The Food and Drug Administration has 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.