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FDA Warns Non-Smoking Drugs Cause Depression

Posted on: Wednesday, 1 July 2009, 16:32 CDT

The Food and Drug Administration is tightening up on smoking cessation drugs, Chantix and Zyban, by requiring the drugs to be labeled with safety warnings over side effects including depression and suicidal thoughts.

New regulations are based on reports of people experiencing depression or having suicidal thoughts while using the drug.

The FDA is also requiring a study on Chantix and Zyban to fully understand the side effects of the drugs.

Pfizer Inc., which makes Chantix, already has been labeling potential side effects after an investigation by the FDA in 2007 found several reports of psychiatric problems in patients using the drug.

The FDA said that consumers and doctors still should weigh the benefit against the risk from taking the drug, despite the new warnings.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit."

Also, the FDA began looking at scores last fall of patients that reported to have blackouts and injuries when taking Chantix.  The Federal Aviation Administration banned Chantix from being used by Pilots and air traffic controllers after those reports.  The drug's label advises people not to use Chantix while operating heavy machinery.

In 2006 the FDA approved Chantix and by 2008 its sales rose to $846 million.

"The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer.

Pfizer said that it is adapting to the new FDA label warning requirements and is immediately making the information available to health care providers and patients.

According to its website, Chantix works by blocking the nicotine from reaching the nicotine receptors in the brain.
 
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On the Net:

• FDA
• Chantix

Source: redOrbit Staff & Wire Reports

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