Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.There are three drugs sometimes prescribed for people with bipolar disorder that are in Pregnancy Category X and are not safe to take during pregnancy or breastfeeding: benzodiazepines a type of anti-anxiety and/or sedative medications. Dalmane, Halcion and Restoril are used to treat insomnia.
The use of the product is contraindicated in women who are or may become pregnant.
There is ample evidence that these drugs are not safe to take during pregnancy. When taken early in the pregnancy, there is an unacceptable risk of damage to the fetus, and if a pregnant women takes one of them later in the pregnancy, the newborn baby may suffer withdrawal symptoms starting within a few days to three weeks after birth. The most common birth defects are cleft lip and cleft palate.
These three medications should also not be taken when breastfeeding, as they do pass through breast milk, which can lead to other problems such as severe sedation.
Drugs Contraindicated in Pregnancy. Monthly Prescribing Reference. Jan 14 2009.
Iqbal, M., Sobhan, T. and Ryals, T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatric Services. Vol 53 (Jan 2002).
FDA Use-in-Pregnancy Ratings. Perinatology.com.