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DRUG ALERT
Class 3 medicines defect informationFor distribution to physicians, pharmacists and wholesalers
| 11 June 2008 | EL(08)A/7 | Our ref: MDR 46-02/08 |
Dear Healthcare Professional,
Enoxaparin sodium("Clexane") pre-filled syringes
Correction to advice from Sanofi Aventis issued with EL(08)A/5 on 6 June 2008 for pregnant patients and advice on selective purchasing and the impact on future supplies
Batch Numbers of uncontaminated Clexane suitable for pregnant patients
The letter attached to Drug Alert EL(08)A/5 listed four batch numbers of uncontaminated 40mg Clexane pre-filled syringes recommended for supply to pregnant patients. The list included batch 04251 which we now understand has never been produced or distributed.
Batch 04351 should replace batch 04251 in the list previously circulated.
Sanofi Aventis wish to apologise for this error which we understand was present in both data supplied to the MHRA and their own communications.
Purchasing advice
We understand that some purchasers are trying to purchase stocks of Clexane pre-filled syringes that are free from OSCS contamination for all their patients. Present advice from the MHRA and CHM is that uncontaminated Clexane should be supplied to pregnant patients as a priority group.
Widespread requests for uncontaminated stocks of Clexane for use in non-pregnant patients by sub-cutaneous administration could result in supply shortages over the next few months. Purchasers are requested to refrain from selective purchasing except for pregnant patients or if there is a special clinical need.
We have previously published the CHM advice that contaminated Clexane pre-filled syringes should be avoided in intravenous and arterial administration if possible. This advice is still valid but only affects a small number of patients.
Further enquiries
If you have any medical information enquiries please contact Sanofi-Aventis medical information department on 0800 281973.
Yours faithfully
Ian Holloway
MHRA DMRC Manager
Regional Contacts for NHS Trusts and Provider Units
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Primary Care Trusts (England)
Class 3 Drug Alert (Action within 5 days): Enoxaparin sodium ("Clexane") pre-filled syringes - EL(08)A/7 
