THALIDOMIDE

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• 作者：Carrie L. Radomsky ; PharmD ; MD^* ; Norman Levine ; MD^*
• 刊名：Dermatologic Clinics
• 出版年：2001
• 出版时间：1 January 2001
• 年：2001
• 卷：19
• 期：1
• 页码：87-103
• 全文大小：1600 K

文摘

Thalidomide first was produced in Germany in the early 1950s and was marketed under the brand name Contergan in 1957. The drug was promoted as a safe sedative and was found to be useful as an antiemetic during pregnancy, resulting in its widespread use throughout Europe. In late 1960, reports of neuropathy associated with long-term use of thalidomide first appeared. Shortly afterward, the use of thalidomide was associated with the appearance of previously rare birth defects¡ªdeformities of the arms and legs?which afflicted approximately 12,000 newborns. This discovery resulted in the withdrawal of thalidomide from world markets in 1961. Thalidomide had not been sold in the United States because of careful scrutiny by the Food and Drug Administration (FDA), which insisted on more data regarding its neuropathic side effects as well as its safety during pregnancy.

For years, thalidomide was available only for strictly defined research purposes. In 1997, an FDA advisory committee recommended the approval of thalidomide for the treatment of erythema nodosum leprosum (ENL), which led to its July 1998 final approval for use in this condition in the United States. The FDA approval of thalidomide for ENL allows its use in many currently unapproved circumstances. This article reviews the pharmacology, adverse effects, and regulatory concerns and provides general therapeutic guidelines for the use of thalidomide in various dermatologic conditions.