October 21st, 2010
News Briefs: Recurrent Stroke Prevention Guidelines, Vernakalant Trial Suspended, GSK Investigated, Generic Enoxaparin Takes Off, Kaul Speaks, Midei Sues
Larry Husten, PHD
The American Heart Association published revised recurrent stroke prevention guidelines. The new guidelines state that recurrent stroke may be prevented by carotid angioplasty or by treating metabolic syndrome.
The FDA warned about arrhythmias tied to HIV therapy. The FDA today updated the label for Invirase (saquinavir), noting that when used in combination with Norvir (ritonavir) it can prolong the QT or PR interval.
Cardiome announced the suspension of enrollment in the ACT 5 Trial, a phase 3b randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of vernakalant in patients with recent onset atrial fibrillation. The trial was stopped when one patient went into cardiogenic shock after receiving vernakalant. The FDA is reviewing data from the case.
GlaxoSmithKline revealed in its third-quarter earning statement that it had received a supoena from the U.S. Department of Justice relating to the Avandia controversy. In addition, several state attorneys general offices have initiated queries.
Generic enoxaparin is on the path to being a blockbuster. Launched in July by Momenta Pharmaceuticals, M-Enoxaparin had sales of $292 million in its first 69 days on the market.
FDA advisory panel member Sanjay Kaul explained to a Forbes reporter why he voted against the new obesity drug lorcaserin.
TheHeart.Org reported that embattled interventional cardiologist Mark Midei has filed a lawsuit of his own to counteract charges brought by his Maryland hospital that he implanted hundreds of stents without a proper indication.
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