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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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Failure To Warn: Hundreds Died While Taking An Arthritis Drug, But Nobody Ale...
STAT Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients STAT But neither Roche nor the FDA has moved to change Actemra39s label to alert patients and doctors that potential risks turned up in the reports, as well as in clinical studies completed after the drug went on the market. Experts who examined the data at

Surprise Arthritis Drug Celebrex Shown As Safe As Ibuprofen And Naproxen Forbes
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

University Of Pennsylvania Should Rethink OverHyped Press Releases Forbes
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

Misplaced Trust: Why FDA Approval Doesnapost Guarantee Drug Safety DrugWatch... Misplaced Trust: Why FDA Approval Doesn39t Guarantee Drug Safety The U.S. Food and Drug Administration is supposed to protect Americans from harmful drugs. But in reality, FDA approval does not guarantee safety. Critics say and more raquo

Cempra: A PostCRL Perspective Seeking Alpha
Cempra: A Post CRL Perspective Seeking Alpha Cempra received a Complete Response Letter from the FDA on the company39s new drug applications for oral and intravenous Solithromycin for the treatment of community acquired bacterial pneumonia in adults. While approved by their Advisory Committee and more raquo

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Facts of Law about the vioxx fda health advisory

Facts of Law - Vioxx FDA Health Advisory