Local newspapers reported Thursday that major hospitals aroundTaiwan have suspended the use of the GlaxoSmithKline Plc(GSK) -produced antibiotic Augmentin over plasticizer contaminationconcerns.
According to media reports, mild levels of the banned chemicaldi-isodecyl phthalate (DIDP) were detected in the Department ofHealth (DOH) tests on GSK's Augmentin, commonly used to treatbacterial infections, particularly in children.
Since a local TV news channel reported Tuesday that Augmentinbought at local pharmacies contained DIDP -- a substance often usedin the production of plastics to make it more flexible -- quite a fewparents have asked doctors not to prescribe the drug for safetyconcerns.
TVBS said Tuesday laboratory tests show that theAugmentin purchased at local pharmacies contained 14.8ppm (parts permillion) of DIDP, while a strawberry-flavored Augmentin syrup oftenprescribed for children at local clinics was found to contain 18.1ppm of DIDP.
In response, the Taiwan branch of GSK said that all the company'sproducts on the Taiwan market met the standards of Good ManufacturingPractices and had been certified by Taiwan's health authority beforeentering 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 theissue:
GSK, a leading global pharmaceutical, biologic, vaccine andconsumer healthcare company headquartered in London, said it has noplans to pull Augmentin from pharmacy shelves at the moment.
Hospital administrators and medical practitioners said thegovernment should push the healthcare company to explain why thebanned chemical was detected in its product.
They also asked health authorities to conduct an across-the-boardexamination of all pediatric drugs to alleviate public panic overplasticizer contamination that has gripped the country since mid-May,when another toxic, phthalate-based plasticizer, DEHP, was detectedin a variety of food and beverage products.
Kang Jaw-jou, director-general of the Taiwan Food and DrugAdministration (TFDA) under the DOH, said Wednesday that although thelevels of DIDP detected in Augmentin were limited and could betranslated to about 2 micrograms (mcg) in each dose -- an amountunlikely to harm human health, his agency will still ask GSK toproduce proof showing it has not wittingly or maliciously adulteratedits antibiotic with the banned substance.
GSK argued that powdered ingredients used in Augmentin syrup weremade in the United Kingdom and that the DIDP levels detected are farlower than the levels seen as harmful or dangerous in the UnitedStates 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 theproduct in the first place. "We are waiting for the examinationresults from an independent and impartial third party," it added in astatement.
Meanwhile, Kang said that as some phthalate-based plasticizerscan help maintain density and functions of a specific drug in humans,major advanced countries such as the United States have not barredtheir use in some pharmaceuticals.
Of the more than 20,000 drug certificates issued by the DOH, morethan 80 have been issued to pharmaceuticals containing two otherphthalate-based plasticizers -- DBP or DEP -- Kang said. (June 9,2011)
United Daily News:
Kang said Wednesday that the DOH will not order GSK to recallAugmentin for the time being and that hospitals can decide on theirown whether to suspend their use of the antibiotic.
All major local hospitals, including National Taiwan UniversityHospital, Veterans General Hospital, Mackay Memorial Hospital, ShinKong Wu Ho Su Memorial Hospital, Cathay General Hospital andTri-Service General Hospital have suspended the prescription ofAugmentin. (June 9, 2011).
(By Sofia Wu)