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FDA Issues Warning on Smoker's Drug

Posted by Jane Akre
Monday, February 04, 2008 1:38 PM EST
Category: On The Road, Major Medical, Protecting Your Family, In The Workplace
Tags: Chantix, FDA and Prescription Drugs, Toxic Substances, Wrongful Death

FDA issues an advisory on Chantix. Link to suicidal thoughts, anxiety.  

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Andrea Ross has been trying to quit smoking since New Year's day.

She turned to Chantix, the smoking-cessation tablets. Ross says they really help but she’s had such vivid dreams that she now takes a quarter of a sleeping pill so she  has undisturbed sleep.  “Unbelievably vivid dreams otherwise,” she tells IB News.

The Food and Drug Administration believes it and has issued a public health advisory about Pfizer’s Chantix. The drug likely is tied to serious psychiatric symptoms including thoughts of suicide, depression and behavior changes.

The FDA has received nearly 500 reports of suicidal behavior and 39 reports of suicides, mostly in the U.S. among users of Chantix. Several suicide cases were in patients with no history of psychiatric problems.

Now, the FDA said, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."

"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, told reporters on a conference call Friday.

Pfizer, the world’ largest drug maker maintains there is no evidence of a casual link and some symptoms may be the result of nicotine withdrawl.

Still, Pfizer upgraded the warning label last month to more promenintly display the post-marketing reports of adverse effects.  A stronger label was first added last November after an FDA assessment of the side effects consumers have been reporting. 

The FDA said it was working with Pfizer to develop a guide that highlights the warning for patients and doctors.  Patients are urged to tell their doctor about any history of psychiatric illness before starting Chantix as it could cause a recurrence. Patients are encouraged to report any mood changes to their doctor. They can also appear after you stop taking the drug. 

Besides vivid dreams you are also warned that you may experience an inability to drive or operate heavy machinery while on Chantix.

The drug is said to be effective. Sales during the fourth quarter were $280 million up from $68 million during the same time period a year prior.

The tabled Chantix is taken up to twice a day for 12 weeks to help adults stop smoking. Unlike a patch that replaces nicotine, Chantix works on the brain centers affected by nicotine and recreates some of the pleasing effects of nicotine

About four million people in the U.S. have used the drug since its approval in May 2006.   The FDA continues monitoring the drug calling it an “evolving issue. #


1 Comment

Anonymous User
Posted by Robert Campbell
Friday, February 08, 2008 12:22 PM EST

Chantix was very helpful for me in quitting smoking after 40 years and has also helped three other people I know, with no side effects that I have heard of. These people also had been smoking about as long as I.

When I first inquired of my health carrier why it was not a tier one drug, however, they told me that it was a tier two drug, the first one which they would pay for to stop smoking being Wellbutrin. As I did not believe and was not advised that my smoking was related to depression at this stage, I paid for my own prescription for Chantix and did not take any Wellbutrin or any antidepressant as a prelude.

Not being a health care professional at all but a patient, I do not see why an antidepressent such as Wellbutrin would be prescribed for smoking, But if someone were taken off the anti-depressant and then put on Chantix who knows what the cause would be? Maybe that should be addressed in more articles on this topic.

As I head into my first year without smoking as a result of Chantix I am very happy that I did not start with any other medication for this purpose than Chantix and am grateful to Pfizer for producing this product.

Comments for this article are closed.

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