SFDA attention to security of Avandia (rosiglitazone)

   Date:2007/05/28     Source:
On May 21th an article in the New England Journal of Medicine (NEJM) said there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia(R) (rosiglitazone maleate). US FDA said Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Soon Chinese medium reported the news, and the news aroused people's great concern. According to the reports, many patients wanted to know if the drug is safe and contact the doctors about it. The Chinese joint venture branch of GlaxoSmithKline assured the drug is safe and woudn't stop saling Avandia in China.

On May 24th State Food and Drug Administration (SFDA) issued a artical about Avandia in SFDA's website. SFDA said they had known about the affair, and should keep paying close attention to this drug's security data of clinical use in China and the investigation results from US FDA and EMEA, and should make the comprehensive remarks in time.

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