Find information on thousands of medical conditions and prescription drugs.

Vioxx

Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that was used in the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea. Formerly marketed by Merck & Co. under the trade names Vioxx, Ceoxx and Ceeoxx, it was voluntarily withdrawn from the market in 2004 because of concerns about increased risk of heart attack and stroke. more...

Home

Vagifem

Valcyte

Valine

Valium

Valstar

Valtrex

Vaniqa

Velcade

Velivet

Venlafaxine

Ventolin

Vepesid

Verapamil

Verelan

Vermox

Versed

Vfend

Viadur

Viagra

Vicoprofen

Vidarabine

Vidaza

Videx

Vioxx

Viread

Visine

Vistide

Visudyne

Vitaped

Vitrase

Vivelle

Volmax

Voltaren

Voriconazole

Vosol

Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. Worldwide, over two million people were prescribed Vioxx at the time. In the year before withdrawal, Merck had a sales revenue of US$2.5 billion from Vioxx.

Rofecoxib was available on prescription as tablets and as an oral suspension.

COX-2 selective inhibitor

Rofecoxib belongs to the group of NSAIDs known as COX-2 selective inhibitors or coxibs (CycloOXygenase-2 InhiBitors). Being COX-2 selective means that these drugs act specifically on one form of the cyclooxygenase (COX) enzyme, namely the COX-2, whereas previous NSAIDs inhibited both COX-1 and COX-2. This specificity allows rofecoxib and other COX-2 inhibitors to reduce inflammation and pain while minimizing undesired gastrointestinal adverse effects - peptic ulcers - that are common with non-selective NSAIDs such as aspirin, naproxen, and ibuprofen.

Interestingly, at the time of its withdrawal, rofecoxib was the only coxib with clinical evidence of its superior gastrointestinal adverse effect profile over conventional NSAIDs. This was largely based on the VIGOR (Vioxx GI Outcomes Research) study, which compared the efficacy and adverse effect profiles of rofecoxib and naproxen. (Bombardier et al., 2000).

Adverse drug reactions

Aside from the reduced incidence of gastric ulceration, rofecoxib exhibits a similar adverse effect profile to other NSAIDs.

Withdrawal from the market

VIGOR study

The VIGOR study, published in 2000, had indicated a significant 4-fold increased risk of acute myocardial infarction (heart attack) in rofecoxib patients when compared with naproxen patients (0.4% vs 0.1%, RR 0.25) over the 12 month span of the study. There was no significant difference in the mortality from cardiovascular events between the two groups. Nor was there any significant difference in the rate of myocardial infarction between the rofecoxib and naproxen treatment groups in patients without high cardiovascular risk. The difference in overall risk was accounted for by the patients meeting the criteria for low-dose aspirin prophylaxis of secondary cardiovascular events (previous myocardial infarction, angina, cerebrovascular accident, transient ischemic attack, or coronary bypass), but who were excluded from taking low-dose aspirin in the initial design study. Once this risk was noted, Merck notified investigators in other rofecoxib studies to modify allow high-risk patients to take low-dose aspirin. (Bombardier et al., 2000)

Merck's scientists interpreted the finding as a protective effect of naproxen in reducing the risk of MI in high cardiovascular risk patients by 80 percent (which some commentators have noted would make naproxen three times as effective as aspirin). The results of the VIGOR study were submitted to the United States Food and Drug Administration (FDA) in February 2001, which led to the introduction, in April 2002, of warnings on Vioxx labelling concerning the increased risk of cardiovascular events (heart attack and stroke).

Read more at Wikipedia.org

• [List your site here Free!]

Vioxx's runaway jury
From Weekly Standard, The, 10/3/05 by David R. Henderson

You'd think that a reputable company has at least the same chance of a fair trial as an accused murderer. But as the recent Angleton, Texas, jury's verdict against Vioxx shows, you'd be wrong.

The horrible effect of this verdict will be that people like you and me, who badly want medicines to help us with pain or even save our lives, will have fewer options. For instance, Merck's new COX-2 inhibitor, Arcoxia, is available only outside the United States.

Consider the flimsy evidence the Texas jury used to find against Vioxx. First, one clinical trial by Merck showed an elevated risk of heart attack in patients who took heavy doses of Vioxx for at least eighteen months. But Robert Ernst died after taking Vioxx for only eight months. Second, the coroner, Dr. Maria Araneta, found that Ernst died of arrhythmia, or irregular heartbeat, not of a heart attack. It's true that Araneta later reversed herself but in a speculative manner. She testified that it may have been an undetected blood clot that caused his death. Not only did the coroner fail to find the smoking gun, but also, to continue the analogy, she failed to find a bullet.

Consider the consequences for us. Many of us would be willing to sign in a heartbeat, so to speak, a contract with reputable drug companies giving up our right to sue in various circumstances in return for the right to buy promising new medicines. But because the courts are so "concerned" for us, they won't enforce such contracts. As a result, reputable companies such as Merck know that courts and juries will second-guess them and impose heavy penalties if the companies make decisions that we would gladly have them make but that juries might disagree with after the fact. The cases they subsequently lose could cost tens of billions of dollars.

Merck and other reputable drug companies are likely to respond in two ways to this threat from runaway juries. First, before releasing new drugs, companies will probably be even more cautious. According to the Tufts University Center for the Study of Drug Development, since the 1960s the total time required for drug development--from synthesis or discovery in the laboratory to delivery to the patient--increased from 8.1 years to 15.2 years. Expect another year or two on top of that. This means that some of us will die or live in pain while companies do studies on thousands of subjects to further reduce the probability that miracle drugs have low-probability side effects.

Second, pharmaceutical companies will develop only clear winners. Medicines that serve small markets or may have some awkward problems will be skipped. Good riddance? Not so fast. Like Vioxx, many of the drugs we rely on, including aspirin, can cause serious side effects. The medicines we will do without are ones that many of us would love to have.

Oh yes, there's another difference between Merck and an accused murderer. No one thinks the murderer was out to help the victim. Merck was.

David R. Henderson, formerly the senior economist for health policy on the President's Council of Economic Advisers, is a research fellow at the Hoover Institution and coauthor of Making Great Decisions in Business and Life.

Hoover Institution Stanford University Stanford, CA 94305-6010 Tel: 877.466.8374 Fax: 650.723.1687 info@hoover.stanford.edu www.hoover.org

Return to Vioxx

Home

Contact

Resources

Exchange Links

ebay