Hong Kong

Pediatric drug yanked from market

By Ming Yeung (HK Edition)
Updated: 2011-06-10 08:02
Large Medium Small

Traces of plastics addictive found in antibiotic made by GSK

The government on Thursday ordered an international pharmaceutical manufacturer to recall an antibiotic prescribed for pediatric patients after traces of the plastics additive, DIDP, were found in the medicine.

The antibiotic is Augmentin powder for syrup 156mg/5ml, manufactured by GlaxoSmithKline Limited (GSK) in France.

It is the first time a plasticizer has been discovered in any medication in the city.

The recall follows a similar discovery and recall of Augmentin in Taiwan.

A spokesman for the Department of Health said the government has increased surveillance of pharmaceutical products containing flavoring agents after plastics additives were discovered in foods and beverages manufactured in Taiwan in May.

Two Augmentin products are available in Hong Kong: Augmentin powder for syrup manufactured in France, and Augmentin powder for syrup made in the UK. Both medications are commonly prescribed for children over one month old.

"On testing, the government laboratory found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific limit for DIDP for food contact materials. Plasticizers were not otherwise detected in the other samples tested," the spokesman said.

The spokesman said that even though no adverse effects have been reported from the consumption of Augmentin, the firm (GSK) had failed to demonstrate the safety of the tainted product to the satisfaction of the Department of Health.

"The threat to public health cannot be ruled out at this stage," the spokesman added.

William Chui Chun-ming, honorary associate professor from the Department of Pharmacology and Pharmacy at the University of Hong Kong Li Ka Shing Faculty of Medicine, said he was shocked to learn that a major multinational like GSK would have been so negligent as to allow contamination of its products with excess amounts of plasticizer.

He said he suspected plastic containers were the cause of the contamination and he did not rule out the possibility other big drug companies could have the same problem.

The recalled antibacterial drug was widely used for the treatment of respiratory, gastrointestinal and dental infections in Hong Kong, Chui said, adding that the supply could be substituted by the same antibiotic manufactured locally or other similar antibiotics such as macrolides.

The spokesman cautioned patients who are taking the drug to consult their doctor or pharmacist immediately and not just stop using it.

"Otherwise, there could be implications on both the courses of the diseases under treatment as well as antibiotic resistance development here," the spokesman warned.

To ease people's concerns over drug safety, Professor Chui suggested the government order all drug companies producing fruit-flavored syrup to test traces of plastics additives and to submit results to the government immediately.

"There is no way the government should use the public purse to guarantee drug safety, which is the responsibility of drug companies," Chui commented.

"Moreover, it will be faster for them (the drug companies) to test it themselves."

China Daily

(HK Edition 06/10/2011 page1)