FDA to Run a Second Safety Review on Chantix

By Anna Boyd
14:45, June 2nd 2008
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FDA to Run a Second Safety Review on Chantix

Following the negative publicity surrounding Chantix lately, the U.S. Food and Drug Administration decided to run another safety review of the drug.

This would be a second time when the federal agency makes such an investigation after the first, undergone in February, revealed an association between Chantix and serious neuropsychiatric symptoms. At the time, the FDA requested that Pfizer elevate the prominence of this safety information to the warnings and precautions section of Chantix prescribing information or labeling.

As if this wasn’t enough, last week, a report by the Institute for Safe Medication Practices, a non-profit watchdog group warned against “use of Chantix among persons operating aircrafts, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.”

The report linked Chantix to 224 cases of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. Also, there were 173 serious injuries, some resulting from traffic accidents where drivers on Chatix treatment were dizzy, mentally confused or became unconscious.

These findings prompted the Federal Aviation Administration and the Federal Motor Carrier Safety Administration to ban Chantix’ use by their pilots, air controllers and truckers.

Also, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said the agency is reviewing all the reported cases, but this will take time, Reuters reports. Until then, patients using Chantix are urged to stop taking it and to immediately call their health care providers if they experience agitation, depression, behavior changes or suicidal thoughts.

Meanwhile, Pfizer decided to launch a nationwide campaign consisting in ads in the country’s five largest newspapers to save Chantix.

The company also plans to send letters to 300,000 health-care providers and to organize conferences with reporters. Moreover, television commercials are scheduled to run in June emphasizing the importance of smoking cessation, without recommending or mentioning Chantix.

 



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