Baxter says US deaths unrelated to heparin quality

An investigation by Baxter International has found no evidence that the deaths of two patients treated at a US medical centre were related to the quality of its heparin products, according to the company.

The company said that an array of tests showed that the heparin used to treat the two patients, and a third who suffered serious complications but survived, was free of contamination with over-sulphated chondroitin sulphate (OSCS).

Heparin contaminated with OSCS – sourced from Chinese suppliers - was the cause of around 80 deaths in 2008 and sparked a global recall of Baxter’s heparin products. After the cases first emerged Baxter stressed that the raw material in this batch of heparin was supplied by Pfizer in the USA.

In this case heparin was supplied in premix bags, while the product affected in the 2008 scandal was supplied in vials and bottles.

Baxter said it conducted “an array of forensic and analytical tests to verify the product’s integrity, such as purity and potency testing, and to confirm that contaminants were not present.”

The company also undertook a detailed analysis of the supply chain for the product and found no discrepancies, concluding that the three cases “were isolated, institution-specific issues.”

All three patients were treated at Beebe Medical Centre in Delaware and suffered intracranial bleeding after treatment with Baxter’s drug. This is a recognised side effect with heparin, and a different complication from the allergic-type reactions and severe low blood pressure seen in patients exposed to tainted heparin in 2008.

The hospital brought the three cases to the attention of the company and the US Food and Drug Administration (FDA) on May 8.

“Following extensive product testing and further medical evaluation, we are confident that the events at Beebe Medical Center are unfortunate, isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” said Camille Farhat, general manager of Baxter Pharmaceuticals & Technologies, in a statement. 

Baxter currently faces a number of heparin lawsuits over the tainted heparin case, which claim that the firm failed to take sufficient steps to ensure the purity of their product and did not have effective quality control measures in place to protect the public.