In Utero Exposure to Antipsychotics
May 2011, ObGyn News, Lee S. Cohen, MD
New FDA Warning on the Use of Antipsychotic Medications in Pregnancy
On February 22, 2011, the U.S. Food and Drug Administration (FDA) informed healthcare professionals that drug labels for the entire class of antipsychotic drugs have been updated to include warnings regarding the use of antipsychotic drugs during pregnancy. The new drug labels now contain more details on the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns exposed to these drugs during the third trimester of pregnancy.
FDA Proposes Major Revision of Prescription Drug Labeling
The U.S. Food and Drug Administration (FDA) has proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. As it stands, the current system used by the FDA classifies the reproductive safety of medications using five risk categories (A, B, C, D and X) based on data derived from human and animal studies. While widely used to make decisions regarding the use of medications during pregnancy, many have criticized this system of classification, indicating that this type of drug labeling is often not helpful and, even worse, may be misleading.
Recent Antidepressant Label Changes
In October, the Food and Drug Administration (FDA) ordered drug manufacturers to include warnings in the packaging inserts regarding the use of certain antidepressants, including the selective serotonin reuptake inhibitors (SSRIs) and venlafaxine (Effexor), during pregnancy. The labels now describe a spectrum of adverse events in newborns exposed to these drugs late in the third trimester, including jitteriness, irritability, hypoglycemia (low blood sugar), feeding difficulties, respiratory distress, abnormal muscle tone, and constant crying. Complications requiring “prolonged hospitalization, respiratory support and tube feeding” are also mentioned.