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FDA schedules meeting to review Chantix

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On Friday, the Food and Drug Administration announced that a group of psychiatric drug experts are scheduled to meet in October to review the smoking cessation drug Chantix and its side effects.

Since 2009, Chantix has carried the strongest warning label issued by the government. Pfizer, the drug company that makes Chantix, was required to place the so-called “black box” warning label after hundreds of reports about suicidal behavior were received by the FDA.

Indeed, there were dozens of other reports the agency received about actual suicides committed by people taking the anti-smoking drug. Chantix has a side effect profile that includes the risk of agitation, depression, hostility and suicidal thoughts.

Pfizer includes a warning on the label that tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes.

The company also advises doctors to compare the risks of Chantix to its benefits before prescribing the drug to help patients quit smoking.

Recently, Pfizer submitted new data to the FDA that compared the drug's safety to placebo and other anti-smoking techniques, a spokesperson for the drug company said Friday.



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