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October 8, 1997

Thalidomide Back—Under Strict Control

JAMA. 1997;278(14):1135-1137. doi:10.1001/jama.1997.03550140025013

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THALIDOMIDE, the notoriously teratogenic agent of the 1960s, is about to become a prescribed drug. Just 17 days after an advisory committee of the Food and Drug Administration (FDA) recommended that the acting commissioner give marketing approval to thalidomide for treatment of erythema nodosum leprosum (ENL), a complication of lepromatous leprosy, FDA informed the maker that the drug would be approved.

This use has been studied since 1965. The condition is estimated to affect only a few thousand people in the United States, but when approval is granted, the door will be open for physicians to prescribe the drug as they wish. A number of uses of thalidomide are under active investigation and some have shown considerable promise. However, even apart from its teratogenic potential, the drug is not without such occasional serious adverse effects—especially with long-term use-—as irreversible peripheral neuropathy.

Thalidomide is an inhibitor of the cytokine tumor