Rofecoxib (Vioxx) voluntarily withdrawn from market

Sibbald, Barbara

doi:10.1503/cmaj.1041606

Cited by 119 publications

(70 citation statements)

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“…The preliminary results from these uncontrolled studies indicate that there is promising therapeutic activity with such combinations and little additional toxicity. The COX-2 inhibitor used in our study, rofecoxib, has recently been withdrawn from the market by the manufacturer (45), in light of results obtained from the adenomatous polyp prevention on Vioxx trial (a colon polyposis prevention trial), indicating an increased risk for cardiovascular events in patients receiving this drug for >18 months. It should be noted that there were no cardiovascular events seen in patients who participated in the current study.…”

Section: Discussionmentioning

confidence: 99%

Phase II Clinical Trial Results Involving Treatment with Low-Dose Daily Oral Cyclophosphamide, Weekly Vinblastine, and Rofecoxib in Patients with Advanced Solid Tumors

Young

Whissell

Noble

et al. 2006

Clinical Cancer Research

102

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Purpose: Preclinical studies indicate that conventional chemotherapeutic agents given continuously at low doses (metronomic chemotherapy) may provide an improved therapeutic index. Cyclophosphamide and vinblastine have been best studied in experimental models, where tumor growth inhibition is achieved, at least in part, through antiangiogenic mechanisms. Experimental Design: Fifty patients with advanced solid tumors were enrolled in this phase II trial, 43 of whom had received at least one prior chemotherapy regimen. Patients were required to have Eastern Cooperative Oncology Group performance status of V2, a life expectancy of >3 months, and at least one measurable lesion. All patients received oral cyclophosphamide (50 mg) and rofecoxib (25 mg) daily in addition to weekly injections of vinblastine (3 mg/m 2

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Section: Discussionmentioning

confidence: 99%

Phase II Clinical Trial Results Involving Treatment with Low-Dose Daily Oral Cyclophosphamide, Weekly Vinblastine, and Rofecoxib in Patients with Advanced Solid Tumors

Young

Whissell

Noble

et al. 2006

Clinical Cancer Research

102

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“…The positive examples are patients who share an ADE-related diagnosis code 3 , i.e., have experienced a druginduced disorder. The ADE-related diagnoses were selected on the basis of having been classified as indicating ADEs by Stausberg et al [23], where category A.1 4 and category A.2 5 were considered in this study, as they were deemed to be the clearest indicators of ADEs. Among all of the diagnosis codes in A.1 and A.2, the 27 most frequent ones in the Stockholm EPR Corpus were chosen, where the least frequent code was assigned to 25 distinct patients.…”

Section: A Data Sourcementioning

confidence: 99%

“…As a result, not all severe ADEs caused by a drug can be discovered prior to its launch. There are many cases of drugs being withdrawn from the market, such as Vioxx for its doubled risk of causing myocardial infarction [5] and Cerivastatin for causing fatal rhabdomyolysis [6]. Post-marketing surveillance, also known as pharmacovigilance, primarily relies on collecting information from the users of the target drugs in order to inform decisions about their continued use in the treatment of patients.…”

Section: Introductionmentioning

confidence: 99%

Detecting adverse drug events with multiple representations of clinical measurements

Zhao

Henriksson

Asker

et al. 2014

2014 IEEE International Conference on Bioinformatics and Biomedicine (BIBM)

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Adverse drug events (ADEs) are grossly underreported in electronic health records (EHRs). This could be mitigated by methods that are able to detect ADEs in EHRs, thereby allowing for missing ADE-specific diagnosis codes to be identified and added. A crucial aspect of constructing such systems is to find proper representations of the data in order to allow the predictive modeling to be as accurate as possible. One category of EHR data that can be used as indicators of ADEs are clinical measurements. However, using clinical measurements as features is not unproblematic due to the high rate of missing values and they can be repeated a variable number of times in each patient health record. In this study, five basic representations of clinical measurements are proposed and evaluated to handle these two problems. An empirical investigation using random forest on 27 datasets from a real EHR database with different ADE targets is presented, demonstrating that the predictive performance, in terms of accuracy and area under ROC curve, is higher when representing clinical measurements crudely as whether they were taken or how many times they were taken by a patient. Furthermore, a sixth alternative, combining all five basic representations, significantly outperforms using any of the basic representation except for one. A subsequent analysis of variable importance is also conducted with this fused feature set, showing that when clinical measurements have a high missing rate, the number of times they were taken by one patient is ranked as more informative than looking at their actual values. The observation from random forest is also confirmed empirically using other commonly employed classifiers. This study demonstrates that the way in which clinical measurements from EHRs are presented has a high impact for ADE detection, and that using multiple representations outperforms using a basic representation.

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“…A number of drugs that have made it to the Canadian market have later been recalled. For example, rofecoxib (Vioxx), a COX-2 inhibitor, was shown to increase the risk of cardiovascular events despite no evidence of this risk during the initial clinical trial stage (Sibbald 2004). The addictive qualities of codeine have led to gastrointestinal problems because codeine is frequently sold in combination with nonsteroidal anti-inflammatory drugs (MacKinnon 2016).…”

Section: The Pharmaceutical Industrymentioning

confidence: 99%

A suggestion for evolution of Canada’s health regulatory system

White

Reid

2018

FACETS

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Aspects of Canada's health regulatory system are currently being reviewed. This is timely, as the regulation and definition of drugs, foods, and natural health products (NHPs) is in need of revision to facilitate greater transparency and less ambiguity. A number of studies have illustrated the importance of a nutritious diet to prevent and manage chronic disease. Therefore, legislation surrounding food health claims needs to be adjusted so that it is more informative for disease prevention and, in some cases, treatment. Canada is modernizing the regulation of self-care products, under which NHPs, including probiotic products, are listed. With the growing appreciation for the role that microbes play in human health and the recognition that many foods, including those containing probiotic organisms, can prevent or mitigate disease, this provides an opportunity to reassess regulatory categories.

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Rofecoxib (Vioxx) voluntarily withdrawn from market

Cited by 119 publications

References 0 publications

Phase II Clinical Trial Results Involving Treatment with Low-Dose Daily Oral Cyclophosphamide, Weekly Vinblastine, and Rofecoxib in Patients with Advanced Solid Tumors

Phase II Clinical Trial Results Involving Treatment with Low-Dose Daily Oral Cyclophosphamide, Weekly Vinblastine, and Rofecoxib in Patients with Advanced Solid Tumors

Detecting adverse drug events with multiple representations of clinical measurements

A suggestion for evolution of Canada’s health regulatory system

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