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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 In 2008, when FDA scientific advisers met at a Silver Spring, Md., hotel near the agency39s headquarters to debate whether to recommend approval of Actemra, they were haunted by a notorious error just a few years earlier. Vioxx, another arthritis drug

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 dilemma. Celebrex was still on the market and other COX 2 inhibitors were in late stage development. Was the increased cardiovascular CV risk seen unique to Vioxx, or did all 10 year study eases concerns about Celebrex, heart riskCNN Celebrex Is Found to Be No Riskier for Hearts Than Other Pain DrugsNew York Times Frequently Asked Questions FAQs Basics Arthritis CDCCenters for Disease Control and Prevention all 216 news articles raquo

FDA Strengthens Warning On Prescription Medications Like Motrin, Aleve Dalla...
CNN FDA strengthens warning on prescription medications like Motrin, Aleve Dallas Morning News The FDA said Thursday that for now, only prescriptions NSAIDs would be required to add the warnings. But the agency said it would soon ask the manufacturers of over the counter NSAIDs such as ibuprofen Advil, Motrin and naproxen Aleve also to Stronger Warnings on 18 NSAIDs After Review Finds Increased Cardiovascular RiskRegulatory Focus FDA adds heart attack and stroke warning to some painkillersCNN all 340 news articles raquo

University Of Pennsylvania Should Rethink OverHyped Press Releases Forbes
Forbes University of Pennsylvania Should Rethink Over Hyped Press Releases Forbes After reading this press release, one has to wonder if the FDA was negligent in allowing such a dangerous drug like Celebrex to stay on the market. However, when the FDA reviewed this field in a highly unusual three day advisory committee meeting in

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Facts of Law about the vioxx fda health advisory

Facts of Law - Vioxx FDA Health Advisory