Zyban And Chantix Worse Than Smoking?

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Smoking is often deadly. Apparently two popular smoking-cessation drugs could be too. July 1, the Food and Drug Administration required Pfizer and Glaxo to place black box warnings on their stop-smoking products Chantix and Zyban.

The FDA’s most serious mandate was issued after receiving at least 98 reports of suicides and 188 reports of attempted suicides by people taking Chantix. Zyban also proved extremely unhealthy with 14 suicides and 17 reports of attempted suicides among users.

It is unclear why these products are causing tumultuous mental problems. Nicotine withdrawal is one theory but some of the events involved patients who were still smoking. Many reported changes in behavior, depression, hostility, and suicidal thoughts both at the beginning or end of their drug therapy. Others had adverse effects even after the medication was stopped.

Federal drug czars have known of Chantix and Zyban’s potentially deadly consequences since 2007.

European officials notified the agency of a media blitzed Chantix related death that occurred in September of that year. Carter Albrecht, a keyboard player for the group Edie Brickell and the New Bohemians, was killed by a neighbor who complained that the musician was pounding on his door, in a rage. Albrecht’s girlfriend claimed Chantix made him hostile.

The FDA previously had issued mental health warnings involving Chantix, and required similar ones for Zyban when it was marketed as Wellbutrin, an anti-depressant. Recently, the agency’s interest has increased concerning psychotic side effects of many medications including anti-depressants, anti-seizure drugs, and even various antibiotics.

In addition to the boxed warning, the FDA wants more information placed in the drug’s warning section area and updated mental health information in the medication guide for patients.

Also, manufacturers must now conduct a clinical trial to determine risks among those with known psychiatric disorders and too, mention the risk of suicide in their advertising.

One must always read the fine print.