazepam Pregnancy and Breastfeeding Warnings
Brand names: Paxipam
Halazepam Pregnancy Warnings
Halazepam has been assigned to pregnancy category D by the FDA. An increased risk of congenital malformations in humans has been associated with use of other benzodiazepines. Withdrawal symptoms have been reported in neonates whose mothers took other benzodiazepines during pregnancy. There are no controlled data in human pregnancy. Halazepam should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
Halazepam Breastfeeding Warnings
There are no data on the excretion of halazepam into human milk. Other benzodiazepines are excreted into human milk and have been reported to have clinically significant effects on the breast-fed infant. Those reported effects include sedation, lethargy, and weight loss. The American Academy of Pediatrics has no position on the use of halazepam during lactation but has classified other benzodiazepines as "drugs whose effect on nursing infants is unknown but may be of concern".
References for pregnancy information
- Bracken MB, Holford TR (1981) "Exposure to prescribed drugs in pregnancy and association with congenital malformations." Obstet Gynecol, 58, p. 336-44
- Scanlon JW (1975) "Effect of benzodiazepines in neonates." N Engl J Med, 292, p. 649
- (2001) "Product Information. Paxipam (halazepam)." Schering Corporation
- Koren G, Pastuszak A, Ito S (1998) "Drugs in pregnancy." N Engl J Med, 338, p. 1128-37
References for breastfeeding information
- Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
- Wesson DR, Camber S, Harkey M, Smith DE (1985) "Diazepam and desmethyldiazepam in breast milk." J Psychoactive Drugs, 17, p. 55-6
- Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.