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Friday, May 23, 2008

More on problems with smoking and stop smoking drug Chantix

Since the most recent post on this topic, new warnings now out for Chantix and truckers.

See also this post from February 02, 2008, "More on the dangers of Chantix"

Trucking regulators warn against Chantix

Published: May 23, 2008 at 12:54 PM

WASHINGTON, May 23 (UPI) -- U.S. federal trucking regulators have advised medical examiners not to qualify anyone using Chantix, an anti-smoking drug linked to possible health issues.

The Federal Motor Carrier Safety Administration is the latest regulator to warn against certifying people using the smoking cessation aid. The Federal Administration banned the drug for pilots and air traffic controllers after a study linked Chantix to seizures, dizziness, heart irregularities and diabetes.

In its warning issued Thursday the FMCSA advised medical examiners "to not qualify anyone currently using this medication for commercial motor vehicle licenses," The Wall Street Journal reported Friday. The FMCSA oversees the interstate trucking and bus industry.

A U.S. Food and Drug Administration spokeswoman said the agency was focusing on likely links between Chantix and neuropsychiatric side effects. This year, the FDA and Pfizer, which manufactures the drug, updated warnings on Chantix's label to include depression and thoughts of suicide.

The Institute for Safe Medication Practices, a non-profit watchdog group in Horsham, Pa., conducted the Chantix study that reported the drug was linked to more than 900 serious episodes in the last quarter of 2007.

Pfizer said the report's findings weren't inconsistent with possible side effects listed on drug's label.

© 2008 United Press International.

I grew up in a home where both parents smoked for many years, my father stopping only when I was in my teens. My mother continued to smoke until she was in her 90s, and did so only after a closed head injury placed her in someone else's care. She always smoked Philip Morris.

Influenced by this, as probably my asthma as a child was, and differences in social norms at the time, I was a very light smoker of brands like Gauloise and Camel straights. But them I am sort of known as one "gutsy babe". Maybe it was an intellectuals thing too.

I quit smoking many decades ago, by the pure and simple cold turkey method. At that time we were not overloaded with ads for drugs, patches, other Rx, dial up support lines or web sites offering counseling to help us quit.

I do know the risks and hazards of smoking, and second hand smoke. I also know it does not seem to bother all people, my mother being an example.

In one instance it caused a great amount of harm to a dear friend of mine. I tried for years to encourage her to stop smoking. She always had a reason why she couldn't until she was diagnosed with congestive heart failure. I saw the report from her workup along with labs and other relevant data. It was scary to me and I really wondered how she made it day by day.

At last she has quit smoking. And she is very glad she did.

She used nicotine patches. She was worried about another friend we have that used Chantix.

A popular series of articles on this blog are ones I posted late in 2007 and early 2008 about the risks of Chantix as an aid to stopping smoking.

Now today we find out more.

In years passed airline pilots were banned from using any products with aspartame because it is known to cause seizure or other reactions that could put passengers and crew at risk.

Today the FAA has banned the use of Chantix by pilots and flight controllers.

If you are considering stopping the use of tobacco, including chew, you might want to consider that Chantix is not something you want to use in your plan.

Help in this process is something we have done for many years, using the natural approach. Contact us to find out more.

Varenicline (Chantix) Off the Table for Pilots and Controllers
By Marianne Mattera, Managing Editor, MedPage Today
Published: May 21, 2008
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

WASHINGTON, May 21 -- Citing "a wide range of issues," the Federal Aviation Administration has barred pilots and air traffic controllers from using the smoking cessation drug varenicline (Chantix).

A spokesperson said the agency would be sending a letter detailing the decision to the Aircraft Owners and Pilots Association, the Air Line Pilots Association, and those it knows to be taking the drug, including 150 pilots and 30 controllers.

The letter will advise recipients to stop taking the drug immediately, and it prohibits them from work for 72 hours after the last dose.

The FAA action was taken following a report from the Institute for Safe Medication Practices, a drug watchdog group. The group reported that in the fourth quarter of 2007, varenicline was implicated in 988 events reported to the FDA. These included serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression, and suicide.

In February, the FDA confirmed 39 suicides among persons using varenicline.

Overall the FDA said it had 420 confirmed reports of mood changes, including anxiety, nervousness, depressed mood, tension, and suicidal behavior or suicidal thoughts.

At the same time, the FDA reiterated its stance that the drug was an effective smoking-cessation agent, but indicated that the agency is continuing its review of the drug.

The FDA said that Pfizer, which makes varenicline, estimated that about five million people have used the drug since it was approved in May 2006, suggesting that the event rate was low (See: FDA Approves Smoking-Cessation Drug).

In January, Pfizer changed the drug's label to reflect the FDA alert.

The FDA said physicians should carefully monitor patients for behavioral and mood changes and warned that persons using the drug should immediately report such symptoms to their physicians.

Varenicline works by partially blocking the alpha4-beta2 nicotinic receptor in the brain, which is the brain's main nicotine receptor. Within 10 to 19 seconds of a single puff from a cigarette, nicotine attaches to this receptor. The receptor, in turn, triggers large increases in dopamine, which rewards the smoker with a pleasurable sensation.

Pfizer could not be reached for comment on the FAA action.

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