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Pharmacy Focus

Possible Contamination of Enoxaparin (Lovenox/Clexane) Reported

Sanofi-Aventis has reported that the contaminant (oversulfated chondroitin sulfate) found in heparin has now also been identified in some batches of the low-molecular-weight heparin enoxaparin (Lovenox/Clexane). No increase in adverse reactions has been seen with the product.

Sanofi-Aventis announced that it has put screening tests in place for the contaminant, which has been detected "in very small concentrations" in a few batches, according to an April 25 article in Heartwire. A spokesperson said that the company has alerted all worldwide health authorities of its findings and the batches affected "as a precautionary measure."

To date, Australia, Sweden and Italy have requested the recall of the enoxaparin lots containing the contaminant. Other countries, including France, Belgium and Spain, have advised that the product should be given only by subcutaneous injection, as the adverse reactions seen with contaminated heparin in the US and Germany have been associated with bolus intravenous use.

According to the drug maker, distribution of the contaminated product was limited to non-U.S. (primarily European) markets. The manufacturers of Fragmin (dalteparin) state that they have not detected any contaminant in their product following FDA required inspection of raw materials sourced from China.