Clorazepate Pregnancy and Breast Feeding Warnings
Clorazepate is also known as: Tranxene, Tranxene SD, Tranxene T-Tab
Overview
Clorazepate Sustained-Release Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clorazepate Sustained-Release Tablets while you are pregnant. Clorazepate Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Clorazepate Sustained-Release Tablets.
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. 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.
Clorazepate Lactation 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".
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