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FDA May Strengthen Chantix Label

Anti-smoking drug linked to more seizures, accidents

By Ambreen Ali,  Newser User

Posted Oct 22, 2008 5:25 PM CDT

(Newser) – The FDA may beef up its warning for the anti-smoking drug Chantix after an increase in the number of serious incidents linked to the drug, the Wall Street Journal reports. A drug-safety group tallied 1,001 reports of patients suffering seizures, blackouts, and loss of motor control—some while driving—in three months. The figure is more than the combined total of incidents linked to the top 10 prescription drugs.

Pfizer says it will “stand by the efficacy and safety” of Chantix. It claims the reports are “unverifiable and lack sufficient medical information to draw any conclusions," and that nicotine withdrawal could be the culprit instead. The FDA already is reviewing Chantix for links to depression and suicidal behavior. Once nearing $1 billion in annual sales, Chantix sales stopped short of $100 million last quarter.

Margaret Bastian says she had problems with the drug Chantix.
Margaret Bastian says she had problems with the drug Chantix.   (AP Photo/David Duprey)
Chantix promised a pleasure pathway for quitters, but has been linked to depression and serious injuries.
Chantix promised a pleasure pathway for quitters, but has been linked to depression and serious injuries.   (Flickr)
Pfizer dismisses the report and says it will stand by the efficacy and safety profile of Chantix.
Pfizer dismisses the report and says it will "stand by the efficacy and safety profile of Chantix."   (AP Photo/Mary Altaffer)
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