Thalidomide, the FDA, and us -- what do you have? Underground compassionate use. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Thalidomide, the FDA, and us -- what do you have? Underground compassionate use. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Notes Undergr. 1995 Winter;(no 29):1-3, 8. Unique Identifier : AIDSLINE AIDS/95700301

Abstract: It comes as no surprise to those in the underground that thalidomide, a TNF-inhibitor, is still defined by its teratogenicity, or ability to cause birth defects. In the late 1950s, thousands of babies were born with horrific birth defects after a company started marketing the drug as safe for morning sickness. Forty years later, after three double blind placebo-controlled studies, numerous case studies, and hundreds of anecdotal reports from doctors treating oral and throat ulcers, the drug is still in clinical trials, and not yet available to treat AIDS-relatetd wasting. Pilot studies of the drug show significant weight gain for patients. In addition, the drug is inexpensive and offers a specific mechanism of inhibiting an inflammatory chemical called TNF-alpha, the substance which presumably aggravates weight loss in people with AIDS. The Underground Thalidomide Compassionate Use Program will begin providing thalidomide as soon as they can secure a safe pharmaceutical supply.

Keywords: Acquired Immunodeficiency Syndrome/COMPLICATIONS Cachexia/*DRUG THERAPY Clinical Trials Human Teratogens Thalidomide/ADVERSE EFFECTS/*THERAPEUTIC USE United States United States Food and Drug Administration NEWSLETTER ARTICLE
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