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CAUTION IN USE ALERT: Clexane syringes (11 June 2008)

Further to alerts from the Medicines and Healthcare products Regulatory Agency (PJ, 3 May 2008, p533, and PJ, 17 May 2008, p588) about batches of Clexane (enoxaparin sodium; Sanofi-Aventis) pre-filled syringes contaminated with over-sulphated chondroitin sulphate (OSCS), the following advice has been issued:

• There is no evidence of any specific risks to pregnant women or the developing fetus from exposure to the levels of OSCS found in some enoxaparin batches. However, on a purely precautionary basis, use of affected batches should be avoided in pregnant women.

• Prescribers should continue to avoid administering enoxaparin via the intravenous (off-label) or arterial line routes.

• To address a temporary shortage of 150mg pre-filled syringes, prescribers should consider using enoxaparin multi-dose vials, a combination of lower dose strengths of pre-filled syringes or a suitable alternative product. Adequate training should be provided to patients who self-inject, to prevent administration error.

A letter to healthcare professionals from Sanofi-Aventis (dated 6 June 2008), providing information about uncontaminated batches of 40mg syringes for pregnant patients and recommendations for administration of 150mg doses.