Three U.S. Food and Drug Administration officials, including FDA commissioner Margaret Hamburg, explained their decision, announced Thursday, to significantly limit access to GlaxoSmithKline’s type 2 diabetes drug Avandia and two other related medications.
The officials said the FDA sought to strike a balance between protecting the public against the potential safety risks of Avandia, also known by its chemical name rosiglitazone, and allow well informed patients who cannot control their blood sugar levels with other medications access to the medication.
“Rosiglitazone does have benefits in glycemic control. These benefits include reductions in short-term complications of hyperglycemia,” the Hamburg and her colleagues wrote in a perspective piece published online in the New England Journal of Medicine. “Against these benefits, we must assess the evidence of rosiglitazone’s cardiovascular risks. This evidence is concerning, but it is not definitive.”
In addition tolimiting access to patients, the FDA also canceled a clinical trial to compare Avandia to the only other drug in its class Actos, also know as pioglitazone. The trial TIDE could not continue “given the current state of the evidence [on Avandia’s cardiovascular risks] and the FDA’s recent actions.”
The perspective concluded that the wider controversy around Avandia’s safety “underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term.”
In addition to the FDA’s action to limit availability of Avandia Thursday, the European Medicines Agency suspended the medication, effectively removing it from the market there.
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