The European Medicines Agency has reportedly recalled certain batches of Baxter’s blood thinner heparin in France, Italy and Denmark, over fears of potential contamination with over-sulphated chondroitin sulphate.
According to media reports, the countries are the latest in Europe to pull batches of heparin as a precautionary measure, following in the footsteps of Germany and Switzerland, which removed the product earlier this month on reports of side effects in patients taking the drug.
Last month, Baxter was forced to temporarily suspend production of heparin at its plant in China following an increase in serious allergic reactions and low blood pressure in patients receiving high ‘bolus’ doses of the drug, including around 20 possible patient deaths.
US regulators have since confirmed that the drug was contaminated with a chemically-modified form of chondroitin sulfate, a popular dietary supplement for joint pain derived from animals altered to mimic the actions of the drug, and that the contaminant has been traced back to factories in China.
Heparin is derived from pig intestines and has been marketed in the USA since the 1930s.
