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Pfizer Accused of Under-Reporting Side Effects of Stop-Smoking Drug

Brand X Pictures/Thinkstock(WASHINGTON) -- Everyone knows smoking cigarettes can kill you, but so might drugs that are supposed to help you kick the habit.

While severe side effects from the smoking-cessation drug Chantix have been documented for years, it turns out that suicides resulting from using the product made by Pfizer Inc. were actually more than twice in number than the pharmaceutical company admitted.

It's all there in a new analysis by the Institute for Safe Medication Practices (ISMP), which says that there were 150 instances of Chantix users taking their lives out of the nearly 600 delayed reports of severe issues noted in the study.

The Food and Drug Administration contends that Pfizer covered up the actual number of suicides by submitting information through "improper channels."  As a result, the FDA wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts.

One ISMP scientist said of the data, "It’s really chilling.  This seems to unleash something in people.  It can be violence to anything around.  We’ve had a major breakdown in safety surveillance."

While Pfizer says it will comply with the FDA request, the company contends there's no concrete evidence Chantix causes suicides.

Last year, the drug was prescribed 3.2 million times worldwide.

Copyright 2011 ABC News Radio

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