Posts Tagged ‘cardiovascular risk’

VIOXX - What Could Have Been in the Age of REMS

Monday, February 15th, 2010

- Guest blog by Wendy Kaplan Nickel -

Perhaps one of the greatest downfalls in drug history was the steep tumble of VIOXX after it was voluntarily pulled from the market in 2004.  VIOXX was approved by the FDA in 1999 and quickly became “the” drug for arthritis.  It gained widespread acceptance among physicians and over 20 million people were prescribed VIOXX at some point in its 5-year tenure.  In fact, in the year prior to VIOXX’s withdrawal from the market, its manufacturer, Merck, experienced sales revenue of $2.5 billion from VIOXX alone.  It is assumed Merck certainly had no intention of harming patients with its product, and in fact, celebrated in the fact that so many patients benefitted from the medication.  However, it is worth exploring what might have happened if VIOXX’s safety issues had been discovered during the post-FDAAA era.

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