Hong Kong Orders GSK to Recall Tainted Children's Drug

by VR Sreeraman on  June 10, 2011 at 8:30 PM Drug News
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Hong Kong has ordered the drug manufacturer, GlaxoSmithKline, to recall an antibiotic for chidren, following detection of plastic additives which exceeds the European safety limits.
 Hong Kong Orders GSK to Recall Tainted Children's Drug
Hong Kong Orders GSK to Recall Tainted Children's Drug

A government spokesman said Friday that tests revealed the Augmentin antibiotic syrup produced by the British firm's French factory contained an unsafe level of a plasticiser known as Diisodecyl phthalate (DIDP).

France's drug regulator had been notified of the syrup recall on Thursday, he added.

The drugs maker is the latest company to become embroiled in a scare over plasticisers -- chemicals used to make plastic pliable -- with Hong Kong banning several Taiwanese drinks in recent weeks after tests showed they were tainted with excessive amounts of another plasticiser.

Taiwan has issued a major recall of products, including nearly half a million bottles of sports drinks and fruit juice, over fears they contained the chemical used in plastics.

GlaxoSmithKline's popular Augmentin powder was found to contain twice Europe's limit for DIDP in food, the spokesman said, adding that long-term consumption at high levels may have adverse effects on the liver.

"(GlaxoSmithKline) 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.

The company said it would cooperate with the government to work out logistics of the recall, but challenged the decision and urged consumers not to panic.

"We do not 100 percent agree with the calculation of the safety levels of the drugs, we would like to clarify with the authorities," a spokeswoman from the firm's Hong Kong office told AFP.

"For those who are on the drugs, we don't suggest them to stop taking it immediately. They should at least finish the course or they can discuss with their healthcare professionals," she said.

She said it was not immediately clear what quantity of the drug was affected.

Hong Kong's undersecretary for food and health Gabriel Leung has said existing laws allow the authorities to revoke the licence of any medication with problems and they would seek advice on whether further legal action was needed.

Hong Kong also announced early Friday that it would ban the import of all fruit syrup produced by manufacturer Jin Zhuan Lifesciences Enterprise in Taiwan over concerns about plasticiser additives.

China, the Philippines and South Korea have also limited imports or sales of foodstuffs from Taiwan after the alarm was raised over the chemical DEHP, which can cause hormone malfunctions in children.

Source: AFP

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