Regulator launches safety review of diabetes drug
By Nigel Praities
The European medicines regulator has announced a major review of rosiglitazone, after recent data raised renewed questions about its cardiovascular safety.
A statement from the EMEA said the Committee for Medicinal Products for Human Use (CHMP) would review the new data for rosiglitazone and decide if it should keep its current licence.
Over 564,000 prescriptions for Avandia were dispensed in 2009 in UK primary care, but recent data has shown a consistent excess cardiovascular risk with rosiglitazone.
A meta-analysis of 56 trials published in the Archives of Internal Medicine showed a 28-39% excess risk of myocardial infarction with the drug for diabetes.
The Food and Drugs Administration in the US is also meeting this week to review the safety of rosiglitazone.
The EMEA statement said: ‘Once all relevant data on the benefits and the risks of rosiglitazone have been looked at, the CHMP will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed.'
However Dr Tony Hoos, European medical director for GSK, defended the treatment.
‘GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients,' he said.
‘It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.'Regulator launches safety review of diabetes drug