Recall of GlaxoSmithKline's French-made Augmentin powder for syrup 156mg/5ml

2011-06-09  Hong Kong (HKSAR) - The Department of Health (DH) today (June 9) ordered GlaxoSmithKline Limited (GSK) to recall from its consumers an antibiotic manufactured in France for paediatric patients, Augmentin powder for syrup 156mg/5ml (HK-24658), as the detection of a plasticiser, Diisodecyl phthalate (DIDP) has raised both safety and quality concerns. A spokesman for DH said, "In view of the latest development in Taiwan's plasticiser incident, the DH has enhanced its surveillance on pharmaceutical products containing flavouring agents." Referring to the detection of plasticiser in Augmentin in Taiwan in particular, the spokesman explained, "Augmentin is an antibiotic for the treatment of bacterial infections. In Hong Kong, there are two Augmentin products containing flavouring agents, both of which are registered under GSK by the Pharmacy and Poisons Board, namely Augmentin powder for syrup 156mg/5ml manufactured in France, and Augmentin powder for syrup 457mg/5ml manufactured in the UK. Both are for use in children. Samples were submitted earlier on to the Government Laboratory (GL) for plasticiser analysis." The spokesman went on to reveal that, "On testing, the GL found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific migration limit for DIDP for food contact materials. Plasticisers were not otherwise detected in the other samples tested." "DIDP's safety in man is not well established. However, data on animal studies suggested that long-term consumption of DIDP at high level may affect the liver. It is a fact that the DH has not received any report of adverse events related to the product, but GSK has failed to demonstrate the safety of the tainted product to our satisfaction. The threat to public health cannot be ruled out as this stage," the spokesman added. "Moreover, there could also be the issue of the selling of a drug not of the nature, substance or quality demanded by the purchaser here, meaning that the Public Health and Municipal Services Ordinance (Cap. 132) might have been contravened. The maximum penalty involved here is a fine of $10,000 and three months' imprisonment. In any case, DH will refer the whole matter for the Department of Justice's legal advice after having completed our investigation," the spokesman continued. The spokesman cautioned patients who are currently using the above drug for treatment to consult their attending doctors or pharmacists as soon as possible and to not just stop using the drug abruptly. "Otherwise, there could be implications on both the courses of the diseases under treatment as well as antibiotic resistance development here," the spokesman warned. In connection, anyone who has taken the drug and is either in doubt or feeling unwell also ought to seek professional advice from healthcare providers. "Meanwhile, DH will continue to monitor the Taiwan incident, investigate the present incident and keep track of the present recall besides maintaining enhanced vigilance on pharmaceutical products with flavouring agents," the spokesman stated. Source: HKSAR Government