Although steroids are considered safe for brief use to reduce inflammation, when taken for longer periods they can cause serious side effects like weight gain, fluid retention often visible in the face, sudden mood swings, muscle weakness, blurry vision, increased body hair, osteoporosis (bone weakening), high blood pressure, stomach irritation, and/or glaucoma. Consequently, NSAIDs are used to reduce inflammation if steroids can be avoided.

Vioxx works by preventing the formation of "inflammatory" prostaglandins. These compounds are produced by the enzyme "cyclooxygenase 2," commonly referred to as "Cox-2," and are believed to cause pain and inflammation, as well as prevent blood cells from sticking together. Vioxx is part of a group of drugs known as "Cox-2 inhibitors."

Unlike other NSAIDs, Vioxx does not also block a second enzyme, commonly called "Cox-1," that monitors and maintains stomach tissue. Since this protects the stomach lining, Vioxx has been promoted as being able to reduce pain and inflammation without also causing ulcers and gastrointestinal bleeding.

In November 2000, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study was published in the New England Journal of Medicine. The study compared approximately 4000 patients on 50 mg. of Vioxx per day (twice the highest approved dose) to approximately 4000 patients on the standard dose of Naprosyn (naproxen), an older NSAID. VIGOR was a one-year, "double-blind" study, meaning that neither the patients nor the investigators knew who was getting which treatment. "Double-blind" is considered the most impartial type of study. According to study results, Vioxx had a much lower incidence of digestive tract punctures, bleeding and/or blockages than naproxen.

However, another finding in the VIGOR study was that there was a higher incidence of cardiovascular problems in the Vioxx group than the naproxen group. The report concluded that the relationship between cardiovascular distress and the use of Vioxx was still unknown. This outcome surprised many heart experts, who then wanted more research done to assess the cardiac risk Vioxx posed.

Nonetheless, after reviewing the results of that study, the FDA agreed with the 2001 Arthritis Advisory Committee that the label for Vioxx should simply include information about possible cardiovascular complications. Also, it ruled that the warning about the risks of ulcers and gastrointestinal bleeding found on all NSAIDs should be modified, but not removed, from the label. Finally, in addition, the new label was to present comparison results showing that Vioxx was related to more incidences of high blood pressure than naproxen in studies of patients with rheumatoid arthritis.

Nonetheless, health concerns continued to arise regarding Vioxx. In June 2001, an article published in the medical journal The Lancet, reported on a woman who suffered kidney failure after taking Vioxx. While reversible, this incident raised questions about Vioxx's effect on kidney cells.

In August 2001, Vioxx was linked in a study by researchers from The Cleveland Clinic to an increase in the risk of blood clots, heart attacks and strokes. Their study was published in the Journal of the American Medical Association and was based on a review and analysis of previous clinical trials.

Additional study results and articles continued to appear in medical journals, further supporting suspicions about Vioxx's effect on the heart. In September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke.

After it reviewed all of its Vioxx studies, Merck claimed there was no evidence that, in comparison with other NSAIDs, the drug increased the risk of heart problems. The company argued that Vioxx only appeared to increase the risk of a heart attack in the study because Naproxen thins the blood much like aspirin does, thus reducing heart attack risk. Merck maintains that Vioxx's effect on the heart is minimal.

Meanwhile, because Vioxx and Pharmacia's drug Celebrex are so similar chemically, both Merck and Pharmacia had tried to promote their drugs by emphasizing subtle differences between them. The FDA discovered that Merck was suggesting in promotional audio conferences that Vioxx and other Cox-2 inhibitors were safer than older NSAIDs. Also, Merck sales representatives were promoting Vioxx for unproven uses like cancer, Alzheimer's disease and gout. Although both Celebrex and Vioxx are being studied for such applications, these claims have not yet been proven.

Upset that Merck was minimizing the potential safety risks of Vioxx and promoting it for unapproved uses, the FDA sent Merck a "Warning Letter" dated September 17, 2001. The letter demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses. It also required Merck to send letters about the deception to the medical community.

In April 2002, the FDA announced that it had added rheumatoid arthritis to the list of approved uses for Vioxx. It also presented the new labeling and warnings for Vioxx, based on the results of the VIGOR study.

Available patient information about Vioxx, derived from FDA-approved labeling, states that it can cause discomfort and may cause gastrointestinal bleeding, despite studies to the contrary. The labeling does acknowledge that while very rare, gastrointestinal bleeding may result in hospitalization and even death. Also, since serious ulceration and bleeding can develop with little or no symptoms, patients should be especially alert for anything that indicates gastrointestinal problems, and should seek medical treatment immediately.

In addition, patients should promptly report skin rash, unexplained weight gain, or excessive fluid and swelling in the body's tissues, called "edema," to their physicians. Patients should also be wary of any warning signs of liver damage such as nausea, fatigue, unexplained itching, jaundice, tenderness in the body's upper right side, and flu-like symptoms. In late pregnancy, Vioxx should be avoided because it may cause problems with a baby's blood circulation.

Merck & Co. voluntarily ceased worldwide Vioxx sales on September 30, 2004, citing risks of heart attack and stroke.

While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a product liability theory. Drug manufacturers can also be held liable for injuries to consumers based on theories of negligence, or even intentional or malicious conduct.

If you have taken Vioxx and experienced any unusual side effects, you should contact your physician at once. In addition, you should contact an attorney experienced in product liability litigation to discuss potential legal claims you might have, which could allow you to recover for the harm Vioxx has caused you.

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