Important note: Information in this article was accurate in 1987. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - December 10, 1987
Susan Cruzan - (301) 443-3285
The product was made using an old heat treatment. Six patients receiving three lots -- B71308, B71408 and B71508 -- distributed only in Canada have tested positive for antibody to HIV, the virus that causes AIDS. It is not known if the product caused the positive reactions but the Canadian government withdrew the product as a precaution.
FDA Commissioner Frank E. Young, M.D, Ph.D., advised that although all the cases involved lots distributed only in Canada, other similarly processed lots are being withdrawn as "an extra precaution." He said, "Hemophilia patients who have the Armour product in their homes should check with their doctor, clinic or supplier to see if it is from any of these 208 lots."
The H.T. Factorate Antihemophilic Factor involved was manufactured with a process in which the dry product was heated at 60 degrees centigrade for 30 hours to inactivate the AIDS virus. Newer Armour products are processed differently.
The products being withdrawn in the United States and internationally have a six digit code beginning with A or B and have expiration dates up to Dec. l988, but not all products with expiration dates before Dec. l988 are involved. Armour estimates that only 2,000 to 5,000 doses currently remain on the market here and abroad.
FDA is working closely with the company and the Canadian government to clarify the problem.
Physicians, nurses and patients seeking additional information may use a touch-tone telephone during working hours to call (800) 533-6165 (Pennsylvania call 800-422-0566). When they hear a recorded message, they should then use the extension 7070, 7074 or 7077. People with rotary dial telephones should call Spencer Johnson (215) 540-8109 collect.
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SOURCE: Food and Drug Administration (FDA).
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