The State Food and Drug Administration (SFDA) said Tuesday to monitor several medications produced by Swiss pharmaceutical Roche for possible adverse reactions.
The SFDA issued a statement after a European Medicines Agency investigation revealed that Roche failed to report adverse reactions to some of its drugs. About 15,000 patient deaths have been possibly tied to such reactions.
The SFDA has asked the company to report details of the reactions and will closely follow development of the case, the statement said.
Five of the eight medications, for treating cancers and a liver disease, involved in the investigation are sold in China, the SFDA said.
The SFDA monitoring network has not yet reported abnormal cases related to the medications, the statement said.
In a statement on Roche China's website, the firm said the adverse reactions that resulted in deaths all occurred in the United States, claiming that there has been no impact on safety of its products based on current assessments.
The company said it would cooperate with the Chinese government in related inquiries and possible investigations.
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