All heparin products on the Danish market have been tested for the impurity oversulfated chondroitin sulfate (OSCS). The products were tested after it came out that the use of heparin products (most of which are produced by the American company Baxter) has caused some serious adverse reactions in the US.
Heparin is a blood-thinning (anticoagulant) medicinal product, which is primarily dispensed as injections at hospitals and during operations to prevent the blood from clotting. In the fact box to the right, you can find our previous notification on heparin from 26 March 2008.
Analyses of heparin products on the Danish market show that:
- The impurity was not found in LEO Pharma's products Heparin Leo® and Innohep®.
- The impurity was not found in Amgros I/S' product Heparin®. As regards Sanofi-aventis' product Klexane®, the impurity was not found, except from a single batch no. 5140, 100mg/ml, 10x0.8ml, in which OSCS was discovered in very small quantities. The batch has been placed under quarantine and must not be used.
- For Pfizer's product Fragmin®, the impurity has not been found in the tested batches, but not all batches have been tested yet. The Danish Medicines Agency has therefore instructed Pfizer to withdraw all batches that have not been tested.
These are the nine batches in question:
10896A01 Fragmin 12500 anti-Xa IE/ml, 25x0.2ml
10990A01 Fragmin 12500 anti-Xa IE/ml, 10x0.2ml
74319G51 Fragmin 25000 anti-Xa IE/ml, 5x0.4ml
74333D51 Fragmin 25000 anti-Xa IE/ml, 5x0.4ml
74327A51 Fragmin 25000 anti-Xa IE/ml, 5x0.5ml
74329C51 Fragmin 25000 anti-Xa IE/ml, 5x0.6ml
74329B51 Fragmin 25000 anti-Xa IE/ml, 5x0.6ml
74321F51 Fragmin 25000 anti-Xa IE/ml, 5x0.72ml
74312B51 Fragmin 25000 anti-Xa IE/ml, 10x0.3ml
The Danish Medicines Agency has only received one adverse reaction report related to heparin. The adverse reaction in the report is not classified as serious. The Danish Medicines Agency is currently investigating the case.
For further information, please contact Anne-Marie Vangsted, Director of Inspections, tel. +45 4488 9315.
Danish Medicines Agency, 24 April 2008
