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FDA Releases Suicide Warning For Anti-Smoking Drugs


Posted on Jul 15, 2009

For years we have known that smoking is bad for our health - but now the Food & Drug Administration (FDA) is warning consumers that anti-smoking prescription drugs may be even more harmful. On July 1, the FDA issued a nation-wide warning that two of the most popular anti-smoking drugs on the market, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, have been linked to severe depression and suicide in a number of patients.

For Zyban, there have been 14 reported suicides and 17 reported attempted suicides across the country.

While the FDA's statement made clear that those taking Chantix and Zyban should be extremely wary of mental illness, clinical depression, and thoughts of suicide while taking the drugs, it did not recall the drugs or tell patients to discontinue use of the drugs. Dr. Curtis J. Rosebraugh, director of the FDA's drug evaluation office, explained that smoking is a serious health risk and that the agency did not want to prevent people from kicking their habit. Instead, those taking the drugs should simply be aware of the possible side effects.

Even so, Pfizer will add a black box warning to Chantix, while Glaxo plans to expand it's already-existing warning to include suicidal thoughts. In addition the FDA will require both companies to run clinical tests to further study the connection between the anti-smoking drugs and the risk of suicide.

Sales on both drugs are falling and expected to fall further, though representatives from both companies explained that the suicide link was known by doctors and patients before the FDA's warning and should not be a huge, drastic blow to sales.

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