FDA: Chantix must carry mental health warning - Article
Posted Jul 01 2009 4:30pm
FDA: Chantix must carry mental health warning Smoking cessation drug now required to warn of depression, suicide risks
The Food and Drug Administration will require Pfizer Inc.'s smoking cessation drug Chantix to carry the agency's strongest safety warning over a series of mental health side effects, including depression and suicidal thoughts.
The new requirement is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drug.
Pfizer Inc. had already updated the drug's labeling, following the beginning of an FDA investigation into the potential side effects in 2007.
The FDA is also requiring an additional study on the drugs to determine the extent of the side effects.