FDA Issues Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDSDate: 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.