Tainted Blood Thinner Seized by US Marshals in Ohio

By Anna Boyd
14:00, November 7th 2008
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Tainted Blood Thinner Seized by US Marshals in Ohio

The scandal around tainted heparin is again in the spotlight, as federal officials said Thursday that they have seized some of an Ohio company’s supplies of contaminated blood thinner containing material from China.

Heparin, an injectable drug used to prevent harmful clots from forming in blood vessels during kidney dialysis and heart surgery, has been connected to nearly 250 deaths and about 800 severe allergic reactions since the beginning of the year. In April, an FDA investigation revealed that the heparin was contaminated with a synthetic chemical compound known as over-sulfated chondroitin, which is cheaper than heparin, but mimics it. FDA said that Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, is the source of the contaminated heparin. Since the heparin contamination was first reported late last year, the FDA has initiated 13 recalls of contaminated medical products heparin from several companies.

Now, the FDA sent US marshals to seize 11 lots of the blood-thinning drug made by Celsus Laboratories Inc of Cincinnati, which distributes heparin to drug and medical-device manufacturers both in the United States and internationally.

The Celsus products involved were Heparin Sodium and Heparin Lithium. Heparin Sodium is the form given directly to patients while Heparin Lithium is used to coat medical devices, such as blood-collection tubes, to keep blood from clotting on them. Over two pounds of Heparin Sodium and about 31 pounds of Heparin Lithium were seized, both being worth about $112,000.

“These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin's anticoagulant activity,” said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs, in a news release.

The seizure “will help prevent this contaminated heparin from finding its way into the marketplace,” he added.

In fact, the seizure was ordered because Celsus failed to take sufficient action to assure an effective recall. The company had sent a letter to its customers telling them its heparin was contaminated but the FDA wanted the company to physically recall the product because of the danger it presented to patients. The company was informed that its response was inadequate during an April 2008 inspection and again by letter in early May, the FDA said

Moreover, the agency said it has notified Australian, Canadian, European Union, Japanese and other international authorities of shipments of contaminated heparin from Celsus. In fact, the agency said it has also advised manufacturers who might have bought heparin from Celsus to contact them to make sure they don’t have any of the contaminated heparin. “The product does not meet acceptable quality standards,” the agency said.

A representative for Celsus refused to comment on the issue.



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