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China orders recall of drug over toxic fears

Shanghai's pediatric hospitals yesterday started to remove a GlaxoSmithKline antibiotic treating children's upper respiratory diseases and urinary tract infection from their pharmacies and inform parents that they will give full reimbursement if returning the drug. The emergency actions were launched after the State Food and Drug Administration issued a statement on its website yesterday, requiring an immediate halt of sales and use of GSK's amoxicillin and clavulanate potassium, and that products already on the Chinese market will be recalled. According to the statement, test results show that GSK's amoxicillin and clavulanate potassium product contains traces of Di-isodecyl phthalate (DIDP), a cancer-causing plastic polymer. It's the first time the plastic polymer was found in medicine after the country's food industry has been plagued by the presence of the toxic chemical since Taiwan reported the first case in May. Wang Yan from Shanghai Food and Drug Administration said yesterday that the bureau received the State FDA's notice on Friday night and reported the issue to the city's health authorities immediately. An official at Shanghai Children's Medical Center said yesterday they took action immediately by informing doctors to stop prescribing the drug and removing all stocks from the shelves. Zhang Jian, director of Xinhua Hospital's pharmacy department, another local major pediatric hospital, said the drug is a common antibiotic used for children and has been adopted in clinical use for a long time with good effects. "Removal of the GSK product won't impact our treatment, as there are many other antibiotics with similar effects and domestically made drugs with the same chemical ingredients," he said. "We have never received reports of adverse reaction in patients using the drug before." According to an email statement sent to Shanghai Daily yesterday, GSK said that it can confirm it had not deliberately used DIDP or other phthalates in the antibiotic product. The British drug company said through t! esting i t can confirm that the active ingredients, excipients and flavors, and therefore the final bulk drug substance, are free of DIDP. The only source of DIDP currently identifiable is the plastic lining inside the bottle cap and further investigations are underway. On June 9, Hong Kong Special Administrative region's Department of Health ordered the recall of GSK's Augmentin syrup and two days later, the food and drug watchdog in Taiwan recalled two of GSK's pediatric medications that were also found to contain DIDP.

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