After hearing a blistering review of Arcoxia's safety profile from the FDA's Dr. David Graham, a federal advisory panel voted 20 to one against recommending the controversial painkiller. "What you're talking about is a potential public health disaster," Graham told the receptive committee, effectively nailing the door against Merck's drug, which could have been responsible for an estimated 30,000 heart attacks in the U.S. each year. Merck sells Arcoxia in 63 countries. But it had to defend safety studies showing that Arcoxia was responsible for three times as many heart attacks, deaths and strokes than naproxen while it was no more effective at controlling pain. A number of panelists heaped criticism on Merck for filing for approval on a therapy that carried significant safety risks without offering any significant benefit not already provided by existing therapies. Merck representatives, who hoped to see Arcoxia succeed Vioxx, said they were disappointed by the vote. The FDA still has to make a final decision, but the overwhelmingly negative reception by the panel leaves agency officials little room to maneuver.
- here's the release on the FDA's decision
- read the report on the vote from The New York Times
ALSO: What would normally have been a black moment for Merck investors ended on a distinctly bright note: Shares of the company hit a 52-week high today after the company raised its earnings forecast and said that a federal judge has dismissed a class-action suit related to Vioxx. Report
Related Articles:
Arcoxia vote may have big impact on Novartis. Report
FDA panel to consider case for Arcoxia. Report
Cardiologists slam Merck on Arcoxia data. Report
FDA whistle-blower attacks safety of Arcoxia. Report
Merck presents Arcoxia data. Report