Diazepam Pregnancy and Breastfeeding Warnings
Diazepam is also known as: Diastat, Diastat AcuDial, Diastat Pediatric, Diazepam Intensol, Dizac, Valium, Valrelease, Zetran
Overview
Diazepam Gel may 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 Diazepam Gel while you are pregnant. Diazepam Gel is found in breast milk. Do not breast-feed while using Diazepam Gel. Discuss with your doctor how long you should wait to breast-feed after using Diazepam Gel.
Diazepam Pregnancy Warnings
There have been reports of respiratory and feeding difficulties as well as hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. One case report has suggested that diazepam use during labor may cause neonatal apnea and hypotonia. In that case report, therapy with flumazenil rapidly reversed the hypotonia and apnea. One study has reported the distribution of diazepam in first trimester pregnancy. In that study women who were about to undergo legal abortion were given diazepam four hours prior to the procedure. Placental tissue samples revealed a diazepam penetration of 49%. Neither diazepam nor its metabolite N-desmethyldiazepam were detectable in the amniotic fluid. 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 not been formally assigned to a pregnancy category. An increased risk of congenital malformations in humans has been associated with use of diazepam in pregnancy, particularly during the first and second trimesters. Chronic use of diazepam in later pregnancy has been associated with neonatal withdrawal and a floppy infant syndrome. There are no controlled data in human pregnancy. Diazepam should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
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.
Although reports have been conflicting, diazepam and its pharmacologically active metabolite n-desmethyldiazepam have been reported to have been 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.
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