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drug_recall vioxxVioxx was introduced to the U.S. market in 1999. More than 100 million Vioxx prescriptions have since been written for Vioxx, and about two million people worldwide currently use Vioxx. When Merck & Co. announced September 30, 2004 it was voluntarily withdrawing Vioxx from the market, more questions than strictly Vioxx recall concerns extended. The largest voluntary drug recall in history, Merck halted a study after confirming Vioxx raises the risk of heart attack and stroke in patients. Though Merck was commended by some for its decision to announce a Vioxx recall, many critics remained, questioning why it took five years to realize the potentially deadly risks.
Following the Vioxx recall, Senate Finance Committee Chair Chuck Grassley said in a statement that he was concerned the FDA might have been “foot dragging” in terms of adequate safety actions in regard to Vioxx. The FDA has been under attack in recent years for its lack of aggressiveness to oversee medicines after reaching the shelves and for the way drug companies are able market its treatments directly to consumers without sufficiently emphasizing potential drug risks.
In 2000, initial risk of Vioxx safety concerns emerged and by 2001, a report in the Journal of the American Medical Association found signs the drug might increase the risk of cardiovascular disease. The 2001 study findings were not added to Vioxx''s label until April 2002 when the FDA requested it. Public Citizen consumer group had warned consumers in April 2001 to avoid the use of Vioxx, and following the announcement of the Vioxx recall, Dr. Sidney Wolfe, director of health research at the advocacy group, sharply criticized the FDA for failing to require longer studies after the initial evidence of Vioxx safety risks in 2000 surfaced.
The Vioxx recall has led the FDA to work on ways to improve how it detects and responds to risks from medical products, focusing on improving data-mining of adverse events by using electronic filing to process reports, examining health care provider data, improving the design of clinical trials and promoting research on pharmacogenetics to help identify people who might react adversely to drugs. In addition, the FDA is considering requiring companies to perform definitive clinical studies specifically addressing safety issues following a drug''s market entrance, as well as considering if longer studies should be required for COX-2 inhibitors, the class of drugs Vioxx belongs to, to better ensure another Vioxx recall repeat is avoided.
Even before the Vioxx recall was announced, numerous Vioxx related lawsuits, in addition to two seeking class action status, had been filed against Merck. After the Vioxx recall was made, a flurry of lawsuits was filed on behalf of patients worldwide. Legal analysts have made predictions for the surge of Vioxx lawsuits expected since the Vioxx recall announcement was made. Estimates for Merck''s potential litigation costs have been predicted to reach more than $1 billion, though others predict the number to be much lower. Either way, analysts and attorneys alike agree that a flood of Vioxx lawsuits will be filed, which Merck has said it will create a reserve to help cover.
Following announcement of the Vioxx recall, some insurers felt their decisions were finally justified after a few large health insurers restricted access to the drug. Group Health, a non-profit HMO in Washington was one of the insurers to limit Vioxx over the years stating, “we had concerns about safety of Vioxx from the very beginning based on unpublished data on the FDA Web site.” With global sales of $2.5 billion, the Vioxx recall is anticipated to make many waves in days to come.
Two reports released Wednesday reveal that Merck waged a deceptive promotional campaign for its top-selling painkiller Vioxx and disguised company studies as the work of outside scientists.
JAMA Studies
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The third-largest drugmaker in the U.S, Merck, agreed to settle a majority of their claims involving the painkiller Vioxx for $4.85 billion.
The settlement is reportedly the larg...
An Idaho state jury has found that the painkiller Vioxx contributed to the heart attack of a postal worker. The jury awarded him and his wife a multimillion-dollar verdict.
Frede...