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Clexane (enoxaparin): Recall of blood-thinning medicine

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22 April 2008

Australia's medicines regulator, the Therapeutic Goods Administration, has recalled five batches of the anticoagulant (blood-thinning) medicine Clexane (enoxaparin) due to the detection of an impurity in the affected batches.

Patients who use Clexane on prescription should check with their doctor or pharmacist to determine if their supply of Clexane is from a recalled batch.

Doctors should ensure their patients return any affected product to their pharmacy or clinic.

In the event of difficulties obtaining uncontaminated batches of Clexane, alternative anticoagulants such as Fragmin (dalteparin sodium), unfractionated heparin or oral anticoagulants should be prescribed as clinically appropriate.

Clexane, and other heparin containing products, are life-saving medicines, essential for patients for heart surgery, joint surgery, in patients with kidney failure and numerous other clinical conditions.

The TGA has required testing of all heparin containing products in Australia since March 2008, following the identification of a contaminant known as "over-sulphated chondroitin sulphate (OSCS)" implicated in several severe allergic reactions in the USA and Europe.

As a result of this testing contamination with OSCS has been detected in five batches of the low molecular weight heparin product Clexane. These batches have been quarantined pending further assessment.

The affected batches are:

Name Batch number
Clexane 20 mg Batch No. 02115
Clexane 40 mg Batch No. 04526
Clexane 80 mg Batch No. 08009
Clexane 100 mg Batch No. 01007
Clexane 100 mg Batch No. 01011

The quarantining of the affected product is the initial step in protecting public health while a full analysis of the clinical significance of the contaminant in Clexane is completed.

To date, in Australia, there have been no reports of adverse events of the type reported in the United States associated with heparin products. Nevertheless, the TGA has decided to quarantine the affected batches of Clexane so no patients are put at undue risk at this time.

People having surgery or requiring treatment with heparin products for other reasons at present should be given either Clexane from batches other than those affected by contamination, the alternative low molecular weight heparin known as Fragmin, or an unfractionated heparin product.

Supplies of both intravenous heparin and Fragmin available in Australia have been tested and are free of the contaminant affecting these batches of Clexane.

The TGA is endeavouring to procure alternative supplies of heparin products. However today's recall in Australia, together with ongoing supply problems of heparin products worldwide, could result in a shortage of the product in Australia in the future.

The TGA is currently working with clinical experts from around the country, suppliers and international regulatory counterparts, to determine the best way to ensure patients have safe access to these treatments.

Responses from regulatory agencies around the world have varied, with some agencies initiating recalls and others continuing to allow contaminated product to remain in the market, based on the view that in many clinical settings the benefits of continued use of these blood thinning agents outweigh the possible risks from contamination.

At this time the TGA's advice is as follows:

Patients who use Clexane on prescription are advised to check with their doctor or pharmacist to determine if their supply of Clexane may have been affected. Patients should not discontinue treatment without consulting their doctor. After consulting their doctor they should return their supply of Clexane to their pharmacy if it is from one of the affected batches, and use the alternative anticoagulant prescribed by their doctor.

Batch numbers are located on the side flap of the carton containing the Clexane.

Doctors are asked to ensure their patients return any affected product to their pharmacy or clinic.

Pharmacists are advised to return any product dispensed from affected batches to the manufacturer, and to quarantine any affected product not yet dispensed on site pending further advice from the TGA.

Wholesalers are advised to quarantine affected batches of Clexane on site pending further advice from the TGA.

The TGA is working closely with international regulators and Australian clinicians to develop the most effective strategies to allow safe supply of heparin products, and will keep the medical profession and consumers fully briefed as the situation unfolds.