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U.S. research on diabetes drug Avandia has little effect in China

Shanghai. May 25. INTERFAX-CHINA - A research report suggesting that a GlaxoSmithKline-manufactured diabetes drug can increase the risk of heart attack has had little effect on the use of the drug in China, a hospital official told Interfax today.

"When a drug causes severe adverse drug reactions or even death, then it will have an impact on the use of the drug in China," said Liu Shijun, chief pharmacist of the Jinan Military Zone General Hospital in Shandong, in reference to reports GSK's Avandia increases the risk of heart attack. Lui said doctors would continue to use Avandia when necessary but that they may be more careful about prescribing the drug to people with a pre-existing heart condition.

Avandia, known by its generic name as rosiglitazone maleate, has been widely used in the treatment of type 2 diabetes. U.S. researchers reported Monday that the drug can increase a user's risk of heart attack by 43 percent. The findings were published in the New England Journal of Medicine, which led to a response by U.S. Food and Drug Administration through the issue of a safety alert Monday for the drug.

Du Wenming, vice director of the Shanghai Adverse Drug Reaction Center, advised patients taking Avandia to see their doctors to ensure they were not experiencing an abnormal heart rate and to consider the risks. His opinion was expressed on one China's largest Internet portals, Sohu.com. He said patients should consult their doctor before switching the drug as abandoning it completely would cause abnormal blood sugar levels.

Pan Changyu, director of the endocrine department of Chinese PLA General Hospital in Beijing, also posted comments on Sohu, advising Avandia users not to be afraid of the drug, given there had been no reported severe adverse drug effects from its use in China.

Another doctor, surnamed Su, from Rui Jin Hospital in Shanghai said the statistics would not change the way he prescribed the drug. "We knew of the drug's complications before these results came out," he said. But Su added that a final U.S. FDA conclusion was important as a guide for doctors when prescribing drugs.

GSK has said in a statement that it strongly disagrees with the conclusions reached in the NEJM article, which it said were based on incomplete evidence and a methodology that the author admitted had significant limitations. GSK said it stood firmly behind the safety of Avandia when used appropriately, and believed "its significant benefits continue to outweigh any treatment risks".

GSK introduced the drug to China in 2000. Industry figures show that in the first half of 2006, the sales of the drug in some of China's 500 sample hospitals had risen from No. 278 to No. 153 over the last year in drug sale rankings, producing sales of more than RMB 40 million ($5.23 million) last year.

The Chinese SFDA announced yesterday it was analyzing the drug and would consider any rulings by the U.S. FDA and the European Agency for the Evaluation of Medicinal Products. It will give its own appraisal on the drug once the analysis is complete.

-KZ
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