ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Friday, December 13, 1996 TAG: 9612130063
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: BETHESDA, MD.
SOURCE: Associated Press
A federal panel recommended approval of an antidepressant Thursday as the first non-nicotine drug to help people quit smoking.
Bupropion, currently sold under the name Wellbutrin for treating depression, is safe and effective for the new use, the Food and Drug Administration's Drug Abuse Advisory Committee voted unanimously.
The manufacturer, Glaxo Wellcome Inc., wants to market it under a different name for quitting smoking. But the panel split, 4-4, on that question. Some members were concerned that using two names could result in problems if people are inadvertently given prescriptions under both.
The FDA is not required to accept the recommendations of advisory committees but usually gives their views considerable weight when deciding whether to approve new drugs.
Dr. Andy Johnston, who organized research trials on the drug, said that only about 10 percent of the people who try to stop smoking each year succeed. But, he said, in clinical trials the success rate ranged from 38 percent to 48 percent for people using bupropion and climbed to 58 percent when bupropion was used along with nicotine-providing devices such as patches that help smokers gradually reduce their need.
Johnston said the exact way bupropion works isn't fully known, but it appears to reduce the desire for tobacco, sometimes even making cigarettes taste bad to smokers.
One possible side effect worried the committee: Seizures have occurred in some users of the drug for depression. No seizures occurred during the trials of smokers, the company said.
The danger of a seizure was estimated at about one person in 1,000, and the committee worried that if the drug were sold under two different names people could wind up taking both versions and get a dose that increases the risk.
Some 46 million Americans smoke, and the government says smoking kills 400,000 a year. Surveys indicate three-fourths of smokers want to quit but have failed or are afraid to try.
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