The Medicines and Healthcare products Regulatory Agency have announced the outcome of a Europe wide safety review of the glitazones.
The review found a positive benefit-risk balance for both pioglitazone and rosiglitazone. However, prescribing information should be updated for the latter drug to indicate that it should only be used in patients with ischaemic heart disease only after a careful evaluation of the patient's individual risk and that it should only be used in combination with insulin in exceptional cases and under close supervision.
Action: Clinicians should be aware of the outcome of this review and the new cautions added to the prescribing information for rosiglitazone. Metformin and sulphonylureas remain the oral hypoglycaemics of choice, pioglitazone may be an alternative to these drugs in case of intolerance or where contraindications exist.
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