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WASHINGTON - EXPANDING the scope of its heparin recall, the US government sent letters to 82 medical device makers yesterday warning them to withdraw stents, catheters and other products that may be coated or may contain the contaminated blood thinner.
The move came as the Food and Drug Administration (FDA) tripled the number of deaths it said could be linked to the use of a contaminated form of heparin, distributed in the United States market by Baxter International and other manufacturers.
Heparin, used to prevent the formation of more clots in blood, is administered to patients undergoing dialysis or heart surgery.
Batches of shipments arriving from China were recently found to be contaminated with 'over-sulfated chondroitin sulfate', prompting the FDA to recall the product from the market.
The FDA said it has been investigating more than 1,200 reports of allergic reactions from the use of heparin, and has received 103 reports of deaths in patients administered the blood thinner since January last year.
New data posted on the FDA's website showed that from January last year through February this year, 62 deaths were reported among patients that could be linked to allergic reactions to the tainted heparin. This was a surge from the 19 deaths reported previously during the same period.
FDA spokesman Karen Riley said there was a 'sudden jump' in incidents involving heparin between last November and February this year, with 47 reports of deaths.
In warning makers of devices coated with the substance, the FDA said it wanted to make sure none of these products has heparin from the contaminated batches - which have since been recalled.
The contaminant was detected by the FDA on March 5 in heparin injections sold by Baxter International.
It was found to be derived from animal cartilage not approved for use in medicine, said the FDA. The agency is now trying to determine whether it was this contaminant that was responsible for the side effects such as quickening heartbeats and dizziness experienced by patients.
As the first reports of side effects trickled in, Baxter, the major supplier of heparin in the US, pulled out nearly all its products from the market in February.
Baxter spokesman Erin Gardiner said the company believed that four deaths may be linked to its version of heparin.
Baxter and its supplier, Scientific Protein Laboratories (SPL) of Waunakee, Wisconsin, have blamed the contamination on Chinese companies that provided raw heparin to an SPL manufacturing plant in China.
The recall has since spread to other heparin makers in the US, Germany and Japan, and has also prompted worldwide investigations.
Imports of heparin have been halted, and the FDA has initiated an investigation into why large quantities of an unapproved chemical were found in supplies of the drug, and whether the contamination by suppliers in China was accidental or deliberate.
Meanwhile, the Chinese Health Ministry on Tuesday urged medical institutes nationwide to administer strict checks on the medicine they source and to make sure the origin can be traced later, state news agency Xinhua reported.
The ministry also instructed medical institutions to closely observe patients who receive heparin treatment and immediately report any suspected adverse cases.
REUTERS, LOS ANGELES TIMES- WASHINGTON POST, AGENCE FRANCE-PRESSE
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