February 01, 2003


 Veterinary use of thalidomide forbidden by FDA

Posted Jan. 15, 2003

To protect the public from the serious health risks posed by thalidomide, the Food and Drug Administration restricts the distribution of thalidomide to registered physicians for prescription. Veterinarians, however, are prohibited from prescribing the drug, according to the FDA.

The FDA Center for Veterinary Medicine published a reminder to veterinarians about the status of thalidomide in the November/December issue of FDA Veterinarian. The issue can be viewed online at http://www.fda.gov.

Thalidomide is approved to treat skin lesions in humans associated with erythema nodosum leprosum. Because of the drug's potential to cause severe birth defects in human fetuses, however, the FDA has invoked its authority to tightly control the marketing of thalidomide through the System for Thalidomide Education and Prescribing Safety program. The program is designed to ensure that no human fetus is exposed to the drug. It restricts availability of the drug and requires careful assessment of all adverse reactions and fetal exposure.

Extralabel use of approved human drugs in nonfood-producing animals by veterinarians is generally permitted when there is no threat to public health; however, thalidomide poses a threat to public health, so veterinary use is not allowed. The FDA will not exercise enforcement discretion to allow veterinarians to use thalidomide for investigational purposes, nor will the agency allow importation of thalidomide for personal use, and all imports of thalidomide whether intended for human or animal use will be detained.