Vioxx

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Vioxx, FDA Health Advisory - Sept 30, 2004

On September 30, 2004, and FDA Health Advisory was issued announcing that Merck was announcing a voluntary withdrawal of Vioxx from the market due to safety concerns.  Vioxx was a commonly prescribed drug in the non-steroidal anti-inflammatory drug (NSAID) family.  It was approved by the FDA in 1999 for the management of pain and inflammation and was widely prescribed to arthritis sufferers.

A long term study of Vioxx on patients suffering from recurrent colon polyps was stopped early in September 2004 for safety reasons.  Subjects of the study using Vioxx showed an increased risk of heart attack and stroke compared to subjects taking a placebo.  Merck voluntarily pulled Vioxx from the market on September 30th.

 

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Lilly39s baricitinib wins FDA panel nod, but still dogged by safety issues BioPharma Dive While the FDA normally follows suit with advisory committee votes, the unresolved data issues surrounding baricitinib could spur an unusual departure, or at the very least a restricted label. quotAny panel discussion that includes comparisons to Vioxx and more raquo

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Facts of Law about the vioxx fda health advisory

Facts of Law - Vioxx FDA Health Advisory