Controversy Surrounds FDA Panel's Unanimous Vote to Approve New Antiplatelet Agent Prasugrel

Henry I. Bussey, Pharm.D.
February, 2009

According to theheart.org, the FDA panel voted to recommend approval of prasugrel, a clopidogrel-like drug, but concerns persist about the bleeding risk and a possible carcinogenic potential. Because of an increased bleeding risk, there was concern that use should be limited or the dose reduced in patients weighing 60 kg of less and/or those 75 years of age and older. It also may be contraindicated in patients with a history of stroke or transient ischemic attack. Finally, the concern about cancer deaths stems from findings in the TRITON-TIMI-38 study in which there were 33 deaths in the prasugrel group and 21 in the clopidogrel group; some consider this a spurious finding.

The panel's vote was unanimous, but the makeup of the panel has raised concern in the medical field. Specifically, in a very controversial move, Dr. Sanjay Kaul was excluded from the FDA advisory panel. Dr. Kaul is a vascular physiology expert at Cedars-Sinai Medical Center in Los Angeles, CA and has been openly critical of prasugrel. Many in the industry are asking why he was excluded from the panel and are suggesting that the panel was "designed" to approve this drug. The links below include more information on the controversy:

1. Red flags raised over FDA advisory-panel hearing on prasugrel
   
   
2. "Mistakes" made: FDA acknowledges Lilly phoned to question Sanjay Kaul's inclusion on prasugrel panel

Note that this story is reporting the action of an FDA PANEL; this is NOT the final FDA approval. The panel votes to recommend a particular action to the FDA, and the FDA usually - but not always - follows the recommendation of the panel. So this action probably will result in FDA approval, but it does not assure FDA approval.