The panel was satisfied with the results and largely agreed that these concerns were allayed and that the RECORD results could be considered along with the other studies that provided safety data on rosiglitazone, although none were ideal.
One of the panelists who voted to keep the REMS as it exists, Dr. Maria Suarez-Almazor of University of Texas MD Anderson Cancer Center, Houston, said she voted for no change because "there were consistent signals for MI in the observational data and also in the RECORD trial," and although they were not statistically significant, she did not see a clear benefit of using this drug over pioglitazone, other than the bladder cancer issue.
In 2011, 59% of all available rosiglitazone products, including combination products that contain the drug, were in retail pharmacies, and 34% were available through mail-order pharmacies. In 2012, 97% were in mail-order pharmacies and less than 0.1% were in retail pharmacies, according to the FDA. Between July 2007 and July 2010, 1.6 million patients received prescriptions for rosiglitazone, dropping to about 4,600 patients in 2012. Based on national prescription data, between May 2011 and December 2012, after the REMS was put in place, rosiglitazone was most commonly prescribed by physicians in family or general practice (about 52% of prescribers) and internists (about 32%), followed by endocrinologists (almost 4%), according to the FDA. These proportions are similar to the period from 2007, up until the REMS.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting.
In a statement released by GSK shortly after the panel meeting ended, Dr. James Shannon, GSK’s chief medical officer, said that the company "will continue to work with the FDA as it considers the recommendation of the committee." Rosiglitazone was approved by the FDA in 1999. Earlier, on the first day of the meeting, GSK indicated that it had no plans to market rosiglitazone or any products containing it.
emechcatie@frontlinemedcom.com
Correction, 06/07/2013: An earlier version of this story misstated the organization that commissioned the reanalysis of the data.
Correction, 06/12/2013: An earlier version of Dr. Nissen's video interview incorrectly stated that the rest of the world had banned rosiglitazone. The drug remains available in some countries, in addition to the United States.
Correction, 06/12/2013: An earlier version of this story misstated Dr. Smith's vote.