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Vioxx: Merck Ceo
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Vioxx is a brand name used by Merck & Co., Inc. ("Merck") to market and distribute rofecoxib tablets, a nonsteroidal anti-inflammatory prescription arthritis drug. Merck obtained FDA approval on Vioxx in approximately April 1999 via a New Drug Application on a fast-track, 6-month approval process. Merck began distribution and sale of Vioxx throughout the United States in approximately May 1999. Despite knowledge in its clinical trials and post-marketing reports associating Vioxx with hypertension and/or hypertension-related adverse health effects, Merck marketed and promoted Vioxx as safe and effective for persons with hypertension, or persons who had risk factors for stroke or cardiac problems.
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[T]he new Vioxx study was not the first to raise concerns about heart attack and stroke risk. "We have been concerned and aware of the potential for cardiovascular effects for the last few years," Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the day Merck announced the withdrawal. "This is not a total surprise."
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Recent studies show Vioxx users have a 50 percent greater chance of heart attacks and sudden cardiac death. Because of this finding Merck & Co decided to voluntarily remove the drug from the market. Just before this action the data safety monitoring board recommended halting a long-term study of Vioxx effects because of the increase risk of serious heart attacks and strokes
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Where was Goldman right after the Vioxx scandal hit? The stock is up from 26 to 50 since the scandal broke two years ago. The company’s cash position was solid, they still had a number of products in pipeline, and a new CEO completely changed the company’s direction. However, you wouldn’t have heard about any of that coming from the major banks. But after Merck
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The Vioxx attorneys arguing cases are expected to use the VIGOR study results and Merck’s reaction to them. The test was designed to see if Vioxx causes fewer gastrointestinal problems than naproxen, a drug that belongs to the same class of drugs as ibuprofen and aspirin. Upon Vioxx approval, the FDA still required Vioxx labeling to include the same digestive warning s that it requires on naproxen , despite claims that Vioxx was associated to a lower risk of the side effect. While VIGOR did show Vioxx had fewer gastrointestinal problems than naproxen, the unexpected discovery was that a person taking Vioxx had a higher risk of heart attack and stroke than someone taking naproxen.
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The Vioxx recall is considered a huge blow to Merck. Vioxx is one of Merck's most popular drugs and since its 1999 introduction, 91 million Vioxx prescriptions have been written in the U.S. alone. In April 2002, the FDA implemented Vioxx labeling changes after Merck submitted a safety study in June 2000 finding an increased risk of serious cardiovascular event s , including heart attacks and strokes, in patients taking Vioxx compared to those taking naproxen. A recent FDA study found patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death compared to those taking Pfizer's arthritis treatment Celebrex . Other studies in patients taking Vioxx have ... suggested the increased risk of cardiovascular events to be present.
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