October 23, 2008

Chantix Is Tops At Causing Problems

Chantix, Pfizer's stop smoking drug, topped the list of drugs causing problems that led to adverse events reports being filed with the FDA in the first quarter of 2008. The stop smoking drug, which sure unglues people like a bad old SSRI, racked up a total of 1,001 adverse events reports and reports of another 50 deaths linked to the use of the drug, according to the Institute for Safe Medication Practices. That's simply astonishing for a drug that's barely two years old--and which I was one of the first in the media to identify as a problem drug last year.

You can read ISMP's report here.

Other problem drugs included heparin and OxyContin.

Posted by Philip Dawdy at October 23, 2008 12:03 AM
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Comments

The Chantix series is great reporting here, the link to your series is worth reading for a review of just how cutting edge this blog is!

Posted by: Stephany at October 23, 2008 06:40 AM

There are too many conflicts with many of those cases to blame them all on Chantix.

Posted by: Dale Hanks at October 23, 2008 10:43 AM

Dale,

What exactly are the "too many of those cases"? When side effects from medications are reported to the FDA no personal information is provided. The drug companies have no way of knowing if someone who suffered the side effects of this drug were in fact mental ill. The drug company for Chantix is attempting to do what it did successfully with antidepressants, blame the patients.

Without personal information the drug company are spinning the drug effects. Blame the patient for an underlieing psychiartic disorder and keep selling the killer drug. They also believe they can get away with this because society hates smokers just like they hate people with mental illness.

It will be very interesting to see the raw data on this drug once the lawsuits get going. I won't in the least bit be surprized to find some pretty horrible side effects occurred in the trials that were hid and covered up. There is a reason pfizer excluded anyone with a mental illness from being in their studies. A population that the drug companies hoped to pursue with the drug. I read a press release that stated the mental ill was the population they intended to target. So why were they excluded?

I also think we will find that the doctors pushing this medication have huge conflicts of interest. The psychiartic side effects are not only occuring in patients that stopped the nicotine. Even people who did not stop smoking have suffered the consequences of this drug. Stop blaming the patients, at least until all the data is in.

Posted by: carol at October 23, 2008 12:29 PM

It's on the market on Brazil. sorry, I have to say it from time to time.
Nothing is said about any of these hideous side effects of any drug in Brazil.
Even Vioxx went out off the market and nothing was said about the reason.
Celebrex is on the market! I was prescribed it this month!
I feel terrible. There's nothing I can do.
Absolutely nothing! Every time I go to a pharmacy I see some of this drugs being bought.


Posted by: Ana at October 23, 2008 01:14 PM

What I consider to be the moronic statement of at least the month from a Pharaceutical company:

"Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects."
(from an article at http://news.aol.com/health/article/reports-of-serious-drug-reactions-hit/221460?icid=200100397x1211367697x1200749465 )

Also quoted from the above article (and what seems to me to be one of the FDA's core problems)

"The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems."

I focus mainly on the words "voluntary reports" in that sentence.

I didn't realize, until earlier this year, that doctors were not required to report adverse events to the FDA.

While I was on Lamictal I was experiencing severe spike headaches (once caused temporary blackout while I was driving) and nose bleeds. After going through previous medical records I discovered I had been on Lamictal years earlier and had experienced the same side effects. (Didn't remember it because of memory voids caused by ECT.) The Pdoc I was seeing that had prescribed it the second time stated he'd never seen that side effect before. But I have since learned he did not submit an adverse event report.

My point being, I guess, that if they are not REQUIRED to make reports, then how do they really know whether a side effect is common or rare? If doctors are relying predominently on the side effects cited during trials and not following up through reporting all adverse effects, then no one is getting the real picture of how a drug is doing. And we're all familiar how the psychiatric community feels about anecdotal "evidence". Wouldn't making an official report to the FDA kind of make it less anecdotal?

Posted by: SallyT at October 24, 2008 05:13 AM
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