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FDA requires boxed warning describing risk of serious mental health events with use of smoking-cessation treatments Chantix, Zyban, generic versions
Wednesday, July 01 2009 | Comments
What's This?
The Food and Drug Administration is requiring Pfizer Inc. and GlaxoSmithKline Plc (GSK) to add a boxed warning to their respective smoking-cessation treatments, Chantix (varenicline tartrate) and Zyban (bupropion hydrochloride), indicating an increased risk of serious mental health events, such as changes in behavior, depressed mood, hostility and suicidal thoughts, when using these drugs.Bupropion is also marketed by GSK as Wellbutrin for the treatment of depression, and the compound is available in generic versions. In May, GSK announced that it was selling the U.S. rights to Wellbutrin XL for $510 million to Biovail Laboratories International SRL, a subsidiary of Biovail Corp., pending regulatory clearance.
The FDA said all formulations of bupropion must include the new warning, although the agency noted that these drugs already carry a boxed warning for suicidal behavior in treating psychiatric disorders.
The FDA's analysis was based on data from its Adverse Event Reporting System and on information from clinical trials and scientific literature indicating that patients treated with Chantix or Zyban have reported experiencing unusual changes in behavior, becoming depressed or having their depression worsen and having thoughts of suicide or dying.
However, neither of these drugs contains nicotine, and smoking cessation can be associated with symptoms of nicotine withdrawal, such as depression, anxiety, irritability, restlessness and sleep disturbances, the agency noted. But some of the reports of mental health adverse events occurred in patients who continued to smoke.
The FDA also is requiring the manufacturers to conduct a clinical trial to evaluate how often serious neuropsychiatric symptoms occur in patients using various smoking-cessation therapies, including patients who already have psychiatric disorders.
Pfizer said it updated the Chantix label to reflect the reports of serious neuropsychiatric events. Dr. Briggs Morrison, a senior vice president at Pfizer, added that the benefits of Chantix outweigh the risks for many patients when used as directed. The company noted that it is conducting clinical trials of Chantix in a number of patient populations, including among individuals with psychiatric disorders and chronic lung disease.
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