Regulators suspend Avandia over safety concerns
Rosiglitazone-containing medicines will cease to be available in Europe
Friday, 24 September 2010
The cardiovascular risks of rosiglitazone (Avandia, Avandamet) are no longer outweighed by its benefits, regulators announced late yesterday. The UK’s Commission on Human Medicines (CHM) reviewed all available data and concluded that there is an increased cardiovascular risk for rosiglitazone. It could identify no additional measures that would reduce the cardiovascular risk, nor could it identify a single patient population in whom the benefits continue to outweigh the risks.
The Committee on Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has recommended that marketing authorisations for rosiglitazone products should be suspended across the European Union.
When Avandia was first licensed in 2000 it was restricted to a second-line treatment, and contraindicated in patients with heart failure or a history of heart failure. Over the past three years, as data suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone, further restrictions were placed on its use in patients with ischaemic heart disease.
Recent studies showed an increased risk of cardiovascular disorders, such as heart attacks, strokes and heart failure, among people taking rosiglitazone. These new data triggered initiation of a Europe-wide review on 9 July. Its conclusions concurred with the UK Medicines and Healthcare products Regulatory Agency (MHRA) that the scientific evidence shows that rosiglitazone is associated with an increased risk of cardiovascular disorders.
Rosiglitazone will cease to be available in Europe within the next few months, allowing doctors to conduct a ‘timely review’ with their patients to discuss alternative treatments.
The CHM’s advice to healthcare professionals and patients is that:
- Prescribers should put in place a system to ensure that all patients are reviewed and changed to another suitable treatment in line with NICE recommendations.
- Although this change could happen at the next routine appointment, prescribers might wish to see patients sooner rather than later in order to allay patient anxiety.
- Patients who are concerned should not stop their treatment but should contact the healthcare professional supervising their diabetic treatment.
MHRA chief executive Professor Kent Woods said: “Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone. Today’s suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment.”
Simon O’Neill of Diabetes UK said: “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.”