April 14, 2013
FDA Advisory Panel To Re-Evaluate Diabetes Drug Avandia In June
redOrbit Staff & Wire Reports — Your Universe Online
Three years after restricting sales of Avandia, the US Food and Drug Administration (FDA) has scheduled a health advisory panel to re-evaluate the safety of the diabetes drug, various media outlets reported on Friday.
The FDA limited the availability of the pill to patients who could not control their diabetes with any other medication due to an increased risk of heart attack and death associated with the product, according to Ransdell Pierson of Reuters. The drug´s producer, GlaxoSmithKline (GSK), estimates only 3,300 Americans are currently using the product, he added.
The British pharmaceutical giant told Reuters they did not petition US health regulators to expand availability of the drug. In Pierson´s article, Mary Anne Rhyne said the latest edition of the Federal Register reports the advisory panel will meet on June 5 and June 6 to discuss the medication. She also speculated the FDA will request an update from GSK on safety-related information first requested in 2010.
The FDA declined to allow officials to discuss why the two-day hearing was being held, claiming it was too early in the process to discuss what options might be considered for Avandia, according to Thomas M. Burton and Jeanne Whalen of the Wall Street Journal. Burton and Whalen called the reassessment hearing “unusual,” but noted it is not likely the diabetes drug will become available to more patients as a result of the meetings.
“The hearing could alter the historical record of an episode that was embarrassing for Glaxo and involved the airing of sharp scientific disagreements within the FDA,” the Journal reporters said. “The earlier research, published in the medical journal The Lancet in June 2009, found that use of Avandia with other glucose-lowering therapy increased the risk of some fractures — mainly in women — and of heart failure. The study found, however, that data were inconclusive regarding evidence of heart-attack risk.
“In July 2010, FDA scientists said the study, known as the Record trial, was flawed and that it may have undercounted the number of heart attacks among people taking the drug,” Burton and Whalen added. “The Avandia problems cost Glaxo dearly. In July 2012, the company agreed to pay the US government $1 billion in criminal fines and to plead guilty to criminal charges involving three drugs, including Avandia.”
The company also pleaded guilty to withholding safety-related information from American regulators between 2001 and 2007, including a pair of studies examining the diabetes drug´s potential heart-related safety issues.
Rhyne told Pierson a team of Duke University medical experts had re-examined the Record study and submitted the revised findings to the FDA. She also said the research found there was no significant difference between Avandia and two other widely prescribed oral diabetes drugs, metformin and sulfonylureas.
Forbes contributor Larry Husten speculates the June panel´s significance will be “quite limited.” Because Avandia is no longer on sale in Europe and has extremely limited availability in the US, Husten said he believes, while there may be “legal implications,” the overall “commercial and clinical implications of the panel will be minor.”