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Australia's medicines regulator, the Therapeutic Goods Administration, is today recalling an additional batch of the anticoagulant (blood-thinning) medicine Clexane (enoxaparin) which has been found to contain the contaminant over-sulphated chondroitin sulphate (OSCS). This is in addition to five batches of the product recalled on April 22nd.
The TGA has been informed by the supplier of Clexane, sanofi-aventis Australia, that this recall applies to one batch of Clexane 80mg, with batch number 08018.
Patients who use Clexane on prescription should check with their doctor or pharmacist to determine if their supply of Clexane is affected by the recall of this additional 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 six batches of the low molecular weight heparin product Clexane. On 22 April 2008, five of these batches were quarantined pending further assessment. An additional batch of Clexane strength has since been found to contain the contaminant. This additional batch is:
| Name | Batch number |
|---|---|
| Clexane 80 mg | Batch No. 08018 |
The affected batches identified previously 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 |
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 continue to continue to quarantine the affected batches of Clexane so no patients are put at undue risk. A full analysis of the clinical significance of the contaminant in Clexane is continuing.
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.
Sponsors have advised that 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 working with suppliers of heparin to source additional heparin products. However today's recall in Australia, in addition to the previous recalls of Clexane, together with ongoing supply problems of heparin products worldwide, could result in a shortage of the product in Australia in the future.
The TGA and the Department of Health & Ageing have been 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. On 16 May 2008 Consensus Guidelines were released by the Department of Health & Ageing on measures to manage a potential shortage of anti-coagulant medicines containing the blood thinning agent, heparin.
Around the world regulatory agencies have varied in their responses to the issue of heparin contamination, 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:
- 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 and wholesalers are advised to return any product from affected batches to the manufacturer.
The TGA is continuing to work closely with international regulators and Australian clinicians to develop the most effective strategies to allow safe supply of heparin products, and will continue to keep the medical profession and consumers fully briefed as the situation unfolds.