Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-mimicking contaminant that can cause serious allergic reactions in humans.
The new standards were proposed by scientists with U.S. Pharmacopeia, a nonprofit public health group that sets standards for the quality, purity, strength and consistency of medicines. A spokesperson with the group says the new standards are the best as scientifically possible at this time.
The revisions for testing the popular blood thinner were first requested by the FDA when the contaminant was identified in March. The changes are expected to go into effect on August 1 and include three identification tests and screening for organic impurities.
Baxter was one of the leading manufactures of heparin, producing half of the injectable heparin sold in the U.S. and generating about $30 million in sales each year. Baxter stopped sales of heparin last year and has yet to resume selling the anti-coagulant. The company is facing numerous lawsuits from families affected by the tainted heparin.