Monthly Archives: April 2005

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.