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US regulators finish Chinese inspection, still do not know what caused blood-thinner problems

US regulators finish Chinese inspection, still do not know what caused blood-thinner problems

U.S. inspectors found some mostly procedural problems at a Chinese factory that supplied the main ingredient for the recalled blood thinner heparin but say they cannot yet tell what is causing serious side effects.
"We're still considering all possibilities," said Deborah Autor, compliance chief at the U.S. Food and Drug Administration. "We have not ruled anything out at this point."
Baxter International halted production this month after the blood thinner was linked to four deaths and hundreds of reports of allergic-type reactions, including vomiting, nausea and difficulty breathing.
The FDA has completed an inspection of the Chinese factory, Changzhou SPL, that supplied the active ingredient, and took the unusual step Thursday of posting its draft inspection findings on the agency's Web site. The FDA is under intense scrutiny in the probe after it acknowledged that an agency mix-up meant the Chinese factory had never been inspected before its heparin began selling.
Inspectors compiled a list of possible problems in how workers ensure they are producing quality drugs.
Among the findings:
_A lack of specific procedures outlining removal of impurities.
_Workers reprocessed the drug that did not meet specifications without determining what caused the initial problem.
_No records showed suppliers' sources of the products.
_Some apparently improperly cleaned and maintained equipment.
Heparin, used to prevent blood clotting, generally is made from pig intestines. In China and other developing countries, tracing the source of animals used to make it can be difficult.
The FDA stressed that inspectors' initial findings are preliminary and must be investigated further. China is not the probe's only focus; the FDA also is conducting inspections at facilities in the United States.
The FDA said Thursday that it now has 448 reports of possible problems in patients taking heparin from any manufacturer, but the agency thinks that those associated with the problematic Baxter product number 215.
Baxter had not formally recalled all the problematic heparin vials because the FDA feared doing so would trigger a shortage. Thursday, Baxter took that next step, after the FDA verified that a second U.S. supplier has ramped up to fill the gap.
Of most concern are vials of heparin used in fairly large doses, such as for heart surgery or during dialysis. But also recalled Thursday, in what FDA said was a purely precautionary move, was Hep-Lock, a very diluted product used to prevent blood clots from forming in intravenous medication lines. It was recalled because it was made with the same ingredient as heparin.
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On the Net:
http://www.fda.gov/cder/drug/infopage/heparin/default.htm


Updated : 2021-06-21 15:52 GMT+08:00