Limbitrol and Pregnancy
The FDA has assigned both pregnancy Category C and D classifications to Limbitrol. Pregnancy category C is given to drugs that appear to cause harm to fetuses in animal studies, and pregnancy Category D is given to drugs that have shown clear evidence of risk to the fetus in human studies. If you are taking Limbitrol and pregnancy occurs, tell your healthcare provider right away.
Limbitrol® (chlordiazepoxide and amitriptyline) may not be safe for pregnant women. Limbitrol is a combination medication, containing chlordiazepoxide (Librium®) and amitriptyline (Elavil®). Chlordiazepoxide is a benzodiazepine, and amitriptyline is a tricyclic antidepressant. Studies have shown that many benzodiazepines may cause problems when used during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in human studies, while pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating
Chlordiazepoxide is a pregnancy Category D medication, due to an increased risk of birth defects and other problems in humans. Amitriptyline is a pregnancy Category C medication because it has been shown to cause birth defects and other problems in animals. Some sources list Limbitrol as a Category C medication, while others list it as a Category D medication. The FDA has not given Limbitrol a specific category (as is common with older medications, especially combination medications).