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FDA Advisory Committee Meets to Decide if Avandia Will Stay on the Market

In 2007, Dr. Steven Nissen and Kathy Wolski of the Cleveland Clinic published an analysis on the cardiovascular risk associated with Avandia (rosiglitazone) that sparked a controversy that is still burning strong (for our coverage of the issue, see Learning Curve from diaTribe #6). As a reminder, Avandia (made by GlaxoSmithKline) belongs to the thiazolidinedione (TZD) class of drugs for the treatment of type 2 diabetes, and there is currently only one other TZD available in the US and Europe called Actos (made by Takeda). Although Dr. Nissen’s analysis suggested Avandia could increase the risk of heart attacks by 43%, some physicians and statisticians had concerns about the validity of the study and questioned its conclusions. An FDA panel met on July 30, 2007 to deliberate on the controversy, and two weeks later, a black box warning was issued by the FDA for Avandia as well as Actos, emphasizing that TZDs may cause or exacerbate heart failure or bone fracture, especially in certain patient populations. Since that meeting, more studies and analyses have been published, including another by Dr. Nissen (reiterating his earlier conclusions) and the full results of the RECORD trial.

In April, 2010, the Senate Finance Committee published a scathing report criticizing both GlaxoSmithKline and FDA for the way that safety concerns about the drug were handled between 2007 and 2010. These events paved the way for yet another meeting of the FDA’s advisory committee this summer from July 13-14, this time to decide if the new evidence suggested Avandia should be taken off of the market and the ongoing safety trial for the drug (dubbed TIDE) be halted. We were at the meeting bright and early (the room was eventually standing-room-only), and after two days of deliberation, the committee voted 20 to 12 to keep Avandia on the market and continue the TIDE trial, with the majority of panelists suggesting further warnings or restrictions be added to Avandia’s label (FDA has since weighed in against the panel to say that no new patients should enroll in TIDE until further notice). While there is ongoing concern, most panelists did not feel there was sufficient evidence to warrant removal of the drug from the market and emphasized it may still be an important option for some patients. For now, we must wait for the FDA’s final decision (the advisory committee’s recommendations are technically only suggestions), but we note it is extremely rare for the FDA to go against the committee’s vote. The vote was complicated as there were actually five choices for panelists across a broad spectrum of agreement – such a wide range may enable FDA to more easily decide its own course, as there was no clear majority. We did find it notable that the panel seems to have little confidence in many doctors’ ability to explain risks to patients adequately. We will continue to follow this issue closely. --JS

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