Anti-Smoking Drug Banned By FAA

Pilots And Air Traffic Controllers Prohibited From Using Chantix After Negative Report

(AP)  Pfizer Inc.'s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers.

The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.

"We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury," the researchers said in the report.

FAA spokesman Les Dorr said the Chantix ban is effective immediately and that the agency was notifying unions representing pilots and controllers. He said the FAA is unaware of any aviation accident caused or contributed to by Chantix.

Pfizer, in a statement, reaffirmed its stand on the drug's safety and said the label already contains safety warnings about driving or operating machinery.

"It is important to understand the limitations of spontaneous adverse event reporting," the company said. "Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality."

The report specifically cites 173 serious events described as accidental injuries, including 28 road accidents and 77 falls. There were also 68 cases of blurred vision, 86 cases involving seizures and 372 reports of movement disorders. The researchers recommended the Food and Drug Administration undertake an epidemiological study to assess potential risks.

The regulatory agency has been under fire for its lack of post-approval tracking of prescription drugs, following several drug safety issues.

Congress last year gave the FDA the authority to order drug label changes and conduct more safety studies after several medicines, including Merck & Co.'s blockbuster Vioxx, were pulled from the market because of their safety risks.

The Institute for Safe Medication Practices' report and Wednesday's move by the FAA come months after the FDA said the connection between Chantix and serious psychiatric problems is "increasingly likely." Pfizer had already added stronger warnings to the drug's label before that opinion was released in February.

New guidelines released this month by the U.S. Public Health Service recommend doctors prescribe the drug to help smokers quit. The new guidelines mention links to depression and suicidal behavior but also say the popular drug is the most effective at helping people get off cigarettes.

Chantix sales totaled $277 million during the first three months of 2008, an increase of 71 percent from a year earlier. For full-year 2007, the drug had sales of $883 million.

[bluescoot47]

What does the FAA have to do with this??

[redbds]

I just hit two weeks using chantix and not smoking. No side effects other than a little trouble sleeping. It is well worth it to loose a little sleep if I can kick this nasty habbit.

[jt92202]

Almost at my 1 year of not smoking, no side effects and very happy I used it to quit smoking.

[rf35]

Risk vs. benefit to the PATIENT, that is, not benefit to the doctor. I understand "incentives" for the prescriber are common in the civilian medical world.

[leisurejack1]

This just shows a complete lack of understanding of how to do research or understand statistics. Take the case of suicide rates for Chantix. In the US the rate of suicide is 11 per 100,000 people. In the case of this drug it is 227 attempts per 6,500,000 users, which breaks down to 3.49 per 100,000. If you look at the number of suicides for the drug it is 28 for the 6,500,000 or 0.43 per 100,000. This is fear mongering at its best.

[rf35]

After several unsuccessful attempts at quitting smoking, I finally got it done with Chantix. I offer that doctors with nothing to gain (military docs don''t get "favors" from drug cos) will prescribe using the risks vs. benefits analysis. The US surgeon general and various private orgs have gone on for years about how deadly smoking is, yet when a product comes along that actually helps beat the physical nicotine addiction and the psychological addiction to the act of smoking, someone cries "foul!" Ask yourself this: would you rather breathe my second-hand smoke or let me take the Chantix and not bother you. Maybe pilots shouldn''t take Chantix, but then they shouldn''t take most antihistamines either, should they? I, for one, have experienced only mild side effects like nausea if I take it without eating first and a slight case of euphoria the first two days. Both were expected and warned about. It boils down to this: if Chantix helps millions of people stop smoking and 100 have an adverse reaction, then it is a good thing. Another way to think of it is you could keep shelling out your tax and health insurance money to pay for smoking-related illness or support a treatment that saves you money. Don%u2019t be so short-sighted and condemn everything that Big Pharma offers just because THEY offer it...once in a while, they get something right.
P.S. If you%u2019ve ever read any of my posts on earlier articles, you know I%u2019m not shill or a fan of drug cos in general.

[tootall10142]

my doctor is head of nuero surgery in a major hospitalinmy city .He warned me against any synthetic drug,saying that it will take three years to see any infant effects and may take ten years to have a definite mortality rate.If you lived this long without them you can live longer ignoring them.

[excoachken]

"Citing a study done with funding provided by The National Tobacco Institute."

[docpeter-2009]

From the story, "It is important to understand the limitations of spontaneous adverse event reporting," the company said. "Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality."

In other words, even if this drug did have serious side effects we will do our best to deny causality.

In regard to torti151''s comment about using this drug to quit smoking, congratulations. From other news reports it has been tied to serious depression and suicide, especially when combined with alcohol use, from what I understand.

In regard to maxif55, while your comment MAY have merit on the outside, a pilot flying at 36,000 ft with 290 passengers on board shouldn''t be having any of the side effects occurring while in flight. There is more at stake than his/her personal safety.

[torti151]

Thanks to Chantix, I stopped smoking 14 months ago. No side effects that I can recall.

This follows a familiar scenario. Tremendous profits but dogged by side effects. Maybe synthetic drugs are not the answer. It puts profits ahead of safety.