Clorazepate Pregnancy and Breastfeeding Warnings

Clorazepate is also known as: Tranxene, Tranxene SD, Tranxene T-Tab

Clorazepate Pregnancy Warnings

Clorazepate has not been formally assigned to a pregnancy category. Use of other benzodiazepines is associated with an increased risk in congenital malformations. Only limited experience with the use of clorazepate during pregnancy has been reported. Additionally, an increased risk of congenital malformations in humans has been associated with use of all known anticonvulsant agents in the treatment of women with epilepsy. However, epilepsy itself may be associated with an increased risk of congenital malformations. Clorazepate should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

One study has reported that clorazepate given to women by intramuscular injection during the first stage of labor crosses the placental barrier slowly and is detectable in the blood of neonates. The principal metabolite of clorazepate, N-desmethyldiazepam, crosses the placental barrier more rapidly. Neonatal respiratory depression and neonatal withdrawal have been reported after maternal use of other benzodiazepines and are a theoretical risk of clorazepate therapy. Once case report has described multiple malformations in the offspring of a woman who took 23 capsules of clorazepate during the first trimester. The malformations included: abdominal distention, an oval mass in the suprapubic area, a skin tag at the site of the penis, absence of a urethral opening, absence of a scrotum, absence of an anus, and multiple malformations of the extremities. The infant died at 24 hours of age. Autopsy revealed absence of one lobe of the right lung, absence of the cecum and rectum, marked dilatation of the colon, fistula between the colon and bladder, absence of the right kidney, presence of a rudimentary left kidney, and several supernumerary spleens. To provide information regarding the effects of in utero exposure to clorazepate, physicians are advised to recommend that pregnant patients taking clorazepate enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Clorazepate Breastfeeding Warnings

Clorazepate and/or its principal metabolite, N-desmethyldiazepam, are excreted into human milk in small amounts. No adverse effects have been reported in nursing infants, but experience is quite limited. The American Academy of Pediatrics has no position on the use of clorazepate during breast-feeding but describes other benzodiazepines as drugs "whose effect on nursing infants is unknown but may be of concern". The manufacturer states that clorazepate should not be given to nursing mothers since it has been reported that nordiazepam is excreted in human breast milk.

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