Concern grows over plasticizers used in medicines

08:58, June 17, 2011      

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While China's health authorities are busy protecting its people from food contaminated by harmful plasticizers such as DEHP, the risk appears to be spreading into the pharmaceutical industry.

The State Food and Drug Administration (SFDA) confirmed with China Daily on Wednesday that three kinds of plasticizers, DMP, DEP and DBP, are legally recognized in China's 2010 Pharmacopoeia as inert in drug production and therefore safe.

The plastic additives, although totally banned in food, can help with duration, color and texture of drugs and do not harm consumers' health as long as their concentration in drugs is within safety limits, said Liu Dong from the administration's information office.

However, Wang Yuedan, who has a PhD in immunization from Peking University, disagreed.

"Currently there are no specific regulations on the use of plasticizers in medicines, such as the maximum content," he said. "The chemicals, which could cause reproductive problems, particularly for boys, are quite likely to be abused in the pharmaceutical industry in this country."

Used in sustained-release drugs and drugs that come in powder form and in film-coated tablets, the recognized plasticizers are contained in more than 300 kinds of medicines, industry insiders said.

Although people take medicines only occasionally and usually in small amounts, the authorities should not ignore the risks as the chemicals are scientifically proven to be harmful to human health, Wang said. He called for a change to the pharmacopoeia.

However, Zhou Fucheng, deputy secretary-general of the Chinese Pharmacopoeia Commission, said such a change would not be easy and needed further safety investigation and assessment.

"The use of plastic additives in drug manufacturing dates back many years in many countries, including China," he told China Daily on Wednesday.

"There is no need to panic about their use in drugs at all," he said.

The situation is different with food, which is consumed every day. Intakes of the additives from drugs are too small to affect human health, said Sun Zhongshi, a Beijing-based drug safety expert.

Also, the limits for the use of the additives are in accordance with international standards, he noted.

"The key is that the permitted dosage of such materials should be added to regulations and relevant government agencies should increase their supervision," he said.

However, earlier this month the health department of Hong Kong ordered the recall of a Taiwan-made pharmaceutical product suspected of DEHP contamination.

"In Hong Kong, DEHP, a plastic additive, is not used as an active ingredient. Its presence in drugs should not be allowed," a spokesman for the department said.

In Taiwan, public concern over the safety of the strawberry-flavored antibiotic Augmentin Syrup, which is produced by leading healthcare company GlaxoSmithKline, was widespread around June 9 after it was found to contain 14.8-18.1 parts per million of banned plasticizer DIDP.

Several local hospitals suspended the use of the medicine, although the local health department said the amount of the plasticizer in drugs was within safety limits.

GSK Taiwan pointed out that trace amounts of such plasticizers exist in many daily products, probably due to packaging, but stressed that it had never used such material in production.

On the mainland, SFDA banned two food products containing plasticizers on June 3 and is now closely monitoring the use of plasticizers by checking and sampling relevant goods, Xinhua reported.

Source: China Daily
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