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FDA advisers back anti-depressant as aid to stop smoking
December 13, 1996
Web posted at: 5:30 p.m. ESTFrom Medical Correspondent Jeff Levine
In this story:
BETHESDA, Maryland (CNN) -- A drug currently used to treat depression could soon become the first non-nicotine medication to help Americans quit smoking.
An advisory committee for the Food and Drug Administration said Thursday the anti-depressant Wellbutrin is safe and effective when used as a smoking-cessation tool.
Former Health and Human Services Secretary Louis W. Sullivan called the drug another means to help end "the tremendous carnage" that results from tobacco use.
The committee also recommended approval of the Nicotrol Inhaler, a device designed to help smokers kick their habit by allowing people to mimic the hand-to-mouth motion of smoking a cigarette.
Words of caution
According to the manufacturer of Wellbutrin, patients were twice as likely to quit smoking when using Wellbutrin over a placebo and four times as likely to quit when using the drug coupled with a nicotine patch.
But while the panel voted unanimously to approve the use of the new drug, members cautioned that the pill can cause harmful side effects, including seizures in some patients. The danger of a seizure was estimated at about one person in 1,000. The panel also urged that the drug be used in connection with a smoking-cessation program.
The FDA is not bound by the recommendation but usually accepts them. If the FDA concurs, the drug would be the first non-nicotine treatment for getting smokers to quit.
Wellbutrin is manufactured by Glaxo-Wellcome and is currently approved for treating depression. It has been tested as a smoking cessation tool in about 2,000 people.
If the drug is approved, it will most likely be sold as Bupropion SR tablets. But committee members said they are worried that if the drug is sold under two different names people could wind up taking both versions, increasing their risk for complications.
Nicotrol Inhaler
The Nicotrol Inhaler allows smokers to mimic smoking motions, and it contains a cartridge with 10 milligrams of nicotine that lasts for 20 minutes if used continuously.
The Inhaler differs from cigarettes since it has no tar, carbon monoxide or carcinogens.
The technology behind the Nicotrol Inhaler was developed by Advanced Therapeutic Products and acquired by Pharmacia & Upjohn Inc. in 1987. The Inhaler will be marketed in the United States by McNeil Consumer Products, a Johnson & Johnson Company.
The company promised to work with the FDA to address concerns about labeling and packaging. The advisory committee was concerned that children not have access to the device.
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