WASHINGTON (Reuters) - Chinese investigators have concluded that a contaminant found in the blood-thinner heparin was not the cause of deaths and allergic reactions related to the drug in the United States, Chinese health officials said on Monday.
U.S. Food and Drug Administration officials have previously said the contaminant, which mimics the blood-thinning effects of heparin, is the focus of their investigation but have not drawn a final conclusion.
Baxter International Inc recalled most of its heparin products in February. Its drug is made with ingredients from China.
The FDA says as many as 62 deaths and hundreds of adverse reactions have been linked to heparin, including Baxter’s product. The drug is used in kidney dialysis and various surgeries to prevent blood clots.
But Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, said his team was examining the “whole product not just the ingredients” after conducting its own tests.
Jin said Chinese investigators tested batches of heparin used by patients who reported those health problems, and only some of those batches contained the contaminant. “The over-sulfated chondroitin can therefore not be the suspected root cause of heparin ADE (adverse events),” he told reporters.
Jin and other officials said they planned to visit Baxter’s plant in New Jersey later on Monday. “They will cooperate with us, no problem,” he said.
The FDA is expected to hold a conference call with reporters later on Monday.
A spokeswoman for Baxter did not immediately return a call seeking comment.
Shares of Baxter were down 29 cents, or 0.5 percent, to $60.99 per share in afternoon trading on the New York Stock Exchange.
Separately on Monday, the FDA warned Baxter’s Chinese supplier of raw heparin for failing to ensure its manufacturing process can remove impurities.
“Your firm failed to establish appropriate specifications for identified and unidentified impurities for the heparin... your firm also failed to perform adequate tested to detect impurities,” the FDA said in a letter to Changzhou SPL Co Ltd.
FDA inspectors, who visited the Changzhou SPL facility in China February 20-26, also faulted its equipment and said the company did not properly evaluate its own suppliers.
The FDA earlier failed to inspect the company before approving Baxter’s heparin because of a mix-up with Changzhou SPL’s name.
Changzhou SPL spokesman Alexander Shaine said the FDA’s letter did not reflect the company’s actual manufacturing processes but said it would cooperate with the agency.
The Chinese health officials visiting the United States said they were focused more on Baxter, not Changzhou SPL.
While over-sulfated chondroitin sulfate is not a natural part of heparin, Jin said it could not have caused all the reported reactions. Other contaminants, problems with the device used to inject the drug, or health factors with the patients who used the drug could also be factors, he said.
Another Chinese official, Li Xuewang of Huazhong University of Science and Technology’s Union Hospital, complained of a lack of details from the FDA. He said Chinese investigators needed more information on the patients involved but were told it could take several months.
“The disease pattern is very complicated. Many causes can present the same clinical symptom(s),” Li said.
Reporting by Susan Heavey, editing by Tim Dobbyn