UK issues contaminated heparin warning

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has warned that contaminated heparin products are still being encountered in the market.

The agency has issued a class 4 alert  to physicians and pharmacists advising that low levels of over-sulphated chondroitin sulphate (OSCS) have been encountered in the active pharmaceutical ingredient (API) used to manufacture heparin products in the UK.

OSCS was the contaminant that caused the deaths of more than 200 people around the world in 2008. It is thought the OSCS was substituted for the genuine active pharmaceutical ingredient (API) by a manufacturer in China because it can mimic heparin on routine testing.

The MHRA has advised caution when prescribing the affected products – sold by CP Pharmaceuticals and Wockhardt – but consider that the levels of OSCS (at 0.6 per cent) are too low to warrant a recall.

Taking the products off the market could cause “a potential out-of-stock situation which would have adverse clinical consequences,” according to the MHRA.

The agency maintains that there is no evidence that levels this low can cause the serious side effects seen in the 2008 cases, where the OSCS contamination was at levels of 17 to 21 per cent.

That said, the MHRA notes the healthcare practitioners should use care when prescribing the products, and points out that there seems to be a lower risk of reactions when heparin is delivered by subcutaneous rather than intravenous injection.

As a precaution, the MHRA has asked that batch details are recorded routinely in the patient’s notes when any heparin product is prescribed.

The contamination, which affected API used in the manufacture of 31 batches of heparin sodium distributed in the UK, was identified using a more sensitive test method than was previously available.