European Medicines Agency decides to suspend Avandia
23 September 2010
The European Medicines Agency (EMA) has announced a recommendation to suspend all forms of Avandia (rosiglitazone) from the European market this afternoon following a review into the safety of the drug.
Diabetes UK is advising anyone currently taking Avandia to consult their healthcare team without delay to discuss switching onto an alternative treatment that is best suited to their needs.
Why has it been withdrawn?
Research has suggested that people with diabetes who take Avandia have an increased risk of cardiovascular disease.
A panel of experts at the EMA then met this week to review the risks and benefits of Avandia and announced this afternoon that they no longer deemed it to be a safe and effective drug for people with diabetes. At the same time as the EMA announcement, regulators in the US have confirmed tougher restrictions over the drug's use.
Diabetes UK advice
"The EMA (European Medicines Agency) no longer believe that Avandia (rosiglitazone) is a safe treatment. We are therefore recommending that people with diabetes currently taking Avandia get in touch with their healthcare team as a matter of urgency to discuss their treatment options," said Simon O’Neill, Director of Care, Information and Advocacy at Diabetes UK.
"We would not advise them to stop taking their medication in the meantime unless they are experiencing adverse side effects (such as swollen ankles or breathlessness) as it is very important that people with diabetes keep their blood glucose under control to prevent short and long term complications.
"People with diabetes should be given information about the risks and benefits of all the alternative treatment options available to them so that they can reach an informed decision about their best option with their healthcare team.
Patient safety is paramount
"Patient safety is paramount, so we welcome that a decision has been made about Avandia so people can now be supported to change onto an alternative treatment. We would urge the EMA to make swifter decisions in the future to ensure patient safety."