Should Avandia be pulled from the market?
That’s the key question the Food and Drug Administration (FDA) must decide as it meets this week to ponder the fate of GlaxoSmithKline’s (GSK) controversial diabetes drug, which some studies have linked to increased risk of heart attack, stroke, and death.
Two recent news reports have made Avandia’s position even tougher on the eve of this critical meeting at which an expert panel will assess the drug’s safety and recommend whether it should remain on the market. First, The New York Times reported that an FDA reviewer last week issued a devastating critique of the clinical study used by GSK to refute safety claims lodged against Avandia.
The reviewer found that the so-called Record study failed to count at least twelve instances in which patients who used Avandia may have suffered cardiovascular problems, reports the Times. GSK stands by the study’s results, which will be part of the data reviewed by the FDA panel this week. Meanwhile, Bloomberg News reported that a former FDA official has alleged that GSK did not share with federal regulators a study showing that Avandia might pose a greater heart attack risk than some other diabetes drugs.
The allegation was made by Dr. Rosemary Johann-Liang in a deposition she gave in a lawsuit filed against GSK, according to Bloomberg. GSK took issue with Johann-Liang’s account and told the news service that no studies have proven that Avandia is dangerous. Avandia (rosiglitazone) has come under increasing scrutiny since February, when the FDA and the US Senate released reports critical of cardiac risks associated with it. But the drug has been embattled since 2007, when a study by the Cleveland Clinic linked it to an increased risk of heart attack.
The FDA issued a safety alert for Avandia that same year. GSK has defended Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.
As always, do not change any medication without first consulting your doctor.