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Chantix Nixed for Pilots; Caution for Truckers, Bus Drivers

Government Officials Eye Safety of Quit-Smoking Drug Chantix

Chantix Decisions continued...

Is that decision permanent? "It's hard to say," says Dorr. "We're always open to new data. ... We would have to have some really good data that showed something to the contrary in order to make it acceptable again, and that's probably not going to happen."

The FMCSA hasn't banned Chantix for truckers or bus drivers. In a statement emailed to WebMD, the FMCSA says it defers to doctors and health care professionals to determine drivers' medical fitness for duty, including the possible impact of medication use.

FMCSA regulations don't single out medications. But the FMCSA states that "it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver's ability to safely operate a commercial motor vehicle."

FDA Weighs In

The FDA approved Chantix in May 2006.

In November 2007, the FDA announced that it was investigating reports of suicidal thinking, aggressive and erratic behavior, and drowsiness in people taking Chantix. At the time, the FDA advised patients to use caution when driving or operating machinery until they knew how Chantix may affect them. The FDA also stressed that it didn't yet know if Chantix was responsible for those problems.

In February 2008, FDA officials noted that they have received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides in people taking Chantix. Those reports don't prove that Chantix was to blame for suicidal thinking, behaviors, or suicides. The FDA warned people taking Chantix that they might have trouble driving or operating heavy machinery.

The ISMP's new study hasn't been published in a peer-reviewed journal.

"We actually chose to go ahead and publish it in our newsletter and offer it online because it can take so long to get into a peer-reviewed publication," Renee Brehio, ISMP public relations manager, tells WebMD. "ISMP really felt strongly that this was a crucial enough safety issue that we didn't want there to be that lag time between the findings and getting it published."

The ISMP report doesn't analyze the FDA's raw data on reported adverse events, notes Woodcock. The FDA has been investigating those reports. "We've also been considering what further studies could be done to evaluate them," says Woodcock.

Meanwhile, the FDA asks doctors and patients to report adverse events from Chantix -- or any other drug -- to the FDA's MedWatch program.



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