Taipei Times 2011/06/11 The amount of the substance di-isodecyl phthalate (DIDP) found in the antibiotic Augmentin manufactured by leading global pharmaceutical company GlaxoSmithKline PLC (GSK) is within safe limits, Department of Health (DOH) officials said on Thursday.The amount of DIDP found in each dose of the drug is below 2mcg, which is far lower than the 9mg allowable daily limit under EU regulations, Food and Drug Administration Director-General Kang Jaw-jou (康照洲) said. Kang said the chemical content in the drug was not harmful and that the department has not asked GSK to remove the drug from store shelves. Augmentin is primarily used to treat bacterial infections, such as ear infections, pneumonia, bronchitis and urinary tract infections. Kang's remarks came after department tests on samples of the drug showed that it contained between 9 parts per million (ppm) and 13.7ppm of DIDP. Supplements, sport drinks and juices have recently been discovered to contain plasticizers, used as a substitute for more expensive ingredients in clouding agents, a common food additive. In response to the department's call for clarification, GSK's Taiwan branch issued a statement saying that it was conducting further investigations to determine the source of the plasticizer. However, several major hospitals in the country have already suspended use of the strawberry version of the drug out of safety considerations until the matter is settled by the department. Meanwhile, in related developments, Department of Health Minister Chiu Wen-ta (邱文達) said the government has not yet found any clinical evidence of suspected health problems resulting from consumption of foodstuffs containing di(2-ethylhexyl) phthalate, or DEHP, or other kinds of plasticizers. Amid the food scare, a total of 124 medical institutes have advised people on health risks caused by consumption of plasticizer-tainted products and performed examinations since May 27. Chiu cited reports that quoted Gregory Hartl, a spokesman for the WHO's Global Alert and Response, as saying that DEHP is not immediately life-threatening. The International Agency for Research on Cancer, an institution under the WHO that coordinates and conducts research on the causes of cancer, has concluded that there is "inadequate evidence" in humans for the carcinogenicity of DEHP, Chiu said. Some experts have suggested exposure to DEHP causes a decrease in sperm production, Chiu said, adding the department would continue to investigate health risks associated with plasticizer exposure.
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