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.