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Anti-Smoking Drugs Get FDA 'Black-Box' Warning
Date:7/1/2009

y, irritability, restlessness, and sleep disturbances, the FDA noted.

Some patients who were using the drugs experienced the side effects while they were still smoking, the agency said.

Rosebraugh said the risk of using these drugs needs to be balanced with the substantial benefits of quitting smoking, and these drugs can be very effective.

"Stopping smoking is a goal we all want to work towards, and if people need medication to do it they should have access to it. So we don't want to scare people off from trying to use a medication to stop smoking; we just want them to be carefully monitored," he said.

In addition to the warning, the FDA is requesting more prescribing information in the warning section of the label, and new information in the Medication Guide for patients that discusses the risk of mental health events while using these products.

The makers of the drugs will also be required to do a clinical trial to see how often serious psychiatric symptoms occur in patients using a variety of therapies to help them quit smoking, including patients who currently have psychiatric disorders, Rosebraugh said. Results of this trial won't be known for several years, he added.

Chantix is manufactured by Pfizer Inc. Zyban is made by GlaxoSmithKline.

"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," Dr. Briggs W. Morrison, senior vice president for the Primary Care Development Group at Pfizer, said in a prepared statement. "Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex."

The FDA's review of consumers using nicotine patches did not find a link between patches and psychiatric side effects.

The antidepressant Wellbutrin
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