EMEA measures to manage heparin use

The European Medicines Agency (EMEA) has reviewed the risks associated with the use of heparin medicinal products contaminated with oversulphated chondroitin sulphate (OSCS; Marketletters passim). Heparins are used to prevent and treat blood clots. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that:

- OSCS has been found in unfractionated (standard) and low-molecular-weight heparin; - there is a link between contamination with high levels of OSCS and serious side effects seen in some patients who have received tainted standard heparin. All batches of affected products have been identified by regulatory authorities worldwide and removed from the market; and - low levels of OSCS have also been identified in some batches of the low-molecular-weight heparin enoxaparin. However, no similar side effects have been observed when enoxaparin has been used. A total removal of contaminated enoxaparin from the market in countries where it is used would lead to a shortage of supply and patients would not be able to continue their treatment.

The Committee concluded that doctors can continue to use enoxaparin with low levels of OSCS temporarily until the situation is resolved. However, a series of measures should be put in place to minimize the risk of side effects. The CHMP also looked at long-term approaches to minimize the possibility of future contamination. It recommended any inspection of the heparin supply-chain requires a coordinated approach between European and international partners and that modifications to the existing framework of control should be explored.