It’s like a bad dream happening all over again – people falling ill or dying after receiving doses of the blood thinner heparin. In 2007, tainted doses of heparin killed more than 80 Americans and injured hundreds more. And while investigations into the cause continue, the culprit was found to have been over-sulfated chondroitin sulfate (OSCS) a heparin-mimicking contaminant that made its way into batches of heparin that were manufactured in Baxter International’s China plant.
Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. Could this be a repeat of the deadly contamination that harmed so many in 2007? The vials of heparin were traced back to Baxter, however these doses were manufactured in Ohio, not China, the drug maker contends.
Last year’s OSCS contaminant caused victims to suffer severely low blood pressure. This new reaction involves intracranial bleeding. Investigations by both Baxter and the Food and Drug Administration (FDA) followed and early findings indicate there is no trace of OSCS in the heparin used. Now Baxter says it is confident that the events at the Delaware hospital were “isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” a Baxter spokesperson told the Reuters news organization.
According to Baxter, it obtained samples from the lot in question as well as lots produced before and after the lot in question. Testing on those lots confirmed that the product’s formulation was within specifications and met all requirements. The FDA backed up Baxter’s contention: “We don’t see a quality problem with the product,” an FDA spokesperson said.