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FDA panel recommends approval of thalidomide
September 5, 1997
Web posted at: 10:18 p.m. EDT (0218 GMT)From Medical Correspondent Jeff Levine
WASHINGTON (CNN) -- A U.S. Food and Drug Administration advisory panel has recommended that the drug thalidomide -- banned three decades ago because it caused major birth defects -- be approved for treatment of leprosy.
The vote Friday by the panel came despite the fact that FDA scientists recommended against approving the drug. However, some on the advisory panel voted to give the go-ahead because the drug is already available illegally.
"We're much more afraid of thalidomide being available as it is today," says panel member Randolph Warren, himself a victim of the drug.
CNN's Jeff Levine reports
2 min. 8 sec. VXtreme video
In the 1950s and 1960s, about 10,000 children worldwide suffered birth defects after their mothers took thalidomide to treat morning sickness. The drug -- never approved for use in the United States -- was banned in 1962.
But thalidomide has been making a comeback. It has proven effective for thousands of leprosy patients afflicted with painful sores, and it also has been used to treat nausea and weight loss symptoms associated with AIDS.
If the FDA accepts the panel's recommendation, use of the drug will be subject to what one FDA official called the strictest controls in the agency's history.
Thalidomide's manufacturer, Celgene, has agreed to require signed, informed consent forms from patients, as well as pregnancy testing and birth control. It may also put a picture of a deformed child on the package.
"There is no perfect system, but what we have as our objective and our intent is to insure there are no more (thalidomide babies) that are born," said Celgene's Sol Barer.
The FDA's final decision isn't expected for several months.
Related story:
- Thalidomide's comeback sparks emotional debate - September 4, 1997
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