FDA Advisory Panel to Reevaluate Safety Issues Surrounding Banned Diabetes Drug Avandia
The Food and Drug Administration (FDA) is reviewing the popular diabetes drug Avandia which was banned in 2010 after researchers found that thousands of people had heart problems after taking it.
The drug, which has also been banned in most countries around the world, will be the topic of discussion in Wednesday's meeting where a new FDA advisory committee will take two days to reconsider whether it's safe again for consumption or not.
Experts could recommend lifting restrictions on the drug, among other options, the New York Times notes.
The GlaxoSmithKlinebillions produced drug received a positive safety review from Duke University researchers, saying it does not pose any heart risk in a study called RECORD. The FDA says in briefing documents released on Monday that it vowed to reassess Avandia once more data became available, which is why it is now gearing to revaluate the diabetes drug. The study followed 4,400 patients and tracked rates of heart attack, hospitalization and death for six years. The results were first reported in 2009 and medical experts have been debating their legitimacy ever since.
However, a previous FDA analysis of more than 50 studies linked Avandia to an elevated risk of heart attack; one study linked it to more than 47,000 cases of heart attack, stroke or heart failure from 1999 to 2009.
The FDA posted the opposing viewpoints on its website ahead of the two-day meeting of an advisory panel that will revisit the debate over the drug.
The drug was first approved in 1999, and quickly became the top-selling diabetes pill in the world by 2006 with sales of $3.4 billion. However, prescriptions plunged the following year after an analysis of dozens of studies suggested Avandia could increase the risk of heart attack.
European regulators, on the other hand, suspended the drug's marketing authorization in Europe at that time.
"It's the wrong reason to take a regulatory action," said Dr. Steven Nissen of the Cleveland Clinic, who authored the 2007 analysis that first raised public safety concerns about Avandia, the Associated Press notes.
"You want to take a regulatory action because it's going to benefit patients. I don't see how patients could possibly benefit from lifting these regulatory restrictions."