Monday, September 8, 1997
BETHESDA, Md. - An FDA advisory committee voted Friday that
the benefits of making thalidomide available on a restricted basis to some leprosy
patients outweigh the known risks, including the possibility that pregnant women
could take the drug and give birth to severely disabled children.
The recommendation was based on Celgene Corp.'s application
to market its formulation of thalidomide for treatment of skin lesions and fever
associated erythema nodusum leprosum (ENL), a severe and debilitating condition
that afflicts leprosy victims.