December 14, 2007

Chantix/Champix To Get Suicide Warnings In Europe

The other day Pfizer, maker of the stop smoking drug Chantix (Champix elsewhere), was ordered by Australian authorities to put warnings related to risks of suicide, suicidality and depression linked to the drug's use on its packaging before the drug goes on sale in Oz next month. Now, the European Medicines Agency is ordering Pfizer to put the same warnings on the drug in Europe. So far, the FDA has not ordered any label changes in the US. You have to assume they are in the offing for the drug which has been associated with hundreds of adverse events reports about suicide, suicidality, depression, agitation, and erratic behavior in the US.

To me, the big question is why does the FDA always seem to move slower than other drug regulatory agencies. And, for that matter, why does Pfizer still refuse to answer questions about reported problems with the drug.

Posted by Philip Dawdy at December 14, 2007 09:24 AM
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The FDA move slower than Europe's and Australia's agencies because, obviously, they are controlled by money maker pharma and the docs.

Most docs think it is better that someone die from Chantix than it is to live and continue smoking. So pharma has it on easy street in this particular instance. No other segment of our society has ever been treated as lowly as the tobacco somkers. Even the alcoholics were able to garnish some compassion - so too the victims of AIDS and illegal drug use. But never the smoker - they are pariahs. Some docs won't even operate now for a broken leg if that person is a smoker. A veteran of World War II, age 84, died two years ago in Michigan when he left his nursing quarters for a smoke and the door locked behind him late at night. He froze to death. The only question, I imagine, that any docs had was "Why was this man not on Chantix?"

Posted by: Rosie at December 14, 2007 02:50 PM

Whoops! In the previous post here, I used the word "garnish" in relation to "compassion" when I meant to say "garner".

Well, Chantix will be around for awhile in the U.S. because 48 million people are "in hiding". These are the smokers and they are desperate so they will try anything to rid themselves of the habit so they can rejoin society. The risk of suicide will seem mild to them compared to what they have to endure now.

Posted by: Rosie at December 14, 2007 04:58 PM

No other segment of our society has ever been treated as lowly as the tobacco somkers.

I beg to differ---I think those of us labeled mentally ill are treated just as lowly and often much much worse. I've been both a smoker and labeled psychiatrically---therefore I've also been treated as both.

Smokers still don't get forced treatment and restraints, right?

Posted by: Gianna at December 14, 2007 10:47 PM

I have to agree with Gianna. There is some study floating around that states that mental illness carries the highest degree of stigma of any disability and watching the behavior of other toward my children I have to agree. Let's not even get into how poorly their needs are/are not met, and the lack of compassion that often goes along with the help.

I think of smokers as huddling outside their workplace to smoke on a cold day, or being banned from a bar. This just doesn't compare to the shunning, poor help, medical conditions like diabetes, homicide/suicide from drugs, and other death caused by pharmaceutical drugs that are suffered by a person with mental illness.

What ever happened to cold turkey? Worked for me.

Posted by: Sorrowful at December 15, 2007 04:49 AM

I forgot to mention my observation in 2003 about the FDA always being last to place warnings on a drug. In the Spring of 2002, Japan and the UK required Lilly to place warnings for diabetes, hyperglycemia and death on Zyprexa. It wasn't until late 2003 that the FDA, after being slammed by three large, front page articles about the drug, required all atypical makers to place a similar warning (they refused to single out Lilly). This is an ongoing pattern, even though they "say" that they work with other countries on drug safety.

Posted by: Sorrowful at December 15, 2007 04:53 AM
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