Government
FDA to investigate deaths linked to Chinese-ingredient based heparin
By Sue Mueller
Feb 14, 2008 - 10:54:05 AM

THURSDAY FEB 14, 2008 (Foodconsumer.org) -- Baxter's heparin made of an active ingredient manufactured in China has been linked to four deaths and illness in more than 350 patients, The New York Times reported today.

Without knowing what exactly caused these illnesses and deaths, the Food and Drug Administration has decided to inspect he Chinese factory as well as a finishing plant in New Jersey as soon as possible.

Heidi Robello, an FDA spokeswoman was cited as saying it was unknown whether the Chinese plant was actually the source of the problem that caused the high number of incidents associated with use of heparin.

Heparin, made from pig intestines, has been used as a blood thinning agent to prevent the blood from becoming clots.  It is widely used in dialysis, heat surgery and chronic care hospitals, the times reported.

Heparin supplied by Baxter International, which has plants both in China and the United States, accounts for half of the U.S. total on the market.

Citing the commercial trade secret, the company didn't disclose the name of the Chinese company that has supplied for the past 20 years the active ingredient used in heparin.

The inspection of foreign drug plants has proved difficult. 

The Government Accountability Office (GAO), an independent arm of Congress, recently reported that at its current inspection pace, it would take at least 13 years to inspect every foreign drug factory that exports products to U.S. drug makers.

The GAO also said the FDA does not have much of an idea how many plants outside the U.S. had been approved for exports to the United States as the agency’s computer system were "deficient", according to the times.

In response to the reports of heparin-linked deaths and incidents, Baxter was said to have initiated a recall of some of the product, but the problem remained, according to news reports.

The FDA allowed Baxter to deliver heparin that was in the midst of shipping as it feared that a complete recall of the product would result in an immediate and serious shortage of this drug.

Meanwhile the agency cautioned physicians to use as little of the Baxter's heparin as they can and use it as slowly as possible.

Additionally, the FDA advised that doctors should consider giving steroid or antihistamines along with the Baxter drug to help prevent severe allergic reactions from happening.

The reports of heparin-associated incidents have again reminded readers of the Chinese food safety scandals reported in the last couple of years.

Earlier, a pet food ingredient made in China was found to contain high levels of melamine, which was added to give an impression that the product contains high levels of proteins.  Scandals involving Chinese seafood and toothpaste have also been reported.
 
However it has yet to be determined whether the Chinese factory was at fault in the heparin-associated illnesses and deaths, the FDA was cited as saying.