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

Vioxx, Market Withdrawal

Vioxx was voluntarily withdrawn from the U.S. market on September 30, 2004 by manufacturer Merck.  The Vioxx market withdrawal was in answer to studies indicating a higher risk of cardiovascular event in regular users of Vioxx.

A study on Vioxx (VIGOR study) was published in 2000.  It indicated a 4 times increase of risk of heart attack or stroke in Vioxx (rofecoxib) patients compared to patients taking naproxen over a 1 year period.  Merck's researchers concluded the findings of the study showed a protective effect of naproxen in reducing heart attacks in high cardiovascular risk patients.

Merck commenced a study (APPROVe study) in 2001 to evaluate the effects of Vioxx on colorectal polyps.  The study also intended to further evaluate the cardiovascular risk of Vioxx.  The study was ended early when results showed patients taking Vioxx were at increased risk of cardiovascular risk compared to patients taking a placebo after 18 months on the therapy.

Merck voluntarily withdrew Vioxx from the market on September 30, 2004 after the APPROVe study was ended early.  In the same month, the FDA also provided Merck with new research that further supported increased risk of heart attack among Vioxx users.


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FDA Advisory Panel Says Celecoxib Is As Safe For Heart As Ibuprofen And Napro...
TCTMD FDA Advisory Panel Says Celecoxib Is as Safe for Heart as Ibuprofen and Naproxen TCTMD PRECISION was launched in the wake of the rofecoxib Vioxx Merck fiasco. Celecoxib, which was approved in 2001, was allowed to remain on the market but only if Pfizer, the drug39s manufacturer, conduct a large scale cardiovascular safety trial and more raquo

FDA Drug Approvals Enjoy Positive Trend
FDA Drug Approvals Enjoy Positive Trend of the Prescription Drug User Fee Act. Despite early success with the law and subsequent amendments, a negative trend arose after Merck39s voluntary market withdrawal of COX 2 inhibitor Vioxx in September 2004 due to cardiovascular safety concerns.

Still Feeling The Vioxx Pain The Pharmaceutical Journal
The Pharmaceutical Journal Still feeling the Vioxx pain The Pharmaceutical Journal However, in 2005, the year after Vioxx39s withdrawal, prescriptions for Celebrex had fallen to around 800,000. Although it39s still on the market today, by 2013, the number of Celebrex prescriptions had fallen to just under 340,000. In 1999, there were

Vioxx Pulled From Global Market Medscape
Vioxx Pulled From Global Market Medscape Sept. 30, 2004 Merck amp Co., Inc., announced today a voluntary withdrawal of rofecoxib Vioxx from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events, according to an alert from MedWatch, the U.S. Food

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Facts of Law on the vioxx market withdrawal

Facts of Law - Vioxx Market Withdrawal