Tuesday, April 10, 2007

FDA Assesses Risks of Vioxx Successor Drug Arcoxia

Article in the New York Times -- FDA Weighs Risk of Vioxx Successor Drug, by the Associated Press.  Here's an excerpt:

New painkillers in the same class as Vioxx that increase the risk of stroke and heart attack shouldn't be approved if safer alternatives are available, according to federal documents released Tuesday.

That opinion came as a panel of government advisers prepares to weigh Merck & Co. Inc.'s proposed successor to its now-withdrawn Vioxx.

That puts the cardiovascular safety of the drug, called Arcoxia, front and center Thursday, when the panel of Food and Drug Administration advisers discusses whether to make a nonbinding recommendation that the prescription painkiller receive agency approval. Merck voluntarily pulled Vioxx from the market in 2004 after it was linked to a higher risk of stroke and heart attack when compared to dummy pills.

The FDA said its focus in evaluating Merck's application for Arcoxia, and all other drugs from that class, will be specifically on its risks to the cardiovascular system. Any nonsteroidal anti-inflammatory drugs, or NSAIDs, merit approval only if they fill an unmet need for a particular group of patients who have no relatively safer options available, the FDA said in a March 21 memorandum released Tuesday.

BGS

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