RISK OF SERIOUS GASTROINTENSTINAL BLEEDING WITH NEWER ANTIDEPRESSANT DRUGS

A recently published study identifies gastrointestinal (GI) bleeding as an emerging safety concern in patients taking selective serotonin reuptake inhibitor (SSRI) antidepressants, including fluoxetine (PROZAC) and paroxetine (PAXIL).

The Food and Drug Administration (FDA) has not yet required that this information be included in the Medication Guides for patients that must be dispensed with all of these drugs. The current Medication Guides warn about the possibility of increased suicidality and withdrawal reactions when suddenly stopping the drugs but have not been updated since 2007.