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Facts - Books - News    U.S. Facts Of Law:

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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Forbes Surprise Arthritis Drug Celebrex Shown As Safe As Ibuprofen And Naproxen Forbes Merck immediately withdrew Vioxx from the market. However, the FDA was in a To help with this problem, the FDA called a joint meeting of their Arthritis Advisory Committee and the Drug Safety amp Risk Management Advisory Committee. This meeting 10 year study eases concerns about Celebrex, heart riskCNN Celebrex Is Found to Be No Riskier for Hearts Than Other Pain DrugsNew York Times all 216 news articles raquo

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Forbes University of Pennsylvania Should Rethink Over Hyped Press Releases Forbes Just before Celebrex and Vioxx were approved and launched, a group led by Garret FitzGerald, MD, chair of the department of Pharmacology, and Director of the Institute for Translational Medicine and Therapeutics at Penn, observed that both drugs

Approving A Muscular Dystrophy Drug Ignites A Civil War At The FDA Forbes
Forbes Approving A Muscular Dystrophy Drug Ignites A Civil War At The FDA Forbes Worse, the FDA had issues with the way Sarepta had tested dystrophin. After the FDA39s April advisory committee voted that the drug should not be approved, the FDA and Sarepta agreed to look at one more set of data points: Samples would be taken from and more raquo

AposTough As Nailsapos: Storm Swirls Around FDA Drug Cop Who Approved Controv...
STAT 39Tough as nails39: Storm swirls around FDA drug cop who approved controversial drug STAT She39s one of the best witnesses the FDA can send to Capitol Hill because she knows far more than the people asking the questions and she39s definitely not afraid, said Ira Loss, a Washington policy analyst who has tracked the FDA for 40 years. The

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Facts of Law about the vioxx fda health advisory

Facts of Law - Vioxx FDA Health Advisory