Clexane recalled

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.

While there have been no Australian reports of adverse events of the type reported in the US associated with heparin products, the TGA decided to quarantine the affected batches of Clexane so "no patients are put at undue risk".

"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," the TGA said in a statement.

The regulator said 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.

It also warned that the 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.

Pharmacists have been 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.