FDA panel urges looser restrictions on diabetes drug Avandia
POSTED: Thursday, June 6, 2013 - 6:12pm
UPDATED: Thursday, June 6, 2013 - 6:12pm
(CNN) — In a reversal of its past position, a majority of a 26-person Food and Drug Administration advisory panel voted Thursday to recommend looser restrictions on the controversial diabetes drug Avandia.
Thirteen members voted to modify the current restrictions, while another seven voted to remove them altogether. Five members voted to continue the restrictions without changes, while one voted to remove Avandia from the market.
The decision whether to act on the recommendation now lies with FDA Commissioner Margaret Hamburg.
In 2010, the FDA restricted Avandia use to patients with type 2 diabetes who could not control their illness with other medications.
The decision was based on studies showing an increased risk of serious heart problems in patients taking Avandia, most notably a 2007 analysis by Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, showing a 43% increase in heart attacks.
The finding led the FDA to order GlaxoSmithKline (GSK), the drug's maker, to conduct a thorough study of its safety. The full results of that study -- known as RECORD -- were made public in 2009.
While GSK said the safety data was reassuring, the study was heavily criticized by Dr. Thomas Marciniak, an FDA scientist who reviewed the data and said GSK ignored several cases of patients who suffered severe adverse effects.
Because there were multiple, conflicting signals of cardiovascular risk associated with the drug, Dr. Janet Woodcock, director of CDER, the FDA's Center for Drug Evaluation and Research, recommended GSK commission an outside, independent group to review RECORD's results.
GSK chose the Duke Clinical Research Institute (DCRI) to re-examine the data. It was the results of the DCRI review that prompted this latest two-day hearing.
DCRI's associate director, Dr. Kenneth Mahaffey, said DCRI performed a comprehensive review and its data was consistent with GSK's initial trial results.
Some members of the FDA panel questioned the severity of the current restrictions and the scope of cardiovascular events caused by taking the drug.
"I am considerably reassured ... that the magnitude of risk is not great," said Dr. Dale Hammerschmidt, one of the panelists who voted to modify the warning. He added he thought the current warning was more severe than necessary, but should not be removed entirely.
GSK said it will continue to work with the FDA as the panel's recommendation is considered.
"We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling," said Dr. James Shannon, GSK's chief medical officer.
Currently, only 3,000 patients in the United States are registered to take Avandia, according to GSK spokeswoman Mary Ann Rhyne. That's compared to the 120,000 patients taking the drug in 2010 before the restrictions were put in place.