| Pfizer Inc.'s (PFE) new smoking-cessation drug Chantix is going through a hard time since it blamed for musician's death. In this context, the U.S. Food and Drug Administration stated it is examining reports of some users of drug Chantix who have engaged in erratic behavior, have had suicidal thoughts or experienced other side effects.
In particular, the FDA said it's aware of a "highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking." This appears to be the recent case of a Texas musician who began taking the drug, then reportedly engaged in aggressive behavior that preceded his shooting death.
The FDA further added that although other factors, including alcohol consumption, appear to have played a part in the musician's case, the agency asked Pfizer for additional cases that might be similar. The FDA is currently evaluating the material Pfizer submitted in response to its request.
On the other hand, Pfizer— the largest drug maker in the world by sales, has said clinical studies don't suggest that Chantix use leads to rage. Pfizer further added that it has updated Chantix's product label to include reports of depressed mood, agitation, changes in behavior, suicidal ideation, and suicide in patients attempting to quit smoking while taking Chantix.
Both the FDA and Pfizer indicated it was too soon to conclude that Chantix caused the side effects.
Chantix— Approved by the U.S. Food and Drug Administration in May 2006— is a nicotine-free, oral tablet taken up to twice daily for 12 weeks to help adults stop smoking, a leading cause of death and disease. Its active ingredient is varenicline, which is designed to work by cutting the pleasure of smoking and reducing withdrawal symptoms. According to Pfizer, Chantix costs about $3.36 per day. And More than 4 million people in the U.S. have taken the drug.
James Kelly— Goldman Sachs analyst – said the FDA's alert could heighten awareness of psychiatric symptoms and Chantix. He noted that Chantix was associated with higher rates of abnormal dreams and insomnia than fake pills in studies. He also included "It will be key to watch physician behavior in the wake of this public disclosure, as well as the FDA's future communications, based on additional data and analysis provided by Pfizer." In the wake of FDA alert, Pfizer shares may come under some pressure.
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