Vioxx Drug Recall
VIOXX and its Side Effects
Vioxx is a non-steroidal anti-inflammatory prescription drug prescribed to reduce pain inflammation and stiffness caused by arthritis. It has also been prescribed to manage pain in adults and to treat menstrual pain. Vioxx was first approved to treat arthritis in 1999, as well as other kinds of pain in adults. Vioxx is a member of the COX-2 inhibitor group of drugs which also includes Celebrex and Bextra. These drugs work to decrease swelling in effected joints. Recently, published data calls into question the beneficial advantages of Vioxx and raises questions of "serious cardiovascular events" related to the use of Vioxx. When compared to Naproxen users, Vioxx users were four times more likely to suffer from a heart attack.
In August of 2001, authors, Steven Nissen, a cardiologist at the Cleveland Clinic and Eric Topol, chairman of cardiovascular medicine and Debabrata Mukherjee, a clinic fellow, published an article in the Journal of American Medical Association saying the "available data raise a cautionary flag about the risk of cardiovascular events" with COX-2 inhibitors. Vioxx, they said, appeared especially risky. The article reported Vioxx was associated with a significantly elevated relative risk of cardiac complications, stroke or even death.
FDA ACTION
On September 17, 2001, the Food and Drug Administration issued a warning letter to Merck & Co., Inc., the manufacturer of Vioxx, for misrepresenting the safety of their prescription pain medication. According to the FDA, Merck's promotional activities and materials for Vioxx was misleading and in violation of the Federal Food, Drug and Cosmetic Act and applicable regulations.
In April of 2002, the FDA, following up on the advisory panel's advice from 2001, approved new labeling for Vioxx that pointed out the association with higher heart attack and stroke risk.
VIOXX REMOVED FROM MARKET
Vioxx had sales last year of $2.55 billion. More than 100 million prescriptions have been written for Vioxx
since it went on the market in 1999. Vioxx has decreased in sales in recent
years due to suggestions that the drug led to heart problems. This suggestion was confirmed by the FDA leading Merck to remove Vioxx from the market.
Merck removed Vioxx from the market on September 30, 2004, when a recent global colon cancer trial confirmed long-standing concerns that the drug raises the risk of heart attack and stroke after eighteen (18) months of treatment in the patients taking Vioxx compared to those taking placebo.
A recent study by the U. S. Food and Drug Administration suggested patients taking Vioxx faced a 50% greater risk of heart attacks and sudden cardiac death that those taking Celebrex.
EVENTS LEADING TO WITHDRAWAL:
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May, 1999:
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Vioxx is launched in the U.S. and is marketed in more than 80 countries;
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2000:
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Trial enrollment begins for a study to determine the effect of three years of treatment with Vioxx on the recurrence of polyps of the large bowel.
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March 2000:
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Another study demonstrates that gastrointestinal risks with Vioxx are less than with naproxyn, but the study shows increased cardiovascular risk.
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February, 2001:
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FDA federal advisory panel concludes that Vioxx is safer on stomachs than rival drug, Celebrex.
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August, 2001:
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Cleveland Clinic study published in the Journal of American Medical Association associates Vioxx with cardiovascular risks.
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April, 2002:
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FDA changes Vioxx label to say the drug may protect against ulcers, but increase heart risks.
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October, 2003:
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Merck-funded study finds patients taking Vioxx are at a 39% increased risk of heart attack within the first 90 days, compared with Celebrex.
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August, 2004:
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HMO Kaiser Permanente reconsiders Vioxx for its member patients after an FDA study finds that patients who had taken more than 25 mg a day were 3.15 times as likely to have a heart problem.
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September, 2004:
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FDA approves Vioxx to treat juvenile rheumatoid arthritis.
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September 30, 2004:
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Merck announces a voluntary world-wide withdrawal of Vioxx.
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If you or a loved one has been hospitalized for a heart attack or stroke while taking Vioxx, or if a member of your family experienced a sudden death while taking Vioxx and its side effects ,
Davis & Feder P.A. at 1-866-857-8500 for a free, initial consultation. We review cases anywhere in the country.
An experienced attorney will assist you in evaluating your claim.
VIOXX/CELEBREX/BEXTRA LINKS:
FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product.
Bextra Effects on Heart Patients
Side effects of Vioxx.
The double edge sword of COX-2 NSAIDS.
Bextra information provided by FDA.
Consumer information regarding Celebrex.
Briefing Document for the FDA Advisory Committee prior to withdrawal of Vioxx.
