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Federal drug regulators have seized batches of the tainted blood thinner heparin from a Cincinnati manufacturer that used a Chinese-made ingredient linked to 81 U.S. deaths earlier this year.
The Food and Drug Administration (FDA) said yesterday that it took 11 lots of heparin from Celsus Laboratories that was contaminated with over-sulfated chondroitin sulfate (OSCS), a chemical used only to make fake blood thinner. The ingredient mimics heparin's anti-clotting properties but can cause severe allergic reactions and dangerously low blood pressure, according to reports the agency received beginning in January.
No patients were harmed by the tainted Celsus products, which were to be used in medical devices, not as injections, FDA spokeswoman Karen Riley said today.
Celsus informed its customers that the products were contaminated after they were shipped between January and April, but didn’t tell buyers to destroy or recall them if they'd already been embedded in the companies' devices, Riley said. The tainted heparin was sold to universities, research, chemical and research-supply facilities in the U.S, Japan, Canada, Australia and Europe. "This was a contaminated product, and we don’t think that [Celsus] did enough," Riley said. "We decided to seize the remainder and destroy it."
Facilities that may have bought heparin from Celsus should contact the company to make sure they're not using products from the seized lots, the FDA says. A receptionist who answered the phone at Celsus this morning said the company had no comment.
The FDA has issued 13 recalls of tainted heparin products so far this year. Scientists are racing to develop safer, synthetic versions of the anticoagulant to reduce American dependence on China for the drug, which is traditionally made from a complex carbohydrate derived from pigs’ intestines.
Riley declined to give a number for consumers or businesses to call about the heparin seizure, saying Celsus had notified its customers about the tainted product.
Image by iStockphoto/Bogdan Pop