Germany follows US example and recalls heparin batches

Germany has ordered a recall of the blood-thinner heparin, made by Rotexmedica, which confirms comments made last night by the US Food and Drug Administration.

The Reuters news agency quotes Ulrich Hagemann of Germany’s Federal Institute for Drugs and Medical Devices as saying that "there is suspicion that batches of heparin produced by Rotexmedica (a subsidiary of France’s Panpharma) have been contaminated". He added that the drug could be using active ingredients from China, saying that three severe cases of allergic reaction had been reported so far.

The recall brings into question the safety of European supplies of heparin, which is being investigated in the USA after the FDA began reviewing Baxter International's heparin products last month after they were linked to four deaths and hundreds of severe reactions, such as breathing problems and rapid drops in blood pressure.

Baxter International temporarily suspended production of certain doses of heparin after those reports and the FDA advised doctors to switch suppliers. The probe took on another slant with the news that the facility in China where some batches of the blood-thinning agent were being produced had not been inspected by the agency.

Now the FDA has also said that it has identified a contaminant that may be linked with the drug's problems. 19 fatalities have now been associated with use of the drug in the USA, though none of the deaths have been linked to a specific drugmaker.