Impurities found in Sanofi heparin product

-Fierce Pharma

04/25/2008 -- While heparin maker Baxter mulls whether to re-enter the market for that blood thinner, Sanofi-Aventis is announcing that small amounts of an impurity have been found in batches of its heparin injection Lovenox. Batches of contaminated Lovenox have been found in the U.K. and in Sweden, where it is sold under the name Clexane. European regulators said that there's no evidence of any risk to patients, but Sweden has withdrawn the product anyway as a precaution.

Back in Chicago, Baxter CEO is saying that the company is leaving its heparin options open. You'll recall that Baxter recall virtually all its heparin products after the med was linked to severe allergic reactions and deaths; since then, investigators found a contaminant in the problem batches and have said they suspect it was introduced somewhere along the med's Chinese supply chain.

Before deciding whether to sell heparin vials again, CEO Robert Parkinson told analysts, the company needs to understand how the product was contaminated in the first place. "We need to ensure that that supply chain is controlled as effectively as possible," he said.