The article, published in the New England Journal of Medicine, raised concerns about the safety of rosiglitazone (Diabetes drug may increase MI risk). However, the EMEA has stated that they were aware of many of the studies and they had been assessed by the agency's safety committee. As a result, the EU product information was updated in September 2006 with information about the risk of cardiac ischaemic events.
The EMEA point out that some of the studies discussed in the NEJM paper included patient who were not treated in line with the indication approved in the EU. The agency emphasise that prescribers should adhere to the restrictions for use in patients with cardiac disease as set out in the product information.
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