FDA is Requiring Chantix and Zyban to Carry Depression Warning
The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effect. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA. According to Pfizer, Inc. officials, the study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side effects.
Pfizer has previously updated it labeling after an FDA investigation into potential side effects in 2007. That investigation was sparked by several reports of psychiatric problems in patients. However, despite the new, stricter warnings, the FDA said consumers and doctors still have to weight the benefit versus the risks when taking these drugs.
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