South Africa has become the first country to approve an artificial blood substitute for use in transfusions.
The solution, Hemopure, acts like red blood cells, carrying oxygen to body tissues. Carl Rausch, the chief executive of Biopure, which developed the product, said the South African medicines control council approved the product
on Monday to treat acute anaemia in surgery patients.
Hemopure is made with purified haemoglobin from cows' blood. The purification process removes all other proteins, preventing the transmission to humans of bovine diseases such as BSE, which is caused by prions, a type of mutated protein. Some researchers have, though, raised fears that any medical product made from animals presents a risk of introducing new diseases to people.
The solution could be used with patients of any blood type and would eliminate the risk of catching infectious diseases including HIV from tainted transfusions, Mr Rausch said.
Donor blood must be refrigerated and can only be stored for 42 days, while Hemopure can be stored at room temperature and lasts for two years. Side- effects include slightly increased risk of stomach pain, weakness, hypertension, jaundice and nausea. But its problems were no greater than those linked to normal blood transfusions, Biopure said.
Dr Luc Noel, co-ordinator for blood transfusion safety at the World Health Organisation in Geneva, said Hemopure could be an important substitute for transfusions in developing countries with shortages of safe blood, provided it was reasonably priced. He also cautioned that its use must be closely monitored to detect unforeseen side-effects. "If there is any alternative that is safer than the potential risks of transfusions, then it should be used," he said.
Dr Richard Friedland, the chief executive of Netcare, which jointly holds the Hemopure licence in South Africa, declined to say how much the product would cost. He said developing countries would pay less for Hemopure than richer countries.
Hemopure is the first blood substitute approved for use in humans. Biopure's blood substitute for dogs is already licensed in Europe and America. The company plans to apply for approval of Hemopure in Europe and the US this year.
- INDEPENDENT
