South Africa becomes first country to approve blood substitute

Tuesday, April 10th 2001, 12:00 am
By: News On 6

JOHANNESBURG, South Africa (AP) _ South Africa has become the first country in the world to approve a solution that can be used in place of blood in transfusions, a health care company announced Tuesday.

The solution, Hemopure, acts like red blood cells, carrying oxygen to the body's tissues. South Africa's Medicines Control Council approved it Monday afternoon to treat acute anemia in surgery patients, said Netcare, which is licensed to distribute the product.

``Hemopure represents a new and potentially lifesaving treatment approach for providing immediate oxygen-carrying support when there is a need or preference to avoid red-blood cell transfusion,'' said Dr. Lewis Levien, a vascular surgeon at Netcare's Milpark Hospital in Johannesburg.

Hemopure is made using hemoglobin from cows under a technique that prevents the transmission to humans of bovine diseases including mad cow disease, according to the release.

The blood substitute can be used with patients of any blood type and would eliminate the risk of catching infectious diseases _ including HIV _ from tainted blood transfusions, the release said. Donor blood must be refrigerated and can only be stored for 42 days, while Hemopure can be stored at room temperature and last for two years.

Side effects include slightly increased risk of stomach pain, weakness, hypertension, jaundice and nausea.

The blood substitute was developed by Biopure, a biotechnology company based in Cambridge, Mass. It is licensed in South Africa to Tshepo Pharmaceuticals, which is jointly owned by Netcare and Community Healthcare, a holding company with several health care related investments.

Hemopure is the first blood substitute approved for use in humans. Biopure has already received approval in the United States and Europe for a blood substitute for dogs.

Biopure plans to file a marketing application this year for approval of Hemopure in the United States and Europe.