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CAUTION IN USE alert: Clexane syringes — use of contaminated stock (1 May 2008)

Some batches of Clexane (enoxaparin sodium; Sanofi-Aventis) prefilled syringes containing low levels of over-sulphated chondroitin sulphate (OSCS) have been distributed in the UK over a period of four to six weeks.

The Medicines and Healthcare products Regulatory Agency believes there is no evidence that these low levels of OSCS have led to adverse reactions. It adds that withdrawal of the contaminated Clexane products could lead to a shortage of low molecular weight heparins.

As a result, the Commission on Human Medicines has considered the matter and has recommended the continued supply of this product despite the low-level contamination.

The following advice has been issued, covering both UK and parallel-imported stock:

• Enoxaparin is a very important therapy and it is essential that patients continue to receive it as prescribed by their doctor.

• As there is no evidence of any specific risks, and to maintain supplies, product on the UK market should continue to be used.

• Purely as a precaution, intravenous and arterial administration of enoxaparin should be avoided if possible. If given by these routes, suitable emergency treatment should be available and patients should be closely observed for signs of possible hypotensive or allergic reactions.

Healthcare professionals and patients are requested to report adverse reactions resulting from the use of any heparin or Clexane products via the yellow card scheme

Medical information is available from Sanofi-Aventis on 0800 281973.

It is expected that new and uncontaminated Clexane stock will become available from June 2008.