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.

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NEWS HIGHLIGHTS

Media Articles Related to Vioxx (Rofecoxib)

Researchers confirm Vioxx doubled cardiovascular risks in cancer study
Source: The Doctors Lounge - Rheumatology
Vioxx found to double the risk of developing a cardiovascular "event" when compared to placebo.

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Published Studies Related to Vioxx (Rofecoxib)

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.

Negative effects of rofecoxib treatment on cardiac function after ischemia-reperfusion injury in APOE*3Leiden mice are prevented by combined treatment with thromboxane prostanoid-receptor antagonist S18886 (terutroban). [2008.08.01]
OBJECTIVE:: Selective COX-2 inhibition by rofecoxib was associated with increased risk of cardiovascular events. We hypothesized that concomitant treatment with thromboxane prostanoid receptor antagonist S18886 might ameliorate possible negative effects. We evaluated the effects of S18886, rofecoxib, and the interaction of both compounds in a combined treatment on myocardial infarct (MI) size and cardiac function after experimental ischemia/reperfusion injury in hyperlipidemic APOE*3Leiden transgenic mice... CONCLUSIONS:: Rofecoxib treatment reduced global and systolic LV function after ischemia-reperfusion injury in APOE*3Leiden mice. These negative effects are prevented by combined treatment with thromboxane prostanoid-receptor antagonist S18886 (terutroban).

Was the thrombotic risk of rofecoxib predictible from the French Pharmacovigilance Database before 30 September 2004? [2008.08]
OBJECTIVES: Rofecoxib was withdrawn from the market on 30 September 2004 following the results of a randomized controlled trial. Following this sudden decision, several controversies occurred in the literature to determine whether this adverse drug reaction (ADR) could have been detected earlier. The aim of this study was to investigate whether this kind of signal could have been seen using the French Pharmacovigilance Database before this date of rofecoxib withdrawal... CONCLUSION: Despite the compulsory limits of the case/noncase methodology, this study found an association between rofecoxib exposure and the occurrence of "serious" thrombotic ADRs as early as the end of the first year of rofecoxib marketing in France. The association between celecoxib and the occurrence of such ADRs appears less clear. Our work also shows the potential use of careful analysis of pharmacovigilance databases (investigating, for example, cumulative values of risk) in the early identification of new ADRs.

The effects of preoperative rofecoxib, metoclopramide, dexamethasone, and ondansetron on postoperative pain and nausea in patients undergoing elective laparoscopic cholecystectomy. [2007.10]
BACKGROUND: No trial to date has evaluated the combined effect of preoperative Rofecoxib, Metoclopramide, Dexamethasone, and Ondansetron on postoperative pain and nausea in patients undergoing laparoscopic cholecystectomy (LC)... CONCLUSIONS: The use of this preoperative regimen resulted in decreased LOS, maximum pain, and nausea ratings. Patients in the intervention group required less postoperative anti-emetics.

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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.

A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas [Completed]
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.

A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement. [Terminated]
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.

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

A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome [Terminated]

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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.