US government regulators told doctors to switch from using a blood thinner made by Baxter International, following hundreds of reports of allergic reactions.
The Food and Drug Administration said it has received 350 reports in 2008 of side effects, including vomiting, nausea and difficulty breathing. Four people died while taking the drug, though the agency said it wasn't clear if the drug was to blame. In all of 2007, the agency received 100 reports of problems with the drug.
The heparin manufactured by Baxter International, is not available in South Africa. A product called Thrombophop, manufactured by Aventis, is available instead.
Baxter withdraws productThe company said the problems were not limited to the nine lots in the recall
Government inspectors are examining Baxter's manufacturing sites to locate the source of the problems, FDA said.
Before the FDA's announcement, Baxter said it would stop manufacturing multiple-dose vials of its injectable heparin. Last month, the Deerfield, Illinois-based company voluntarily recalled nine lots of the vials after finding out dialysis patients had allergic reactions to it. Their problems ranged from dizziness and fainting to racing heart beat.
Baxter said it would cooperate with the investigation.
Agency officials considered a recall, but said they decided not to because it would create a dangerous shortage of the drug. Baxter accounts for about half the US supply.
Instead, the FDA warned doctors to use it with "caution when medically necessary."
"There's going to be a shortage problem in immediate and long term future due to the suspension of manufacturing by Baxter," said John Jenkins, an FDA office director.
Kidney-failure patients receive heparin to prevent clotting of blood during the dialysis process. The drug is also used in certain types of heart surgery.
Warning to doctors
FDA said nearly all the reported problems have been in dialysis patients who received high doses of heparin over a short time. Agency scientists said doctors who continue to use the drug should use the lowest doses possible and administer it slowly.
Baxter sold about 35 million vials of injectable heparin in the US last year, with revenue of $30 million (R234 million).
FDA officials asked APP and other pharmaceutical companies to
increase production of heparin to offset the lost Baxter product. – (Matthew Perrone/Sapa/AP)
Heparin may pose heart risk