FDA on Monday officially linked the contaminant found in blood thinner heparin to deadly allergic reactions, a claim that Chinese officials disputed.
Jin Shaohong, deputy director-general at the Chinese National Institute for the Control of Pharmaceutical and Biological Products, expressed doubt at the Chinese Embassy in Washington on Monday because the majority of countries that received the tainted blood thinner did not see a spike in adverse reactions to the drug, according to an embassy spokesman.
Of the 11 countries where heparin contaminated with the synthetic compound oversulfated chondroitin sulfate cropped up, only the United States and Germany experienced increases in serious side effects, according to FDA.
“We have data in vitro, in the test tube in other words, as well as animal data, that shows this contaminant can trigger events that would lead to these type of reactions,” Janet Woodcock, FDA’s drug center director, said. Woodcock said the difference in the countries’ experiences could be linked to the more common practice of using larger doses than in most of Europe.
The contaminant has been linked to 12 Chinese companies along the supply chain of heparin, Deborah Autor, director of compliance at FDA’s drug center, said.
Chinese officials traveled to a Baxter International plant in New Jersey later Monday to make observations, the embassy spokesman said. Baxter produced half the supply of U.S. heparin.
FDA increased the death count linked to the drug Monday to 81, up from 62.
The House Energy and Commerce Oversight and Investigations Subcommittee is holding a hearing today on weaknesses in FDA’s foreign drug oversight.
“Without an overhaul of our foreign drug inspection procedures, the deaths associated with heparin won’t be the last casualties of contaminated drugs,” Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., said. Stupak and other committee leaders, including Energy and Commerce Chairman John Dingell, proposed a discussion draft of import safety legislation last week focused on strengthening FDA’s inspection efforts.
Woodcock pointed out Monday the oversulfated chondroitin sulfate could not be detected through normal testing, but instead, FDA had to develop a test in response to a pattern of adverse reactions to the blood thinner.
This article appears in the April 26, 2008, edition of NJ Daily.