BioCentury
ARTICLE | Regulation

Thalidomide moves back into the public eye

November 11, 1996 8:00 AM UTC

ROCKVILLE, Md. - FDA approval of thalidomide and its subsequent widespread use could result in some cases of birth defects, but this possibility should not deter FDA from approving it as a treatment for erythema nodosum leprosum (ENL), a painful condition associated with Hanson's disease (leprosy), the chairman of an FDA advisory panel said on Friday.

At the end of two days of public deliberations about potential safety issues associated with the use of thalidomide for ENL, Dermatologic and Ophthalmic Drugs Advisory Committee chairman Joseph McGuire Jr. said widespread use could lead to some birth defects similar to those that shocked the world in the 1960s. But McGuire, professor of dermatology and pediatrics at Stanford University School of Medicine, said thalidomide's benefits could outweigh the risks of teratogeny (literally, "monster-formation")...