May 21 (Bloomberg) — Pfizer Inc.’s stop-smoking pill Chantix has been linked to more than 3,000 reports in the U.S. of serious side effects, including suicides, heart trouble and aggression, a study said.

U.S. regulators should tighten warnings on the pill, prescribed 3.5 million times in the U.S. since it was approved in 2006, the nonprofit Institute for Safe Medication Practices said in its report. The group analyzed side effects reported to the Food and Drug Administration. The Federal Aviation Administration today banned the use of Chantix by pilots because of the report, spokesman Les Dorr said.

The FDA received more accounts of serious side effects tied to Chantix in the fourth quarter than from any other drug, the analysis found. In January, the agency said the drug may cause suicidal behavior and mood changes. The warnings need to say the medication shouldn’t be used while driving, piloting airplanes or operating machinery because it may cause unconsciousness, seizures and hallucinations, the report said.

“These data provide a strong signal that the risks’ of Chantix “have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers,’ the Horsham, Pennsylvania-based Institute said in its report.

Pfizer, based in New York, fell 1.4 percent to $19.73 in extended trading after the close of the New York Stock Exchange, after dropping 27 percent in the previous 12 months.

Among the psychological side effects reported to the FDA were 28 suicides, 41 cases of homicidal thinking, 224 reports of heart trouble, 525 reports of hostility or aggression, and 397 cases of possible psychosis. There were also 173 serious injuries, including traffic accidents often associated with unconsciousness, dizziness, muscle spasms, or mental confusion.

There were also reports of severe skin conditions and new cases of diabetes in patients.



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