Dalmane Pregnancy Warnings
UK: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US: Use is contraindicated.
US FDA pregnancy category: C
Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy. There are no adequate studies in pregnant women.
US: To provide information regarding the effects of in utero exposure to this drug, healthcare providers are advised to recommend that pregnant patients taking this drug enroll in the North American Anti-epileptic Drug (NAAED) Pregnancy Registry. Patients can call the toll-free number 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
