Class 4 Drug Alert (Caution in Use): Low molecular weight heparin - Enoxaparin Sodium ("Clexane") pre-filled syringes

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Dear Healthcare Professional,

MHRA has recently been informed that some batches of Enoxaparin Sodium (Clexane) pre-filled syringes with low levels of Over-Sulphated-Chondroitin-Sulphate (OSCS) have been distributed in the UK over a period of 4 to 6 weeks. There is no evidence that these low levels of OSCS have led to adverse reactions.

It is expected that new and uncontaminated Enoxaparin Sodium (Clexane) stock will become available from June 2008. In the interim period, precautionary advice is being issued to minimise any risk of adverse reactions.

Withdrawal of the contaminated Clexane products could lead to a shortage of low molecular weight heparins.The Commission on Human Medicines has considered the matter and has recommended the continued supply of this product despite the low level contamination.

Prescribing advice

• 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 or patients should report adverse reactions relating to any Heparin and Enoxaparin Sodium (Clexane) products via the Yellow Card Scheme.

We currently have no similar concerns with other Heparin products in the UK but continue to keep the situation under close review.

Sources of additional information
3.1 For medical information relating to Enoxaparin Sodium (Clexane) products telephone Sanofi-Aventis medical information department on 0800 281973.

3.2 For reporting suspected defects in medicines telephone the MHRA medicines defect centre (DMRC) on 0207 084 2574.

3.3 For questions about adverse event reports and the Yellow Card scheme telephone the MHRA Central Enquiry Point on 0207 7084 2000 or see the website www.yellowcard.gov.uk

The scope of this notification covers both Originator products and products which are parallel imports.

Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.

Yours faithfully,

Ian Holloway

MHRA DMRC Manager

 

MHRA Distribution (further recipients by cascade): Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)