Ever since Pfizer Inc.’s smoking-cessation pill, Chantix, entered the U.S. market in 2006, it has been dogged by tragedies.  The U.S. Food and Drug Administration has received reports of thousands of serious psychiatric events, including suicides, attempted suicides and depression.

But two new federal studies have found that the prescription drug is no more likely to cause psychiatric problems leading to hospitalization than nicotine replacement therapies such as NicoDerm patches.

As Bloomberg reports, the the FDA sponsored the studies, one by the Department of Veterans Affairs and the other by the Department of Defense, which both tracked patients in 2006 and 2007.

The Veterans Affairs study covered 14,131 Chantix users and a similar number of people who relied on nicotine replacement therapy.  Of those studied, 16 patients from the Chantix group, and 21 from the nicotine replacement therapy group, were hospitalized for psychiatric reasons.

The Defense Department study tracked 11,978 Chantix users and a matching number of replacement therapy patients. In that research, 18 Chantix patients were hospitalized for psychiatric reasons, versus 16 replacement therapy patients. In neither study were the differences in the numbers of people hospitalized in the two groups considered statistically significant.

The FDA, however, stressed that the studies had important limits. The main one was that it took into account only problems leading to hospitalization.

MacKay Jimeson, a spokesman for Pfizer, said the company is reviewing the findings. The company is also conducting its own large-scale study of Chantix’s behavioral effects but results won’t be available until 2017.

FairWarning reported in December that Pfizer failed in  years of clinical trials to test the drug on mentally ill smokers — despite the fact that a disproportionate number of smokers suffer from psychiatric illness and are a key part of the target market for smoking cessation treatments.

The drug carries a black box warning, the FDA’s strongest safety alert. The agency said it still believes both that the warning is justified and that the drug’s benefits outweigh the risks.

According to the FDA, from the drug’s approval in 2006 through mid-2011, approximately 8.9 million U.S. patients have received prescriptions for Chantix. Sales for Chantix reached $755 million last year, a decline of 14 percent since sales peaked at $883 million in 2007, according to The Associated Press.


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