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What's Next For Chantix?

Posted by Jane Akre
Tuesday, May 27, 2008 7:13 PM EST
Category: On The Road, Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Chantix, Smoking, Drug Products, Defective Products, Motor Vehicle Accidents

Chantix to get a closer review by the FDA. 

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IMAGE SOURCE: Pfizer, Chantix ad

 

The smoking cessation drug, Chantix has been in the news lately and for all the wrong reasons, and now the Food and Drug Administration is taking a closer look  at the drug and its side effects.

Pfizer makes Chantix which has been linked to hundreds of reported cases of problems among them, heart troubles, vision loss, accidents, diabetes, mental confusion, loss of consciousness and psychiatric side effects.

The drug mimics the effects of nicotine and is said to help people stop smoking fairly effectively.

The FDA’s Center for Drug Evaluation and Research says the agency is looking at the hundreds of adverse reactions to Chantix. “We are looking at them, but it takes a while,” says Janet Woodcock of the FDA told Reuters

The FDA’s position has been that Chantix should remain on the market to help smokers quit. The agency issued a public safety advisory this year for patients and health care providers to be on alert for changes in the mood and behavior of those taking Chantix.

A study from the Institute for Safe Medication Practices finds that in the last quarter of 2007, there were 988 serious injuries reported to the FDA, more than for any other drug reports during the same period.  

It is reported that 35 drugs had more than 100 serious adverse event reports (SAE). Chantix was first at 988 reports, while interferon beta had 640. Etanercept (555), infliximab (554), and fentanyl (404), oxycodone ( 372) followed.     

Woodcock tells Reuters, "We are not able to put the amount of resources against this we would need to do it in a very prompt matter.”

Following that report, the Federal Motor Carrier Safety Administration warned truck drivers not to use Chantix and medical examiners to disqualify anyone currently on the medication from obtaining a commercial motor vehicle license.

The Federal Aviation Administration banned the use of Chantix for pilots and air traffic controllers last week.  And
the military reportedly bans the use of Chantix for missile and flight crews.

One of the side effects is an inability to operate machinery and the tendency to have accidents.  Among the reports to the FDA were over 170 accidental injuries and about two dozen traffic accidents which the Institute linked to Chantix use. 

Daniel Williams had no health problems when he began taking Chantix to quit smoking. His girlfriend reports that a couple of nights after starting the drug, he was driving his pickup truck on a Louisiana country road.

She says she saw his eyes roll back into his head and he swerved off the road landing in a bayou.  Both got out alive and his doctor connected the incident to his use of Chantix.  

Earlier this year, the label on Chantix was updated to warn of suicidal thinking and depression.  Vivid dreams, also known as “Chantix dreams,” are also a frequently reported side effect.

Kathy MacInnis says Chantix put her in a calm place and she reports no health problems.  “You kind of feel high,” she tells the Los Angeles Times.

Pfizer flew her to New York to tape some commercials.

Prescriptions for Chantix are reported to be declining and shares of Pfizer closed at $19.33, down $.20 from the previous day.

Pfizer says that 5.5 million Americans have taken Chantix so the proportion of problems, reported to be more than 3,000, is relatively small in comparison.  

And withdrawal from nicotine might be a complicating factor.   #


4 Comments

Anonymous User
Posted by Gerard Abate
Wednesday, May 28, 2008 10:21 AM EST

One has to remember that only a fraction of adverse events are reported. There are hallucinations( out of body experiences etc) and vivid dreams that are quite severe when one sees the adverse event reports. There is no way to determine who is at risk for these and therefore physicians need to caution against even driving the first two days of using CHANTIX. We also need to remember that we should look at the number of labeled adverse events reported since CHANTIX labeling lists many of these. The drug may help with smoking cessation but the potential for a significant number of SAE's( serious adverse events) is high.

Anonymous User
Posted by Chrsitne
Wednesday, May 28, 2008 4:34 PM EST

I have been taking Chantix for almost a month now and haven't had any adverse effects such as inability to drive, odd dreams, hallucinations, depression, etc. I haven't smoked in 18 days and have no cravings for nicotine. I admit the side effects lited in the prescription were a little scary but I wanted to quit more than I was afraid of them happening to me. I'm also not on any other medications so maybe that is a factor. I hope all who take it remain safe and smoke free as it has really helped me to quit!

Anonymous User
Posted by Liz
Wednesday, May 28, 2008 8:25 PM EST

I've been taking Chantix for the last week, after experiencing extreme mood swings and manic behavior I decided to discontinue. I do struggle with depression and anxiety and am on meds for that. As much as I would have liked a quick fix to quit, the side effects were to much for my mental health.

Anonymous User
Posted by Betty
Thursday, May 29, 2008 1:24 AM EST

When did the military ban use of their flight and missile crews from using chantix? I know the military was suggesting it to soldiers and somehow it doesn't seem right to have miltary personnel with guns using chantix either. What about other jobs that have guns? The risks of taking chantix are far greater then a few days of suffering nicotine withdrawals or using another replacement then a drug that as this article quotes one mother saying, "You kind of feel high." The risks are too high!

Comments for this article are closed.

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