What is Vioxx?

Vioxx (rofecoxib) is a member of the class of drugs known as nonsteroidal, anti- inflammatory drugs (NSAIDs). Other examples of NSAIDs include ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen. Traditional NSAIDs inhibit the production of a particular enzyme within the body called cyclooxygenase. Vioxx is a member of the class of NSAIDs known as “selective” NSAIDs because it inhibits the production of a particular form of cyclooxygenase called cyclooxygenase-2 (COX-2). Inhibiting the production of COX-2 by the body in turn blocks the body’s production of prostaglandins, which are chemicals believed to be associated with the pain and inflammation of injuries and immune reactions.

What is Vioxx used for?

Vioxx is used to relieve signs and symptoms of osteoarthritis, acute pain in adults, and painful menstrual cycles. COX-2 inhibiting NSAIDs such as Vioxx are considered to be easier on the stomach and better tolerated than other types of NSAIDs as Vioxx does not inhibit the activity of an enzyme called cyclooxygenase-1 (COX-1), which is involved in the production of prostaglandins which protect the stomach against ulcers.

What company makes Vioxx?

Merck & Co., Inc., manufactures Vioxx.

When did Vioxx first come on the market?

Vioxx won Food and Drug Administration (FDA) approval on May 21, 1999.

What is the problem with Vioxx?

Vioxx has recently been linked to an increased risk of heart attack and sudden cardiac death (an electrical disturbance of the heart that is not considered a heart attack). A recent FDA-funded study which reviewed the records of one of the biggest HMO’s in the United States concluded that patients taking Vioxx had a 50 percent greater chance of heart attacks and sudden cardiac death than those individuals taking a rival pain-relieving medication. Another major finding of the study was that patients taking the starting dose of Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death than those individuals taking any dosage level of the rival drug. Merck has argued in response that this type of study has inherent limitations and can produce inaccurate results.

Vioxx has also been linked to increases in blood pressure.

According to the FDA consumer information sheet on Vioxx, serious problems from stomach ulcers, such as bleeding, are well-known complications in people taking NSAIDs. The FDA information sheet notes that similar problems have occurred in people taking Vioxx, but very rarely. According to the FDA, the likelihood of stomach problems increases the longer drugs such as Vioxx are taken. However, the FDA states that even short-term treatment with Vioxx is not without risk. The FDA states that stomach problems associated with drugs such as Vioxx can result in symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting.

The FDA information sheet on Vioxx also states that serious problems such as liver damage have occurred in people taking NSAIDs. The information sheet also states that Vioxx can cause your body to retain fluids and swell.

When did problems with Vioxx begin surfacing?

Prior to the launch of Vioxx in 1999, Merck conducted a trial of Vioxx in which arthritis patients taking Vioxx were compared with another group of arthritis patients taking an older pain relieving medicine called naproxen. In that trial, over twice as many patients taking Vioxx had heart attacks and strokes compared with those arthritis patients who took naproxen. At the time, Merck argued that Vioxx had not caused the heart attacks, but instead, that naproxen had somehow prevented the heart attacks in patients taking that drug.

In April of 2002, in response to a study which found a higher cumulative rate of serious cardiovascular thromboembolic adverse events such as heart attacks, angina pectoris, and peripheral vascular events in a group of people taking Vioxx in comparison with another group of people taking another drug, the FDA approved new labeling information for Vioxx advising doctors to use caution in

prescribing Vioxx for patients with ischemic heart disease and noting that Vioxx in the 50 milligram dose should not be used chronically.

Available Dosages

Vioxx is available in 12.5 mg or 25 mg tablets. A 50 mg tablet is also available for acute pain, but is not to be taken for more than five days. Vioxx is also available in suspension form at 12.5 mg/5 ml or 25 mg/5 ml.

Glossary of Terms

Angina Pectoris - An oppressive pain or pressure in the chest caused by inadequate blood flow and oxygenation to heart muscle.

Inflammation - An immunological defense against injury, infection, or allergy, which is marked by increase in regional blood flow, immigration of white blood cells, and release of chemical toxins.

Ischemic heart disease - Refers to heart problems caused by narrowed coronary arteries. When arteries are narrowed, less blood and oxygen reach the heart muscle.

NSAIDs - Non-steroidal, anti-inflammatory drugs. A family of pain-relieving and inflammation-reducing drugs which operate by blocking prostaglandins, which are hormone-like substances in the body which contribute to pain, inflammation, fever, and muscle cramps.

Osteoarthritis - A type of arthritis marked by progressive cartilage deterioration in certain types of joints and in the vertebrae.

Peripheral vascular - Relating to the arteries and veins outside of the heart and brain.

Steroids - General term referring to a large group of hormones produced by the body. Steroids perform a wide variety of functions within the body. Some steroids produced by the body are involved in the regulation of inflammation.

Thromboembolic - Relating to the blocking of a blood vessel by a blood clot.

Relevant Articles

“Relationship Between Cox-2 Specific Inhibitors and Hypertension.” Daniel H. Solomon, Sebastian Schneeweiss, Raisa Levin, and Jerry Avorn. Hypertension, August 2004, page 140.

This article described a study conducted by the authors which found that Vioxx was associated with an increased risk of new onset hypertension requiring treatment in comparison with another drug called celecoxib, nonspecific NSAIDs, and no NSAID. The authors stated that the relative risk appeared to be increased for patients taking Vioxx who also had renal disease, liver disease, or congestive heart failure. The authors stated that although their study could not prove a causal relationship between taking Vioxx and new onset hypertension requiring treatment, the study did add significant new information about the risk of hypertension requiring treatment for patients taking Vioxx.

“COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease.” Wayne A. Ray, C. Michael Stein, James R. Daugherty, Kathi Hall, Patrick G. Arbogast, and Marie R. Griffin The Lancet, October 5, 2002, Vol. 360, p. 1071.

The authors concluded that their data, in conjunction with pre-marketing data gathered on Vioxx, raised serious doubts about the cardiovascular safety of Vioxx at doses greater than 25 mg. The authors recommended that long-term use of high-dosage Vioxx be avoided.

“Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors.” Debabrata Mukherjee, M.D., Steven E. Nissen, M.D., and Eric J. Topol, M.D. Journal of the American Medical Association, August 22/29, 2001–Vol. 286, No. 8, p. 954.

The authors of this article reviewed studies which had been conducted on Vioxx and stated that their review suggested a potential increase in cardiovascular event rates for the presently available COX-2 inhibitors. The authors stated that definitive evidence of such an adverse effect would require a prospective, randomized clinical trial. The authors concluded that given the popularity of the COX-2 inhibitors, it was mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of COX-2 inhibitors. Until such a trial was conducted, the authors urged caution in prescribing COX-2 inhibitors to patients at risk for cardiovascular morbidity.

“Prostaglandins: Modulators of Inflammation and Cardiovascular Risk.” Garret A. FitzGerald, M.D. JCR: Journal of Clinical Rheumatology, Vol. 10, No. 3, June Supplement 2004, p. S12.

The author of this article stated that while COX-2 specific drugs such as Vioxx had been shown to be effective in reducing gastrointestinal effects when compared with traditional NSAIDs, COX-derived prostaglandins also have complex interactions with the cardiovascular system. The author stated that the role of COX-2 in cardiac development and function is poorly understood at the present time.

The law firm of Dyer, Garofalo, Mann & Schultz shall not be held liable for any errors, omissions or inaccurate information contained in this educational booklet, or for any actions taken in reliance thereon. These materials have been compiled, reviewed and corrected to the best of the author’s ability. They are presented for educational purposes only. The author hereby declares that this writing is made without any statement or declaration which would represent that he/she is a doctor, licensed medical professional, or other type of medical counselor. Any questions regarding a medical diagnosis, referral, drug availability or pricing should be directed to either a licensed physician or to the product’s manufacturer. “Vioxx” is a registered trademark of Merck & Co., Inc. The materials presented here are done so under the benefit and authority of the First Amendment to the Constitution of the United States of America and said authority pertains to that Freedom of Speech and Freedom of the Press, ordained and preserved to the benefit of all peoples.

If you or a family member have suffered serious side effects or a fatal injury after ingesting a dangerous prescription drug (including Bextra, Celebrex, or Vioxx, you or the family member may be eligible to file a claim against the manufacturer. Call our team of professional attorneys at Dyer, Garofalo, Mann & Schultz for a FREE consultation, or complete our online form..