FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 


T97-43                      Ivy Fleschier Kupec:  301-827-6242
Sept. 5, 1997               
                            Consumer Inquiries:   800-532-4440

       ADVISORY COMMITTEE RECOMMENDS THALIDOMIDE APPROVAL

     FDA's Dermatologic and Dental Drugs Advisory Committee
recommended today that FDA approve thalidomide for erythema
nodosum leprosum (ENL), a serious inflammatory condition in
leprosy patients.  However, the committee also strongly urged FDA
officials and the manufacturer to limit distribution and take
measures that would assist in preventing birth defects and other
side effects of thalidomide exposure.
     Today's advisory committee made its recommendation on the
basis of an analysis of the totality of available data, including 
historical data provided from the Public Health Service
experience that demonstrated thalidomide's effect in treating ENL
for more than 30 years, as well as the published literature. 
     Thalidomide manufacturer, Celgene also presented a
distribution plan which would include patient education,
physician education, informed consent documentation, required
pregnancy testing and other usage surveillance, including a
mandatory registry.  
     Other meeting participants, including the Canadian
Thalidomide Victims Association, contributed to a discussion of
potential birth defects, addressing adverse event tracking
mechanisms and the need to limit thalidomide distribution.
     Thalidomide is a drug originally marketed as a sedative      
outside the United States from the 1950s to early 1960s, until it 
was linked with severe birth defects.  In addition to causing
serious fetal deformities, thalidomide has been associated with
other adverse reactions, including peripheral neuropathy, a
disorder, that, in some patients, has resulted in permanent nerve
damage.  The product has never been approved for use in the
United States.
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