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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Vioxx was voluntarily withdrawn from the U.S. market on September 30, 2004 by manufacturer Merck.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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Still Feeling The Vioxx Pain The Pharmaceutical Journal
The Pharmaceutical Journal Still feeling the Vioxx pain The Pharmaceutical Journal On 30 September 2004, Vioxx rofecoxib, a non steroidal anti inflammatory drug NSAID that had been on the market since 1999, was suddenly withdrawn by its manufacturer MSD owing to concerns about its effect on cardiovascular health. The legacy of

Potential Praluent Withdrawal Leaves Uncertainty For Cardiologists Medscape
Medscape Potential Praluent Withdrawal Leaves Uncertainty for Cardiologists Medscape A District Court judge has ordered Sanofi and Regeneron Pharmaceuticals to take alirocumab Praluent off the US market. The decision, along with the anticipated appeal of the order, has left the cardiology field with a bit of uncertainty and a concern and more raquo

Vioxx Pulled From Global Market Medscape Subscription
Vioxx Pulled From Global Market Medscape subscription 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

Investing In Drug Safety Monitoring Could Avoid Complications And Save Medic...
Investing in drug safety monitoring could avoid complications and save medical costs EurekAlert press release Three recent cases in which serious safety issues led to medication withdrawals illustrate the potential return on investment of building a more effective pharmacovigilance surveillance system, according to the report by Krista F. Huybrechts, PhD, of and more raquo

More Harm Than Good: When Drugs Are Removed From The Market BMC Blogs Networ...
BMC Blogs Network blog More harm than good: when drugs are removed from the market BMC Blogs Network blog Some of those drugs, such as rofecoxib Vioxx were among the most prescribed medicines in the country. This reality should make anyone who has the authority to prescribe a drug cautious, especially when it comes to new drugs where safety information

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Facts of Law on the vioxx market withdrawal

Facts of Law - Vioxx Market Withdrawal