An FDA panel wants to loosen restrictions on Avandia, a highly-regulated diabetes drug that can increase the chance of heart attack, according to Medpage Today.
The harsh restrictions have caused the number of patients who are prescribed the drug to fall from 117,000 to 3,400. The drug has been completely banned in Europe.
In the U.S., physicians and pharmacies must both have special certifications in order to prescribe and dispense the drug. The FDA may decide to loosen the risk evaluation and mitigation strategy (REM) by allowing doctor's and pharmacies that don't have this certification to dispense the drug.
An FDA advisory committee voted on the subject on Thursday, out of 26 panelists, 20 voted to loosen restrictions of the substance.
Out of the remaining six panelists, five voted to leave the REMs as they are, one voted to remove the drug from the market.
Of the 20 panelists who voted in favor of loosening restrictions, 13 voted to modify the REMs and seven voted to completely remove them.
The restrictions were originally put in place following a panel meeting in 2010. The panel claimed her were problems with the manufacturer GlaxoSmithKline's drug trial method and outcome .
The panelists raised concerns over the method to collect the data regarding the safety of the drug, and the interpretation of it. The drug's trial was not blinded and open-label which leaves the concern that bias could occur, tainting the results.
The panelists asked that a new study be conducted that was controlled and randomized in order to better learn about the risk facor associated with the drug, but this may not be possible with the amount of publicity Avandia has gained over the past few years.
"It may well not be feasible to conduct a trial that answers the questions we have," said Susan Heckbert, said MD, PhD, epidemiology professor at the University of Washington.
It will now be up to the FDA to make a decision about the drug's restrictions, they are not required to follow the advice of their panel, but they do most of the time.
"I find no substantial evidence or information that rosiglitazone (Avandia) is unsafe," said Arthur Moss, MD, cardiology professor at the University of Rochester School of Medicine in New York.
Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical believes that there's not enough evidence supporting the fact that Avandia's high risk and that doctors should be able to prescribe it as they see fit.
