May 19, 2008

FDA Issues Public Health Warning On Chantix, The Stop Smoking Drug

On Friday, the FDA issued a formal public health advisory on Chantix, the stop smoking drug made by Pfizer that's been leading to all manner of suicides, suicidality, erratic behavior and reported cases of drug-induced depression. It's like the strangest SSRI ever engineered by Big Pharma. It's interesting that a drug given to address what public health officials consider a public health problem--that would be smoking--is turning out to cause public health problems of its own. But since they are public health authorities and are, therefore, humorless, it's not likely that they'll understand the irony.

Anyway, the FDA advisory specifies:

"Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

"Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

"Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

"Patients taking Chantix may experience vivid, unusual, or strange dreams.

"Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

Much of this echoes what I've been writing about this drug on this website since last September right down to the fact that the problems seem to appear mostly in people with underlying DSM conditions, past or present. I'm not bragging, but I am pointing out that I was right. And, I thank the many, many people who experienced problems on Chantix for helping alert me and others to the problems with this drug.

I'd be remiss if I didn't point out that this warning is going to cost Pfizer sales of Chantix. That's because doctors have been trying for years to get their patients diagnosed with schizophrenia, bipolar disorder and depression to stop smoking and these groups of people tend to smoke at rates much higher than the general population. I'd say that any doctor with brains who knows his or her patient has a DSM diagnosis is not going to even bring up the possibility of his or her patient taking this drug. Looks like we are going to find out how many smart doctors there are out there.

Posted by Philip Dawdy at May 19, 2008 12:01 AM
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Comments

I predict there will still be doctors who prescribe this to people at high risk for adverse effects....they prescribe all the psychotropics without batting an eye and ignore adverse effects all the time...

also there is horrible scorn directed at "the severe and persistently mentally ill" for their smoking habits. Some docs will, I'm sure still think the risk is worth it.

I spent a significant amount of my time as a social worker trying to undo guilt trips placed on my clients about their smoking...it's a really sad state of affairs. Doctors playing god. Determining what is right or wrong for a patient.

Posted by: Gianna at May 19, 2008 05:46 AM

Isn't it interesting how the FDA seems to always issue these type of warnings on Friday afternoons when no one is paying attention?

Posted by: Jane at May 19, 2008 08:33 AM

The Friday afternoon warning from the FDA will do little good. Most docs prefer a patient to be nonsmoking & dead rather than alive and smoking.

The fraudulent "second-hand smoke" studies led to all this. Also, there were big bucks to be made if you were a member of ASH.

Posted by: Rosie C. at May 19, 2008 12:11 PM
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