December 22, 2000FDA Issues Safety Alert On Stolen,
Unapproved Treatment for HIV/AIDS
DC (SafetyAlerts) - 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
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
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.
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