(Reuters) - U.S. health regulators issued recommendations to manufacturers to ensure the safe production of the blood-clot prevention drug heparin, four years after a contamination involving the widely used product set off concerns about the global pharmaceutical supply chain.
The draft guidance, posted on the website of the Food and Drug Administration, is designed to help manufacturers of active ingredients, finished products and others better control heparin to avoid contamination.
The FDA began receiving reports in early 2008 of serious reactions, including some deaths, among some patients undergoing dialysis and traced the problem to heparin, which is injected.
An FDA probe found a contaminant in batches of heparin from Baxter International Inc, a major supplier to the U.S. market, and determined the contaminant was in active ingredients for heparin made in China.
The contamination sparked congressional hearings and concerns about the lack of inspections of foreign facilities.
According to the guidance document, contamination involving the chemical at issue -- oversulfated chondroitin sulfate (OSCS) -- appears intentional to save costs.
"OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration -- i.e., heparin appeared to be intentionally contaminated with OSCS to reduce the cost of production," the agency said in its document.
Heparin is derived from pig intestines, and the FDA also said that "substitution of non-porcine sources of crude heparin raises concerns" -- in particular materials from cows because of the potential for contamination with material infected with mad-cow disease.
"Both the reported incidents of OSCS contamination and the bovine substitution scenario illustrate the potential for FDA-regulated products derived from heparin to be contaminated," the agency said.
The agency's recommendations included testing for the species origin and the presence of OSCS in each shipment of crude heparin before manufacturing. Heparin manufacturers should also audit their suppliers, the agency said.
The guidance is a set of recommendations and does not establish legally enforceable responsibilities. FDA will solicit comments on the document for 60 days.
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