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FDA wants black box warnings on Chantix and Zyban
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Substance abuse and addiction are mental health issues, and are often co-morbid to biologically based brain disorders such as bipolar disease, schizophrenia and depression. Smoking, alcohol and illegal drug use (i.e. cocaine, heroine, marijuana) are among the addictions and substance abuse disorders.
Smoking is one of the most common addictions that seems to accompany mental illness. Often it is not recommended to try to stop smoking until and unless the mental illness is stabilized as the added stress of quitting smoking can exacerbate the symptoms of the mental illness.
Recently, the FDA (U.S. Food and Drug administration) requested black box warning labels be added to two drugs used to assist in smoking-cessation. Chantix from Pzizer and Zyban from GlaxoSmithKline have been found to cause an increased risk for suicide. They have also been shown to have other severe neuropsychiatric side effects such as mood swings and aggressive behavior issues.
Pfizer has had warning labels on Chantix since 2007, but is adding the stronger black box warning label to its product.
Janet Woodcock, director of the FDA’s drug division stated, “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking.” The FDA has issued this request for black box warnings after careful study of side effects reported to the FDA, clinical trial information and scientific literature.
Those persons who have biologically based mental illness may already be at increased risk for the suicidal tendencies, mood swings and aggressive behavior issues. They should use these drugs with extreme caution and should discuss the increased risks with their health care practitioners and alert their support system of family and friends. Alternative solutions may be a safer answer.
