11 February 2006

Patients warned of clotting drug risk

Irish Examiner

11 February 2006
By Catherine Shanahan

UP TO 500 patients may have been treated with a faulty anti-clotting drug which can cause serious bleeding.
Sanofi-aventis, the manufacturers of Clexane Syringes, yesterday announced a product recall after it emerged that some syringes may contain an over-concentration of the active medicinal substance, enoxaparin, which is injected to thin the blood.

A statement from the Irish Medicines Board (IMB) warned that over-concentration of enoxaparin "has the potential to cause significant adverse reactions including an increased risk of serious bleeding".

Since the affected product entered the Irish distribution chain on November 22 last, the IMB has been notified of one adverse reaction. In this case, the patient suffered irregular but non-fatal bleeding.

The IMB yesterday confirmed it had notified all 46 hospitals as well as the six pharmacies which received Clexane Syringe packs from the affected batch. There were 30 batches produced with this potential problem of over-concentration of up to 50% of enoxaparin, distributed to 58 countries worldwide. Britain received five batches and Ireland received one.

The IMB said the specific Clexane Syringes, 80mg/0.8ml, distributed in Ireland, were part of batch number 28043 with an expiry date of 09/07.

The IMB confirmed the batch in question included 454 packs, each containing 10 vials of the product.

The IMB has requested all patients who have been dispensed Clexane Syringes since November 22, 2005 to do the following:

* Check if your pack is the 80mg/0.8ml strength.

* If your pack is the 80mg/0.8ml strength, check the batch number. This is a lot number printed on one side of the outer carton and on the vial label.

* If the batch (lot) number is 28043, then this pack is one of the potentially affected packs and should not be used under any circumstances.

* You should, as soon as possible, go to your local doctor for further advice and treatment.

* Any affected batches should be returned to your local pharmacy as soon as possible.

The IMB said additional batches of Clexane are available in the marketplace.

A statement from Sanofi-aventis said the recall had been voluntary as a precautionary measure.

It said the decision was taken following quality control testing and a subsequent investigation which identified the potential for over-concentration of the active ingredient in a limited number of syringes.

Enoxaparin is an anticoagulant used to prevent clot formation in veins and arteries and to treat deep vein thrombosis, pulmonary embolisms (blood clots in the lung) and patients with unstable angina.

Sanofi-aventis, the world's third-largest pharmaceutical company, has a base in Waterford where it manufacturers over-the-counter products but not Clexane syringes.

Clexane is a prescription-only medicine licensed in Ireland for the management of thromboembolic disorders (blood clotting). It is sold as Lovenox in the US and France, and has been used to treat more than 118 million patients in 96 countries since 1987.

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