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FDA Issues Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDS

Date: December 22, 2000
Source: Food and Drug Administration (FDA)

The Food and Drug Administration today alerted health care providers and patients to a potential safety concern involving an unapproved experimental product for HIV (human immunodeficiency virus, the AIDS virus)/AIDS. The sponsor of the product, Gary R. Davis, M.D., alleges that a batch of product has been stolen from a "storage facility" in Raleigh, N. C.

The sponsor has stated in a letter to the FDA that this batch of product has "the potential to be extremely dangerous" and has termed the product "contaminated medication." Dr Davis has further stated that "it is also possible that someone may try to sell this contaminated medication."

The FDA is advising health care providers and patients that goat antiserum to treat HIV/AIDS is not currently approved for the treatment of HIV/AIDS or for any human clinical study. This unapproved product, produced in goats as an antiserum against HIV/AIDS, was already the subject of a "clinical hold" by FDA, prohibiting its use until previously existing safety questions are resolved. The product sponsor himself is now warning of possible additional safety concerns about this specific batch of product. FDA urges that patients and health care providers exercise caution and be aware that there is no assurance of the safety of products which are not studied or produced in compliance with FDA regulations designed to protect patients.

Questions about this product and other unapproved investigational products may be directed to the FDA's Center for Biologics Evaluation and Research at 1-800-835-4709 or to the Office of Special Health Issues at 301-827-4460.