On 23 September 2010, the European Medicines Agency (EMA) recommended the suspension of the rosiglitazone-containing anti-diabetes medicines Avandia® and Avandamet® following the review of studies questioning the cardiovascular safety of the medicine.
Professor Tony Barnett, professor of medicine/clinical director at Birmingham Heartlands Hospital, will briefly summarise alternative treatment options currently available, including DPP-4 inhibitors, in the video below. Professor Barnett will also discuss treatment considerations that affect patient choice and adherence, such as hypoglycaemia and weight gain.
Data from clinical trials, observational studies and meta-analyses of existing studies which have become available over the last three years have suggested a possible increased risk of ischaemic heart disease associated with the use of rosiglitazone.
The EMA initiated a review of rosiglitazone in July 2010, which concluded that the benefits of rosiglitazone no longer outweigh its risks, due to increased cardiovascular risk.
The EMA have also issued the following advice:
• Patients should make an appointment with their doctor to discuss suitable alternative treatments before stopping treatment
• Prescribers should stop prescribing rosiglitazone-containing medicines and, when switching, to select the most appropriate alternative based on the individual patient’s needs.
The EMA have made no specific recommendations on which product(s) to switch rosiglitazone patients to.
Date of preparation: December 2010 WCV10-048a
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Video: Professor Tony Barnett
Watch this short video to hear what Professor Barnett has to say about the rationale of the suspension and how it is likely to affect healthcare professionals in primary care.The EMA recommended the suspension of the rosiglitazone-containing anti-diabetes medicines Avandia® and Avandamet® The EMA recommended the suspension of the rosiglitazone-containing anti-diabetes medicines Avandia® and Avandamet® Novartis – Gladstone Prescribing information