Zug.com, a reader-powered comedy website, announced a contest it is holding for the most hilarious Chantix story. The person who submits the funniest account of his or her Chantix side effects will win $500.00 — enough money for another 5 months of prescriptions.

As bizarre as the contest sounds, Zug.com isn’t joking.

“We looked at all those side effects and we thought: pure comedy,” said ZUG.com editor-in-chief Sir John Hargrave in a statement. “In the bizarre dreams category alone, there’s just incredible humor potential for our site.”

A webpage for the contest, which runs through November 2008, asks, “Have you tried Chantix? Did you experience weird dreams, strange side effects, or violent mood swings? Write up your funniest description of the weird dreams or bizarre side effects of quitting smoking on Chantix, then submit them …”

It should be interesting to see how this contest is received by the public. Chantix was linked to more reports of adverse reactions and death than any other drug in the first two quarters of 2008. Controversy continues to escalate and broaden as the drug’s safety comes under close scrutiny by the Food and Drug Administration and is prohibited or banned outright by some government and professional organizations.

Irreverence is often a big part of comedy. The ability to laugh at one’s self is tantamount to (and nobler than) laughing at others. Still, though, it seems like there may be a line here that has been stepped on, if not crossed. Can Chantix reactions really provide fodder for the comedy mill? Are the side effects really a laughing matter?

SOURCE: Chantix Recall › Are Chantix reactions a laughing matter?

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.

“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.

Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.

“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,” FMCSA Administrator John H. Hill said in a public statement.

Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.

Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.

SOURCE: Chantix Recall › Researchers recommend new Chantix warnings

Thomas J. Moore, an independent researcher who analyzed the safety of Chantix for the FDA, told the Associated Press that he was particularly concerned about the non-psychiatric side effects Chantix has on some users. These effects include vision problems, disturbances of heart rhythm, seizures, skin reactions, aggression, and loss of consciousness, among others. In themselves, some of these side effects aren’t deadly. However, when they occur within the context of driving or operating heavy equipment, they may be very harmful, if not fatal.

A study of “adverse events” reports conducted by the Institute for Safe Medication Practices contained the following warning:

“We have immediate safety concerns about the use of [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.”

In May, the Federal Aviation Administration (FAA) banned pilots and air traffic controllers from using Chantix. In August, the Federal Motor Carrier Safety Administration prohibited the use of Chantix without naming the drug specifically.

Late last year, Chantix claimed first place on a list of drugs with the most reported side-effect related problems. Traffic accidents ranked second in Chantix-related injuries, with 28 accidents directly attributed to use of the drug. Loss of consciousness, dizziness, confusion, and muscle spasms were the causes cited.

It’s important to keep these warnings in mind if you use Chantix and drive. Stay focused and alert; if you feel confused or dizzy, pull over immediately because the safety of you, your passengers, and everyone around you may be in jeopardy.

SOURCE: Chantix Recall › Chantix played role in traffic accidents

In a statement issued May 23 by Administrator John H. Hill, he would not go so far as to specifically prohibit the use of Chantix for interstate truck and bus drivers, saying the FMCSA would not “name any medications, such as Chantix, in FMCSA regulations.”

However, the FMCSA does prohibit the use of prescribed substances or drugs that adversely affect the driver’s ability to safely operate a commercial vehicle, and said “it appears that medical examiners should NOT certify a driver taking Chantix,” because the medication may do just that.

The FDA advisory on Chantix (varenicline) indicated that patients taking the popular stop-smoking medication are at risk for serious neurpsychiatric symptoms that may include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.

Hill stopped short of issuing an outright ban on Chantix, saying FMCSA’s rules “defer to the physicians and health care professionals to determine driver medical fitness for duty.”

The Federal Aviation Administration firmly banned Chantix for use by either pilots or air traffic controllers in May following the FDA’s public health advisory announcement.

While the drug is not officially banned by name, Land Line Magazine, the official publication of the Owner-Operator Independent Drivers Association (OOIDA), said in its August issue that medical certification of truckers using Chantix is “not likely.”

SOURCE: Chantix Recall › FMCSA stops short of Chantix ban

Chantix, manufactured by Pfizer, was approved in 2006 and since that time has been prescribed to more than 4 million patients. However, not long after its release, the drug was linked to psychiatric problems including depression, suicidal thoughts and actions, and aggressive behavior. The drug also has been linked to serious physical side effects including heart problems, diabetes and serious allergic reactions such as Stevens Johnson Syndrome.

According to the Stars & Stripes, the drug was removed from the military pharmacy at Yokota Air Base in Japan. The decision came after a May 21 report by the Institute for Safe Medication Practices, which says Chantix has had more serious adverse incident reports in the fourth quarter of 2008 than any other drug in this time period.

In response to the ISMP report, the Federal Aviation Administration banned pilots and air traffic controllers from using the drug. The Stars & Stripes reports that the Defense Department’s Office of the Chief Medical Officer also recommended that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

The paper says the DOD safety notice also had recommendations for “vehicle operators, operational personnel, and other DOD personnel” under consideration.

Stars & Stripes says the Yokota base has not reported any adverse reactions to Chantix, but seems to be banning the drug as a precautionary measure, and has suspended refills of Chantix until patients review the drug use with their physician. Other base hospitals overseas have not banned the drug, but air crewmembers cannot take the drug, and other Chantix patients are required to discuss their use of the product with their physician. Pharmacies can special-order the drug based on those prescriptions.

According to the report, when Chantix was first licensed in 2006, it was prescribed 262 times in military treatment facilities. By fiscal year 2007, there were 67,580 prescriptions written for Chantix in military facilities.

SOURCE: Chantix Recall › Military pharmacy pulls Chantix