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February 26, 2005
Recent FDA Decision on Vioxx
An investor point of view on Vioxx, Celebrex, Bextra and COX-2 inhibitors vis a vis the FDA.
For more than four months, COX-2 inhibitors like Vioxx, Celebrex, and Bextra have created monumental headaches for their makers, investors, patients, doctors, and regulators. As concerns over elevated risks of heart attack and stroke mounted, Merck (NYSE: MRK) withdrew Vioxx, and Pfizer (NYSE: PFE) faced increasing pressure to do the same with Celebrex and Bextra.
Pummeled by the reality of lost sales and the fears of potential lawsuits, Merck shareholders have suffered in the wake of the company's voluntary withdrawal of Vioxx. Though Pfizer didn't suffer quite as much, the stock still came under pressure as investors feared the possibility of withdrawal and future lawsuits.
Now it looks as though COX-2 inhibitors will stay on the market after all. On Friday, an FDA advisory panel summoned to evaluate the safety of Vioxx, Celebrex, and Bextra (and COX-2 inhibitors in general) gave its blessing to permitting sales of all three drugs. Although the FDA is not obligated to follow the advice of its specialty panels, it generally does.
It should be noted that the FDA panel was not exactly overwhelmingly supportive of COX-2 inhibitors. Rather, the panelists acknowledged that other painkillers have high risks as well and that the risk-benefit analysis of using COX-2 drugs was best left between physicians and their patients.
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Posted on February 26, 2005 11:46 AM by Vioxx68.
Filed in Personal Injury Resources under vioxx.
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