Hong Kong yanks GSK drug on phthalate levels

A GlaxoSmithKline ($GSK) antibiotic for kids has found itself under the microscope as Hong Kong authorities ordered a recall. The region's Department of Health said lab tests found higher-than-allowable concentrations of a plasticizing agent in the drug, Augmentin powder for syrup. The Hindu reports GSK could face prosecution because of the contamination.

The offending chemical, Diisodecyl phthalate, was found at two times the European limit, Hong Kong officials said. The government there has been routinely testing products with flavoring agents after products in Taiwan were found to contain plasticizers similar to--but more toxic than--the phthalate found in GSK's product, the newspaper reports.

No adverse events have been reported about the tainted product, so the recall order is a precaution. A government spokesman told The Hindu that GSK hasn't demonstrated the phthalate levels in its product are safe. Animal tests of the pure chemical have found that long-term consumption could damage the liver. "The threat to public health cannot be ruled out at this stage," the spokesman said.

The company said that the chemical hadn't been deliberately added to the Augmentin product, which was manufactured in France. A Hong Kong expert, William Chui Chun-ming of the University of Hong Kong's medical school, told China Daily that plastic containers may have been the cause of the contamination and suggested that other drug companies might have similar problems. He also recommended that the government order all drugmakers producing flavored syrup products to test for traces of plastics additives.

- get the story from The Hindu
- see the news from Reuters
- check out the China Daily piece

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