Avandia’s Dangers Realized — Its Continued Availability in Question
The Food and Drug Administration and European drug regulators made a major announcement today that will affect more than half a million Type 2 diabetics currently using Avandia, or its generic form rosiglitazone, to control their blood sugar.
Although manufacturer, GlaxoSmithKline, has continued to stand behind the drug, Avandia has been under scrutiny for years. A New England Journal of Medicine study released in May 2007 first indicated an increased risk for conditions such as cardiovascular disease, stroke, heart attack and death, yet the drug has remained on the market.
The FDA’s most significant action short of recall, a Black Box warning was issued in November of 2007, but many consumers and physicians were still unaware of the dangers.
The use of Avandia can increase the risk of major cardiac events by as much as 43% in patients who are already at a heightened risk due to their Diabetes. An FDA advisory panel that met in July 2010 was split on the decision to discontinue use of the drug, with about half the advisory group desirous for a recall and the other half arguing for only a stronger warning.
Action in the best interests of consumers has finally been taken, and substantial restrictions have been placed on the drug that will make it nearly impossible to obtain.
Patients who are currently using the medication should not discontinue taking Avandia, but they should immediately consult with their physicians to consider an alternate course of treatment.
To continue the drug regimen, patients and physicians will have to attest that Avandia is the only drug that is effective for the patient and the patient will be required to sign documentation of informed consent before they are allowed to refill their existing prescriptions.
Avandia’s primary rival Actos, a drug manufactured by Takeda Pharmaceuticals, which doesn’t carry the same warnings is currently available to diabetics. These new rules may just be postponing the inevitable, allowing the FDA some more time to gather better information which we hope will lead to an overall withdrawal of the drug from the market, such as that ordered in Europe.