FDA to Lift Restrictions on Diabetes Drug Avandia
Not all experts are happy with granting wider access to the troubled medication, however
Not everyone agreed with him, however.
Dr. Yehuda Handelsman, an endocrinologist in Tarzana, Calif. and incoming president of the American College of Endocrinology, applauded the FDA for "doing what's right by standing up for the science."
"I thought it was about time. Many of us never thought the information brought against the drug was very scientifically solid or correct," Handelsman said of the announcement.
For his part, Dr. Bob Eckel, a past president of the American Heart Association, greeted the news with more of a shrug.
"I think they've made the appropriate decision based on the updated evidence," Eckel said. "It's consistent with the latest evidence."
Both Nissen and Eckel agreed that widespread use of Avandia is not likely to resume, regardless of the FDA's change of heart, because too many concerns have been raised regarding the drug's safety.
"The good news is physicians are not going to start using this drug again. It's basically an obsolete drug, so this will have no practical implications," Nissen said. "Who's going to use it? What patient is going to take it and what doctor is going to prescribe it, given everything we know?"
Another expert concurred. "The decision by the FDA is irrelevant in clinical practice," said Dr. Ronald Tamler, clinical director of the Mount Sinai Diabetes Center at The Mount Sinai Hospital in New York City. "Patients have been reading about increased risk of cardiovascular events with Avandia since 2007 and will not abandon their concerns overnight, despite the FDA decision. Moreover, a medication with similar properties, pioglitazone [Actos], is available as a generic drug at a much lower cost."
But Handelsman said Avandia -- or its generic form -- might still have a bright future.
It's entirely possible that Avandia could come back in generic form, and that diabetes doctors might start prescribing it again as a viable option to other medications. "For us, it's not a problem to use," he said.
In its heyday, Avandia was a blockbuster diabetes drug for maker GlaxoSmithKline, with about $3.2 billion in sales posted in 2006.
Under the FDA's decision, the drug's information will be changed to reflect that Avandia may be used along with diet and exercise to improve control of blood sugar in type 2 diabetes patients. Patients will be able to receive the medication through regular and mail-order pharmacies.