An FDA advisory panel yesterday voted 20-12 to keep rosiglitazone (Avandia) on the market. The panel vote came after two days of intensive data review. Of the 20 members who voted not to remove the drug, the overwhelming majority recommended the drug include stricter labeling. Half of those votes suggested that rosiglitazone be restricted to prescription only by physicians with special knowledge in use of the drug. Some panelists also indicated that additional patient education is needed. Only three of the panelists voted to keep rosiglitazone on the market without additional product labeling. The 12 members recommending removal of rosiglitazone argued that pioglitazone works just as well without the added risks of ischemic events. 

The panel was also tasked with making recommendations in eight additional areas, including safety of rosiglitazone as compared to pioglitazone and other hypoglycemic drugs. In evaluating whether rosiglitazone presents greater risk compared to non-thiazolidinedione (TZD) diabetes drugs and pioglitazone, the panel voted 18-6 in favor of the notion that sufficient evidence exists to support an increased risk of ischemic cardiac events as compared to non-TZDs. Nine voting members were unable to make a decision on this specific point. The panel also voted 21-4 when asked to determine whether rosiglitazone is less safe than pioglitazone. Eight panel members were unable to decide.

In addition to voting on whether or not the drug should remain on the market and specific safety concerns relative to comparable drugs, the panel was charged with recommending whether or not TIDE, the ongoing international trial designed to compare rosiglitazone to pioglitazone with respect to risk of MI, should continue. In a 20-10 vote, the panel recommended that TIDE carry on (one panelist did not vote and another two were no longer present).

Though the FDA panelists failed to reach a unanimous consensus on any of the nine recommendations, they agreed the available data are confusing and additional information is needed. They also seemed to agree that many flaws exist in the data.

The FDA is expected to make a final decision on the fate of rosiglitazone in the coming weeks. Though the agency is not obligated to follow the recommendations of its panel, it often does. Stay tuned for updates as we learn more.

Mainstream Coverage:

• Washington Post
• USA Today
• Los Angeles Times
• Wall Street Journal 

UPDATE (7/19): Check out the coverage the ACC received in the WSJ's Health Blog, which talks about the difficulty doctors will face making recommendations about the drug to patients.