Drug Controversy

Germany Recalls Blood-thinner Heparin

Germany has recalled supplies of the blood thinner heparin following reports of severe reactions, expanding a withdrawal of the drug linked to 19 US deaths, the Food and Drug Administration (FDA) said.

The recall brings into question the safety of European supplies of the drug, which become target of the US investigation after a spike in fatalities and severe reactions in some patients taking heparin sold by Baxter International Inc. German authorities do not expect a shortage of the drug, FDA said. The FDA began probing Baxter's heparin several weeks ago, after it was linked to four deaths and hundreds of severe reactions, such as breathing problems and rapid drops in blood pressure. The FDA identified a contaminant that may be linked with the drug's problems.

Some 19 fatalities have now been associated with use of the drug in the US, according to FDA. However, all the deaths have not been linked to a specific drug maker. The other major US heparin supplier, APP Pharmaceuticals Inc, has ramped up production to avoid a drug shortage. No fatalities were seen in Germany, and 'less than 100' severe reactions led to the recall, the FDA said. The German product manufacturer, Rotexmedica GmbH, could not be immediately reached for comment. Heparin is derived from pig intestines. It is used in dialysis and heart procedures, among other surgeries, to avoid blood clots.

FDA officials also advised companies and countries to begin using a sophisticated testing technique which the agency uses to find the potential contaminant, to test all heparin on the market. Baxter's main supplier is Wisconsin-based Scientific Protein Laboratories LLC (SPL), which has a major facility in China, a main subject of FDA's investigation. China's reputation has been tainted after health scares with pigs and massive recalls of pet food and children's toys containing lead paint.

The FDA conducted about 13 inspections at Chinese plants in 2007, versus 65 at plants in India. China has 714 facilities against India's 410, according to the GAO report. Baxter has recalled most of its US supplies of the drug.

Reuters