If ever there were a case study in the messy uncertainties of drug development, the diabetes drug Avandia (rosiglitazone) would be a prime candidate. On 25 November, US regulators removed safety restrictions that had been placed on the drug in 2010 following concerns about heart risks. After years of debate and deliberation, Avandia can be marketed and prescribed freely again, even though, by now, sales of the drug have plummeted as people with diabetes turn to other options.
In June, advisers to the US Food and Drug Administration (FDA) voted that warnings about cardiovascular safety should be revised in light of a re-evaluation of key clinical trial data, but the advisers differed in their opinions about what those changes should entail. (See our June blog post for more on the twists and turns leading up to that vote.)
Yesterday, the FDA announced its conclusion: results from a clinical trial known as RECORD failed to confirm the heart concerns highlighted in a 2007 analysis of earlier clinical trials.“Given these new results, our level of concern is considerably reduced,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research in a statement. “Thus, we are requiring the removal of certain prescribing restrictions.” The FDA plans to make the drug available to most patients with type 2 diabetes and to remove restrictions on who can prescribe the drug.
The European Medicines Agency (EMA), which pulled Avandia from European pharmacies in 2010, said in a statement that Avandia’s maker, pharmaceutical giant GlaxoSmithKline, has not asked for a re-evaluation of the drug. “Should it be asked to do so, the EMA will assess the total evidence carefully and consider any appropriate action,” it said.