The RESULTS are in! A panel of FDA advisers thinks it is time to alleviate restrictions currently in place for the antidiabetic drug, Avandia (rosiglitazone). Of the 20 panelists who voted to remove or modify the current labeling and distribution center, 13 voted to modify it while the remaining 7 voted to remove the REMS entirely.
The one-time multimillion dollar blockbuster drug dropped dramatically in usage due to reports that it increased the risk of heart attacks. Back in 2010, the FDA placed severe restrictions on the drug following concerns that were raised regarding an increased risk of cardiovascular events; the European regulators banned the drug altogether. In this decision, the Agency required a re-examination of the drug manufacturer’s, GlaxoSmithKline (GSK), RECORD trial as the trial’s methods and reliability of results were questioned. This six-year study of 4,400 patients was the only large, randomized trial of rosiglitazone. Adjudication results were presented before the FDA panel this week for review, and put many of those concerns to rest according to many of the panelists.
Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, stated that there’s not enough evidence to support or blame rosiglitazone’s safety and therefore physicians should be able to choose it if they desire.
The decision is now in the hands of the FDA. The FDA is not obligated to follow the advice of its advisory committees but usually does.
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