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Chantix Grounded by Federal Aviation Administration

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Washington, DCIt still might be okay for YOU to use the anti-smoking drug Chantix in spite of all the warnings over suicidal thoughts and potential psychosis, but as of Wednesday pilots and air traffic controllers are no longer allowed to use the drug. The Federal Aviation Administration (FAA) has just banned the use of Chantix for pilots and air traffic controllers, fearing for the safety of passengers.

Plane FlyingChantix, the smoking-cessation drug once considered to be a blockbuster, has lost a lot of its luster since last September after news began to surface of bizarre behavior and serious adverse reactions. The most serious, of course, have been an increasing number of reports of suicides and suicide attempts. Public Citizen, a consumer advocacy group founded by Ralph Nader, has long called for a black box warning for Chantix, which is marketed as Champix in Canada and overseas. And the US Food and Drug Administration (FDA), has been conducting a safety review of Chantix ever since it released a public health alert back in February.

However, it has been the findings of yet another medical watchdog group, the Institute for Safe Medication Practices (ISMP) that appears to have caught the attention of the FAA.

Those findings suggest that from May 2006 until December 2007 there were 227 reports of suicide attempts or actual suicides, 397 cases of possible psychosis and 525 reports of hostility or aggression. The latter is what led to the death of popular Dallas musician Carter Albrecht, after he flipped out one night, assaulted his girlfriend and attempted to break into a neighbor's home before being shot dead by the startled occupants.

Specifically, there have been 28 suicides reported, together with 41 mentions of homicidal thoughts, 60 cases of paranoia and 55 instances of hallucinations.

The FAA, as a result, no longer wants to face the risk of similar behaviors on the part of pilots and air traffic controllers. Those functions are high-stress and of optimum importance to the safety of passengers, and ultimately to the safety of the skies. Thus, the federal aviation authority has decreed that 150 pilots and 30 air traffic controllers currently taking Chantix, must immediately come off of it, and people in those jobs will no longer be allowed to go anywhere near Chantix.

It is the most telling example yet of the concern over varenicline, the active ingredient in Chantix, made by Pfizer, that works by targeting receptors in the brain, undertaking a delicate balance of blocking the nicotine that results in the release of dopamine, the chemical that lies at the basis of the smoker's high felt with every puff.

While Chantix was shown in clinical trials to be an effective tool in the war against smoking, the medical community is now wondering if the full impact of varenicline has yet to be understood. And while Chantix was shown to work better than Zyban, its closest rival, most of the participants who attempted to quit using Chantix went back to smoking—this, in spite of professional counseling that served as a valued hand to hold for participants in the trial. In the real world, that hand is often not there.

The ISMP findings were derived from expert analysis of adverse events reported to the FDA. The Institute's reports link Chantix to a wide variety of health and safety concerns, including accidents and falls, potentially lethal heart rhythm disturbances, heart attacks, seizures, diabetes and the aforementioned psychiatric disturbances.

Pfizer defended its product in a statement Wednesday, stressing that current labeling for Chantix aptly reflects the product's safety profile, citing the potential for psychiatric problems, and possible impairment of driving.

The company's stock took a hit at the news Wednesday, falling 22 cents to close at $19.79 per share, a drop of 1.1 per cent. An estimated 6.5 million people have turned to Chantix in an attempt to quit smoking. That effort was worth $883 million in worldwide sales for Chantix last year. It should be noted that by 2012 sales of Chantix were originally forecast to hit $1.6 billion. However, after Wednesday's report that forecast was sharply downgraded, as reported this morning in the New York Times by Dr. Timothy Anderson, a pharmaceutical analyst for Sanford C. Bernstein & Company. Expections are now lowered for Chantix to $700 million in sales four years from now—less than half what had been originally forecast.

The FDA has been on the Chantix watch since November of last year. It will be interesting to gauge how the agency responds to this latest development. For now, the FDA requires careful prescribing of Chantix on the part of doctors, and mandates pharmacists to distribute a medication guide to patients. While the FDA safety review is an ongoing process, so far there has been no black box warning, or outright ban related to the product, a suggestion that the FDA has yet to determine that the risks of Chantix outweigh the benefits.

However, that decision has been made for pilots and air traffic controllers by the Federal Aviation Administration, which is set to notify all associations, representing commercial and private pilots that Chantix is no longer allowed, either in the air or on the ground.

The bottom line is that it may be okay for you to take Chantix. But not for pilots or air traffic controllers.

It's a telling development that shifts an even greater focus on the FDA, to see what it does next. In the meantime, smokers harmed by Chantix continue to line up for their turn in court…



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