The benefits of using rosiglitazone were found to outweigh the risks, according to the EMEA.
However, it recommends that the prescribing information should be updated to include a warning that, in patients with ischaemic heart disease, rosiglitazone should only be used after careful evaluation of risk.
Additionally, the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision.
The changes will be introduced in forthcoming regulatory procedures for rosiglitazone-containing medicines. But no changes will be made to the prescribing information for medicines containing pioglitazone.
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