WASHINGTON (AP) — The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.
The repeal means patients will no longer have to enroll in a special registry to be eligible to receive the drug. Additionally, the drug will be available at most pharmacies, whereas it was previously limited to certain registered pharmacies. Those safety restrictions and others were put in place in 2010, severely curbing U.S. prescriptions for the GlaxoSmithKline drug.
Monday’s ruling is a belated victory for the British drugmaker, which has spent more than a half-decade defending the safety of Avandia, once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks. After three years of debate, the FDA limited access to the drug in 2010.
But FDA regulators said Monday a more recent analysis of a key Avandia study shows that the drug’s heart risks are no greater than other diabetes drugs.
“Given these new results, our level of concern is considerably reduced,” said FDA drug center director Dr. Janet Woodcock, in a statement.
The announcement also represents a vindication of sorts for FDA leadership, including Woodcock, who only agreed to put restrictions on the pill after years of pressure from outside researchers, safety advocates and several members of Congress.
Dr. Steven Nissen of the Cleveland Clinic, whose research first raised concerns about Avandia, said the announcement “is about the FDA’s effort to save face.”
“This is about appearances, not changing medical practice,” said Nissen, who chairs the Cleveland Clinic’s department of cardiology. “A single reanalysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.” Nissen said he doesn’t expect doctors to return to prescribing the drug, considering how many newer diabetes drugs are now available.
Nissen drew attention to Avandia’s safety in a 2007 study pooling thousands of reports of heart attack and stroke from dozens of unrelated studies involving the drug. His so-called meta-analysis combined 42 studies and showed a higher risk of heart attack among patients taking Avandia compared to other diabetes drugs.