FDA links anti-smoking drug to more than 500 suicides

smoking-gun

In the past five years, the Food and Drug Administration has received reports implicating the smoking cessation drug Chantix in 544 suicides and 1,869 attempted suicides, according to documents obtained by Al Jazeera America.

Since its introduction to the U.S. market in 2006, Chantix has been linked to an array of adverse psychiatric events, including suicidal behavior, depression, psychosis, and aggression. In 2008, senior researcher Thomas J. Moore of the Institute for Safe Medical Practice concluded that the drug was associated with more adverse effects than any other medication on the market. A concomitant health advisory released in May 2008 eventually prompted the Federal Aviation Administration (FAA) and the U.S. Department of Defense (DoD) to ban the drug among pilots and air traffic controllers…

That said, FDA has so far been reluctant to indicate a distinct causal relationship between adverse psychiatric events and Chantix, which is distributed in the U.S. by Pfizer Inc. In a safety review released last year, the agency noted that while reports of alarming side-effects have been filed regularly, it is exceedingly difficult to determine whether these actually resulted from Chantix use…

Study limitations notwithstanding, the FDA concluded that the benefit-risk profile of Chantix was unchanged, and recommended that the drug remain on the market under its current “black-box warning” – the most serious health warning the agency issues. Some would argue that the health warning, which lists as side-effects most adverse events reported to the agency, is an adequate precautionary measure that informs patients and physicians about the drug’s psychiatric influence…

“The use of a black box warning is to help physicians identify early symptoms that so that you can prevent the adverse event from occurring,” Michael Siegel, a professor at Boston University’ School of Public Health, told reporters. “In the case of Chantix, the black box warning is basically telling physicians, ‘Be careful because your patients might die taking this.’ What use is it to monitor patients for suicide? Once they commit suicide, it’s over.”

How many doctors, how many smoking cessation specialists – how many members of Congress – does Pfizer own? Is it a sufficient number to keep medication with this kind of track record on the streets?

The FDA admits studies used to justify approval may be flawed. Then, pull the stuff off the market until legitimate studies reexamine the safety of this product.

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