Vioxx (Rofecoxib) - Summary

VIOXX SUMMARY

Note: VIOXX (rofecoxib) was removed from the US Market in September 2004.

VIOXX is indicated:

For relief of the signs and symptoms of osteoarthritis.

For relief of the signs and symptoms of rheumatoid arthritis in adults.

For the management of acute pain in adults.

For the treatment of primary dysmenorrhea.

For the acute treatment of migraine attacks with or without aura in adults.

The safety and effectiveness of VIOXX have not been established for cluster headache, which is present in an older, predominantly male, population.

See all Vioxx indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vioxx (Rofecoxib)

Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. [2010.10.20]
PURPOSE: Laboratory and case-control studies suggest a pivotal role for the cyclooxygenase-2 (COX-2) pathway in colorectal carcinogenesis. The purpose of this study was to test whether the COX-2 inhibitor rofecoxib could reduce recurrence and improve survival when administered in the adjuvant setting of colorectal cancer (CRC)... CONCLUSION: In this study of abbreviated therapy in the adjuvant setting of CRC, rofecoxib did not improve OS or protect from recurrence in unselected patients. In addition, COX-2 expression did not correlate with prognosis overall or predict effectiveness of COX-2 inhibitors.

Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. [2010]
colorectal cancer (CRC)... CONCLUSION: In this study of abbreviated therapy in the adjuvant setting of CRC,

Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. [2009.11.23]
BACKGROUND: In September 2004, rofecoxib was voluntarily withdrawn from the worldwide market. Our objective was to determine whether and when analysis of published and unpublished placebo-controlled trials could have revealed cardiovascular risk associated with rofecoxib before its withdrawal as an example to inform future postmarket pharmaceutical safety surveillance efforts... CONCLUSION: Cumulative pooled analysis of all randomized, placebo-controlled trials demonstrates a trend toward increased cardiovascular risk associated with rofecoxib compared with placebo as early as December 2000, the comparison reaching a P value of .05 by June 2001, nearly 3(1/2) years before the manufacturer's voluntary market withdrawal.

Evaluation and management of post-shock wave lithotripsy pain with third-generation lithotriptors using rofecoxib. [2009.03]
INTRODUCTION: Newer generation lithotriptors have been modified to induce less pain. We evaluated factors contributing to post-shock wave lithotripsy (SWL) pain and assessed potential benefits of preemptive analgesia using Rofecoxib, a COX-II inhibitor, and potential effects on stone passage rates... CONCLUSIONS: Pain after SWL is moderate to severe using third-generation lithotriptors and is significantly reduced by POD 3. Younger patients and those with significant pretreatment pain had more pain after treatment. Preemptive Rofecoxib reduced post-SWL pain, but had no impact on stone passage.

Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. [2008.11.15]
BACKGROUND: Selective inhibition of cyclo-oxygenase-2 has been associated with an increased risk of cardiovascular events in several clinical trials. The Adenomatous Polyp Prevention on Vioxx (APPROVe) study assessed the effect of 3-year treatment with a cyclo-oxygenase-2 inhibitor, rofecoxib (25 mg), on recurrence of neoplastic polyps of the large bowel. We report the cardiovascular outcomes of a long-term follow-up of participants in the trial... INTERPRETATION: Use of rofecoxib is associated with increased rates of APTC events. Study data are compatible with an early increase in risk that persists for one year after stopping treatment.

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Clinical Trials Related to Vioxx (Rofecoxib)

Study of Vioxx and Radiation Therapy for Brainstem Glioma [Terminated]
It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.

CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen [Completed]
Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and inflamation in these patients once interactions with coumadin are supposed to be lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and placebo.

A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee [Completed]
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee

Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201) [Completed]

Safety of Lumiracoxib in Patients With Osteoarthritis [Completed]
This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

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Reports of Suspected Vioxx (Rofecoxib) Side Effects

Nausea (14),  Anaemia (13),  Drug Ineffective (12),  Diarrhoea (12),  Depression (10),  Drug Hypersensitivity (10),  Osteomyelitis (9),  Somnolence (9),  Rheumatoid Arthritis (9),  Arthropathy (9), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Vioxx review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		possible arthritis
Dosage & duration:		Don't remember (dosage frequency: don't remember) for the period of 3 days
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Don't believe that I took it long enough to really tell if it was working. I had an allergic reaction shortly after I started taking it.
Side effects:		My upper lip swelled up an became rough an mildly itchy. It remained rough and swollen for a week. For another week it just felt "weird". There was some crustiness around my mouth. Hadn't eaten or taken anything else orally that was new to me.
Comments:		I don't remember the details, but I did follow the prescription directions to the letter. Did not take more than was prescribed to me and took it in the prescribed manner.