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thalidomide for leprosy treatment posted 9-15-97 The dangers and benefits of thalidomide—banned 35 years ago after it caused severe birth defects—are being reconsidered following a Food and Drug Administration advisory committee recommendation that the drug be approved for treating leprosy. The committee made its recommendation Sept. 5, at the same time urging the FDA and the drug’s manufacturer to closely monitor the drug’s distribution and use. Thalidomide—never approved for use in the United States—was used by pregnant women worldwide in the 1950s and 1960s to treat morning sickness. In 1962, the drug was banned after research established a conclusive link to birth defects in nearly 10,000 children born to women who had taken the drug. Now, thalidomide is being cautiously backed by researchers who have determined that the drug relieves symptoms of erythema nodosum leprosum, a complication of leprosy causing skin lesions and high fever. Thalidomide is also said to be effective in treating symptoms associated with AIDS and is reported to be in demand on the black market among AIDS patients in San Francisco. Clinical trials are under way to determine the drug’s effectiveness against various cancers and other diseases. Panel members were quick to acknowledge the devastating birth defects caused by thalidomide, including missing limbs and eyes. But panel members said it’s better to legalize the drug under strict controls rather than have desperate patients use it illegally and without proper supervision, as some do today. Celgene, the drug’s manufacturer, has presented a distribution plan emphasizing patient education, informed consent, and pregnancy testing. While the FDA is not obliged to follow the independent panel’s recommendation, it tends to act on the researchers’ advice. Anticipating increased use of thalidomide, some healthcare professionals have expressed reservations regarding its industry-wide legitimization. "Certainly people with AIDS and leprosy should have access to this drug when it’s indicated," said John Harris, director of the California Birth Defects Monitoring Program. "But I have serious concerns that it not be used for purposes other than those for which it’s approved. Strict restrictions and procedures must be put in place. One baby with birth defects is one too many." Related Site |
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