Hong Kong orders recall of Glaxo children's drug

10th June 2011, Comments 0 comments

Hong Kong has ordered pharmaceutical giant GlaxoSmithKline to recall an antibiotic used to treat infections in children which contained a chemical additive twice recommended European safety limits.

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.

But the firm appeared to contradict Hong Kong's findings, saying the "level of DIDP exposure identified as present in the sample tested is significantly lower than the levels that the US and European authorities deem to present a level of risk."

The firm added that is does not "intentionally" use the additive in its products, but said phthalates "are ubiquitous and are present as trace compounds in the environment and in many common items of daily consumption."

Hong Kong's undersecretary for food and health Gabriel Leung told reporters Friday: "Existing laws provide us with the option of revoking the licence of any medication with problems."

"We will seek advice from the Department of Justice to see if further legal action shall be taken," he added.

The Hong Kong health department did not say how much of the syrup was available in the teeming city of seven million.

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.

© 2011 AFP

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