The antidiabetic drug rosiglitazone is in big trouble as the decisions from major regulatory bodies were announced today.
The European Medicines Agency (EMA) announced today that it is recommending the suspension of the marketing license of antidiabetic drugs that contain rosiglitazone. This includes the drugs marketed in Europe as Avandia, Avandamet, and Avaglin.
The EMA suspension will take effect within the next few months and “will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.”
In the US, the Food and Drug Administration (US FDA) decided that Avandia stays on the US market but under strong restrictions. According to an FDA statement today:
The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Rosiglitazone has been under scrutiny due to the side effects of fluid retention and increased risk of heart failure which came out during postmarketing studies. Avandia is a product of the UK drug marker GlaxoSmithKline (GSK).
What should patients in Europe who are taking rosiglitazone do?
The European Association for the Study of Diabetes (EASD) issued the following press statement earlier today:
Patients should be aware that stopping a diabetes medication without consulting a doctor can result in higher levels of blood glucose that may cause serious short term health problems and increase the risk of long-term diabetes-related complications.
Optimal control of glucose, cholesterol and blood pressure is needed in order to limit the risk of long-term complications, and several alternative types of treatment are available to help those with type 2 diabetes achieve these objectives.
In any case, this may be the end of rosiglitazone. Even if its stays in the US market, its cardiovascular safety is seriously suspect that no clinician will ever consider prescribing the drug to patients.