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Friday 21st October 2016

US says Chinese heparin 'safe'

12th May 2008

A Chinese-made blood thinning drug which has been linked to dozens of deaths in the United States is now safe following the imposition of tighter testing and controls, a US health official said.


US Health and Human Services secretary Mike Leavitt said officials had now put in place processes which would ensure the safety of the drug, which has caused 81 deaths and hundreds of allergic reactions because of a contaminant in certain batches from China.

The Food and Drug Administration was planning to station inspectors in China and other countries manufacturing products for the US market, in a bid to ensure that all exporters of food, drugs and other products met more stringent quality and safety checks, Leavitt said.

He said the US was rolling out a substantial change in strategy in the wake of a series of quality control scandals, especially in products coming from China. The FDA offices in China will help improve product safety.

The 81 reported deaths linked to tainted heparin are believed to be linked to raw materials used in Chinese manufacturing plants for the drug, which is widely used in dialysis and other common medical procedures.

The FDA identified the contaminated ingredient as oversulfated chondroitin sulfate, saying it may have been put into the drug as a "filler" to make it go further. The problems were mostly found in shipments of Heparin USP, which is given in large doses intravenously during heart surgery and kidney dialysis to prevent clotting.

FDA inspectors inspected the Changzhou SPL plant that made the main heparin ingredient for Baxter International in February. Baxter has said it is seeking further access to investigate the drug's production lines.

China's drug safety agency has asked the FDA to provide details of victims and specifics about production, but it has refused, limiting the scope of its heparin investigation.

Beijing says the FDA is getting in its own way, and challenges the assumption that the deaths in the US were linked to the contaminant.

Meanwhile, the FDA withheld a list of Chinese heparin suppliers requested by congressional investigators, saying confidentiality agreements prevent release of the companies' names.

The agency says it will rely on voluntary testing agreements with some companies to check their heparin ingredients for contamination before they distribute their supplies in the US, saying it lacked the legal authority to impose outright import controls.




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