Anti-smoking drugs (non-nicotine) - Chantix and Zyban to carry mental health warnings..

July 2, 2009 - The FDA said Pfizer Inc's Chantix (Champix, varenicline) and GlaxoSmithKline's (GSK) Zyban will carry the labeling warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs.

The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor.

The agency also is requiring Pfizer Inc. and GSK to conduct a study looking at how often these serious symptoms occur. The FDA says that since Chantix was approved in 2006, the agency has had reports of 98 suicides and 188 attempted suicides. Zyban has had reports of 14 suicides and 17 attempts.

Zyban contains the same active ingredient as the antidepressant Wellbutrin and already carried a box warning about the increased risk of suicidal thinking and behavior.

Reference: Two anti-smoking drugs to carry mental-health warnings by Saundra Young, CNN, 7/1/2009.

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