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Blood thinner problem goes worldwide A contaminated blood thinner from China
suspected in dozens of US deaths has become a worldwide public health
problem, with 10 other countries detecting the often-toxic ingredient.
The compound, which in tests mimics the real blood thinner heparin but
costs less to make, might have been added deliberately somewhere along a
production chain that began on farms in China, beyond the reach of US
regulators.
Food and Drug Administration officials issued a warning letter on
Monday that, until the safety issues are resolved, banned future US
shipments from the plant in China that supplied the widely used blood
thinner. And officials raised the possible death toll from 62 to 81.
At the same time, the FDA announced a scientific breakthrough in its
bid to understand how patients became sick from the contaminated heparin.
The developments came on the eve of a congressional hearing expected to
show that the FDA lacks the resources to carry out adequate inspection of
thousands of foreign facilities now producing a significant share of
medications consumed in the United States. "Contamination of the
heparin supply is a worldwide problem," said Janet Woodcock, director
of the FDA's Center for Drug Evaluation and Research. Thus far, about a
dozen Chinese facilities have been identified as being part of the supply
chain that handled contaminated heparin.
The widely used blood thinner is given to patients undergoing kidney
dialysis or heart surgery to prevent dangerous clots. The
Woodcock said the contaminant may trigger chemicals in blood cells that produce serious allergic-type reactions. These chemicals, called blood mediators, are often spurred into action when a wound is opened, helping to generate new blood vessels around the wound and drawing in antibodies to clean up damaged areas, said Marilyn Halonen, a pharmacology professor at the University of Arizona. But mediators also can cause a drop in blood pressure and other reactions in patients who receive large doses of contaminated heparin. "If this compound is getting to a lot of cells at once, it's causing a mediator storm," Halonen said. Woodcock said dangerous reactions seen in US patients and some in Germany may be linked to intravenous doses of contaminated heparin. Chinese officials have remained skeptical of such a link. At a Chinese embassy news conference on Monday, senior public health officials said they doubted the evidence linking the contaminant to serious side effects. Instead, they urged a look at the US facilities of Baxter Healthcare, the Illinois-based company that imported heparin from China and distributed it. The FDA and Baxter have maintained that the source of the problem lies in China. Heparin is produced from a naturally occurring substance found in the lining of pigs' intestines, and the process involves several layers of middlemen and suppliers. The contaminant could have been added to make the drug seem more potent, or it could have been introduced accidentally by some misstep in the production process. On Monday, the FDA cited Baxter's supplier in China for "significant deviations" from US manufacturing practices. That supplier, Changzhou SPL, is a joint venture company partly owned by Wisconsin-based Scientific Protein Laboratories. In its warning letter, the FDA said it found problems with the process used by the Chinese plant to remove impurities from heparin and also with the company's system for evaluating its suppliers. SPL responded by saying many of the concerns the FDA cited have been corrected. But the agency says it will require more proof before the Changzhou plant is allowed to export to the United States again. In a report due to be released yesterday at a House hearing, investigators from the congressional Government Accountability Office found the agency's budget for foreign inspections is not up to the task. While the FDA has about US$11 million (HK$85.8 million) for foreign inspections this year, the agency would need about US$70 million a year to inspect foreign pharmaceutical plants every two years as are US establishments. It would need US$16 million a year to inspect the estimated 714 drug manufacturing facilities in China alone. 2008-04-26 |
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