Acute Coronary Syndrome
Enoxaparin now affected by heparin contaminant
April 25, 2008 | Sue Hughes

Paris, France - The contaminant found in heparin has now also been identified in some batches of the low-molecular-weight heparin enoxaparin (Lovenox/Clexane), the manufacturer, Sanofi-Aventis, has reported. But no increase in adverse reactions has been seen with the product.

The company told heartwire that it has put in place screening tests for the contaminant, oversulfated chondroitin sulfate, which has been detected "in very small concentrations" in a few batches. Sanofi-Aventis spokesperson Salah Mahyaoui said that the company has alerted all worldwide health authorities of its findings and the batches affected "as a precautionary measure," and different countries have taken different actions.

So far, three countries—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. Other countries have said that no action is necessary at this time, as there have been no adverse reactions reported and the contaminant is present in such low concentrations, Mahyaoui added.



Your comments
Enoxaparin now affected by heparin contaminant
# 1 of 2
May 07, 2008 01:32 PM (EDT)
carl trygstad
AEs not yet reported
As the drug is given sq there may not be AEs of the usual type. The AE will be from lack of efficacy which will be difficult to detect or measure.
# 2 of 2
May 07, 2008 05:59 PM (EDT)
Melissa Walton-Shirley
Hope you are wrong
Well, that's encouraging (not). Can you elaborate a little more on your thoughts here?
Melissa

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