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7/21/1998

FDA Approval of Thalidomide

Cheryl A. Thompson

On Thursday, July 16, 1998, ASHP staff participated in a conference call with Food and Drug Administration officials and health professional organizations to discuss the FDA approval of thalidomide for the treatment of skin lesions caused by erythema nodosum leprosum (ENL) (a complication of Hansen's Disease, commonly known as leprosy). Because of thalidomide's known potential for causing birth defects, FDA invoked unprecedented regulatory authority to tightly control the marketing of thalidomide in the United States. A System for Thalidomide Education and Prescribing Safety (S.T.E.P.S) oversight program has been initiated that includes limiting authorized prescribers and pharmacies, extensive patient education about the risks associated with thalidomide and a 100% patient registry. 

We make this information available to assist pharmacists in their important role in the program, and in answering questions consumers and prescribers are likely to ask about this issue. In addition to posting this on our Web site, we distributed a fax communication to aid State Societies and the Public Relations Network to aid in pharmacist's responses. 

Thalidomide Information—Includes the information listed below and more. 

  • FDA Talk Paper
  • Information for Consumers
  • Frequently Asked Questions
  • Patient Information
  • Approved Labeling
  • Thalidomide: Potential Benefits and Risk. An Open Public Scientific Workshop Sponsored by the National Institutes of Health and the Food and Drug Administration, September 9-10, 1997, Bethesda, MD.
  • Posted July 21, 1998. Source FDA.