FDA Decides to Significantly Restrict Avandia But Remain on Market
Margaret A. Hamburg MD, Commissioner of the US Food and Drug Administration (FDA), announced today that the agency will follow its advisory panel’s recommendation to keep GlaxoSmithKline’s diabetic drug Avandia for sale on the US market, but with significant use restrictions. GSK will be required to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD to provide additional clarity about the findings.
Patients Will Be Carefully Screened Prior to Avandia Prescription
In July, an FDA advisory panel voted 21-3 that clinical trial data does suggest that patients on Avandia, generically known as rosiglitazone, have an elevated risk of cardiovascular events such as heart attack and stroke, but that the risk of death was not greater than that of other diabetes treatments.
The FDA ruling today will restrict the use of Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications. Doctors will have to attest to and document their patients’ eligibility and patients will have to review and acknowledge statements describing the cardiovascular safety concerns associated with the drugs.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said Dr. Hamburg. “We are seeking to strike the right balance to support clinical care.”
Avandia is a drug intended to improve glucose control in patients with Type 2 Diabetes Mellitus. It belongs to a class of medications known as thiazolidinediones, or TZDs. Actos (pioglitazone) is a similar medication in this class of drugs.
The European Medicines Agency (EMA) has suspended the sale of Avandia entirely in Europe due to safety concerns. This will include all forms of the medication, including Avandamet and Avaglim, drugs that combine rosiglitazone with other diabetes medications. Patients will be transitioned to alternative treatment options.