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This week saw a blitz of media coverage on pharmaceutical firm Pfizer's "wonder drug," Chantix. The gist of it all? Good news and bad news: The good news is that Chantix has shown to be effective in the curbing of desire to smoke cigarettes; the bad news is your long-term health may come at the cost of much shorter lifespan. If you drive, that is.
First came the release of a report from non-profit organization The Institute for Safe Medication Practices, which declared that "A strong signal of multiple safety problems with Chantix (varenicline), a drug to help people stop smoking, has been seen in a pilot program ... Varenicline is suspected in various adverse drug event reports of causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide."
The study itself was prompted by some alarming numbers reported earlier this year, showing that some 988 serious injuries reported to the FDA in the US in the fourth quarter of 2007 alone could be attributed to varenicline, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury for 769 different drugs in the fourth quarter."
The FDA has issued a Public Health Advisory on the drug, and the FAA followed on Wednesday in stating that varenicline was no longer considered safe for airplane pilots or air-traffic controllers, noting that the drug "may lead safety problems during flight."
On Thursday, the Federal Motor Carrier Safety Administration "advised" medical examiners "to not qualify anyone currently using this medication for commercial motor vehicle licenses." The FMCSA believes that varenicline could be responsible for some 100 road accidents
And from the Real-Life Horror Movie Department, the Sunday edition of the Los Angeles Times writes of the harrowing tale of one varenincline user:
[Daniel Williams] started taking the medication, and a couple of nights later, as he was driving his pickup truck on a country road in Louisiana, Williams suddenly swerved left.
His girlfriend, Melinda Lofton, who was with him, later told him that his eyes had rolled back in his head and that it had seemed as if he was frozen at the wheel, accelerating.
Moments later, they were in a bayou, struggling to escape the murky water, Williams said.
Naturally, Pfizer's party line on varenicline tells a different tale, with the company's official double-negative employing statement to the effect of "the report's findings were not inconsistent with possible side effects already listed on Chantix's label." Pfizer senior medical director Martin Flammer meanwhile stated flatly that "This is not any new data," and that "It's not clear whether problems in Chantix users are due to the drug, nicotine withdrawal or neither."
Good luck on your next flight, then, Mr. Flammer. No real risk at all...
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