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Key value for chemical safety assessment

Effects on fertility

Description of key information

There have been reports of increases in severe congenital anomalies in infants whose mothers took chlordiazepoxide and other benzodiazepines (including oxazepam) during pregnancy; there have also been reports claiming no link between benzodiazepine use and fetal abnormalities.

Saito et al. (1984) found increases in fetal toxicity (resorptions, dead fetuses and malformations) in pregnant rats given doses of diazepam or chlordiazepoxide of 100 mg/kg per os during gestational days 7 to 14.

[NTP Technical Report On TheToxicology And Carcinogenesis Studies Of Oxazepam (CAS NO. 604-75-1) IN F344/N Rats October 1998 NTP TR 468 NIH Publication No. 99-3958]

Possible reproductive hazard. Suspected of damaging fertility or the unborn child. Results were mixed in a meta-analysis of studies that tracked the occurrence of major malformations in infants of mothers who used a benzodiazepine in early pregnancy. There have been reports of newborns exhibiting flaccidity, breathing and feeding problems, and hypothermia after maternal use of benzodiazepines in late pregnancy, and withdrawal symptoms, e.g. tremor and irritability, have been seen in newborns exposed to benzodiazepines in utero.

[SDS U. S. Pharmacopeia. Version #: 02 Revision date: 01-19-2015 Issue date: 11-23-2009]

Study in primiparous rats treated during pregnancy and in lactating females rats: apparently teratogenic.

[SDS U. S. Pharmacopeia. Version #: 02 Revision date: 01-19-2015 Issue date: 11-23-2009]

Justification for classification or non-classification