Since the beginning of the year, the US Food and Drug Administration (FDA) has recorded an increasing number of reported adverse drug reactions - some 800 reports, of which 19 involved deaths in patients - from the use of heparin. The heparin primarily came from the healthcare company Baxter. Heparin is a blood-thinning (anticoagulant) medicine, which is primarily given as injections at hospitals and during operations to prevent the blood from clotting.
Baxter uses raw heparin from a Chinese supplier. Baxter's products were recalled from the US market, and the FDA issued a public warning (Rapid Alert).
Generally accepted test methods did not show anything abnormal. The FDA has developed two new methods that revealed a contaminant in the batches having caused the adverse reactions. The FDA has not established with 100 percent surety that the contaminant is what caused the adverse reactions, however, it is highly likely to be the case.
Baxter's heparin products are not marketed in Denmark, and there has been no increase in the number of adverse reactions reports in Denmark.
Heparin with the same contaminant from other Chinese suppliers was later found in Germany and Italy.
The Danish Medicines Agency has sent letters to all manufacturers of heparin-containing products, instructing them to
- recall all heparin products that are based on raw heparin from the Chinese companies in question at once,
- submit a list of the companies that they use as suppliers of raw heparin to the Danish Medicines Agency no later than 1 April,
- test all raw heparin for contamination no later than 1 April and send the results to the Danish Medicines Agency.
All companies are already testing for contamination. Two companies have used heparin from the Chinese suppliers concerned, however, laboratory tests have shown that there is no contaminant in the products on the Danish market. Nonetheless, the contaminant has been found in one heparin raw material. Fortunately, it had not yet been used in a finished product. The Danish Medicines Agency has issued a warning to other medicinal authorities about the concrete raw material.
For further information, please contact Anne-Marie Vangsted, Director of Inspections, telephone +45 4488 9515.
The Danish Medicines Agency, 26 March 2008