2011/06/09The Central News Agency Local newspapers reported Thursday that major hospitals around Taiwan have suspended the use of the GlaxoSmithKline Plc (GSK) -produced antibiotic Augmentin over plasticizer contamination concerns. According to media reports, mild levels of the banned chemical di-isodecyl phthalate (DIDP) were detected in the Department of Health (DOH) tests on GSK's Augmentin, commonly used to treat bacterial infections, particularly in children. Since a local TV news channel reported Tuesday that Augmentin bought at local pharmacies contained DIDP -- a substance often used in the production of plastics to make it more flexible -- quite a few parents have asked doctors not to prescribe the drug for safety concerns. TVBS said Tuesday laboratory tests show that the Augmentin purchased at local pharmacies contained 14.8ppm (parts per million) of DIDP, while a strawberry-flavored Augmentin syrup often prescribed for children at local clinics was found to contain 18.1 ppm of DIDP. In response, the Taiwan branch of GSK said that all the company's products on the Taiwan market met the standards of Good Manufacturing Practices and had been certified by Taiwan's health authority before entering the market. DOH tests show GSK's Augmentin contains 9-13.7 ppm of DIDP, levels that officials said pose no health risks to humans. The following are excerpts from the local media coverage of the issue: China Times: GSK, a leading global pharmaceutical, biologic, vaccine and consumer healthcare company headquartered in London, said it has no plans to pull Augmentin from pharmacy shelves at the moment. Hospital administrators and medical practitioners said the government should push the healthcare company to explain why the banned chemical was detected in its product. They also asked health authorities to conduct an across-the-board examination of all pediatric drugs to alleviate public panic over plasticizer contamination that has gripped the country since mid-May, when another toxic, phthalate-based plasticizer, DEHP, was detected in a variety of food and beverage products. Kang Jaw-jou, director-general of the Taiwan Food and Drug Administration (TFDA) under the DOH, said Wednesday that although the levels of DIDP detected in Augmentin were limited and could be translated to about 2 micrograms (mcg) in each dose -- an amount unlikely to harm human health, his agency will still ask GSK to produce proof showing it has not wittingly or maliciously adulterated its antibiotic with the banned substance. GSK argued that powdered ingredients used in Augmentin syrup were made in the United Kingdom and that the DIDP levels detected are far lower than the levels seen as harmful or dangerous in the United States or the European Union. Insisting that Augmentin remains a safe prescription medicine, GSK said it is investigating how and why DIDP made its way into the product in the first place. "We are waiting for the examination results from an independent and impartial third party," it added in a statement. Meanwhile, Kang said that as some phthalate-based plasticizers can help maintain density and functions of a specific drug in humans, major advanced countries such as the United States have not barred their use in some pharmaceuticals.Of the more than 20,000 drug certificates issued by the DOH, more than 80 have been issued to pharmaceuticals containing two other phthalate-based plasticizers -- DBP or DEP -- Kang said. (June 9, 2011) United Daily News: Kang said Wednesday that the DOH will not order GSK to recall Augmentin for the time being and that hospitals can decide on their own whether to suspend their use of the antibiotic. All major local hospitals, including National Taiwan University Hospital, Veterans General Hospital, Mackay Memorial Hospital, Shin Kong Wu Ho Su Memorial Hospital, Cathay General Hospital and Tri-Service General Hospital have suspended the prescription of Augmentin.
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