Chantix side-effects news prompts FAA ban

Chantix suffered a one-two punch yesterday, as a watchdog group's report linked the stop-smoking med to a wide variety of health and safety problems, and the Federal Aviation Administration told pilots and air traffic controllers not to use it. The FAA's decision directly affects only 150 pilots and 30 air traffic controllers known to be taking the drug, but it could lead to bans by other transportation agencies.

Potentially more damaging is the Institute for Safe Medication Practices' report, which analyzed the hundreds of adverse events reported to the FDA. More than 200 reports of suicide attempts or suicides, almost 400 of possible psychosis, and 525 of hostility or aggression were sent to the agency between May 2006 and December 2007. (Putting this in perspective, an estimated 6.5 million people have used the drug.)

Okay, we've known about Chantix's link to psychiatric side effects for some time; the FDA asked Pfizer to add warning language to the drug's label. And the Institute allowed that the number of reports might have been spurred upward by publicity surrounding a Dallas musician's bizarre behavior on Chantix. But nevertheless, the report said, Chantix's risks have been underestimated. The study's lead author called on Pfizer and the FDA to "immediately" strengthen warnings on Chantix's label and launch careful studies of the safety issues.

The new report also linked Chantix to other side effects: accidents and falls, potentially lethal heart rhythm problems, heart attacks, seizures, and diabetes. Rattled by the data--and by recent prescription trends, which have been decidedly downward--Wall Street analysts cut their sales forecasts for Chantix. Year over year, Chantix scrips have dropped 30 percent, and if they continue falling at that pace, "forecasts for Chantix could be too high by as much as $500 million to $1 billion by 2012," a Sanford Bernstein analyst wrote. That firm, for one, is cutting its 2008 forecasts--to $909 million in global sales from $1.14 billion--and 2012 numbers to $700 million from $1.6 million. For 2007, Chantix sales were $883 million.

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