Furthermore, the safety profile of rofecoxib has not been rigorously assessed in patients with hemophilic arthropathy, and the application of risk evaluation and mitigation strategies REMS also needs to be considered. For example, limiting prescriptions to patients with low cardiac risk and regular cardiovascular screening would be expected to mitigate cardiovascular risk. Although studies have shown that the cardiovascular risk profile of rofecoxib may be worse than that of other NSAIDs , the magnitude of this risk is modest and the above strategies may provide mitigation.
For example, one large cohort study found that the odds ratios for acute myocardial infarction were 1. The modest difference in the point estimates of risk with the potential for additional mitigation strategies suggests that sufficient clinical equipoise exists to justify a clinical trial.
Development and appropriate prescribing of this medication are worthy of further study. The need for novel pain treatments for patients with hemophilic arthropathy is substantial.
Current pharmaceutical management of hemophilic arthropathy-related pain relies on long-term opioid use and intra-articular corticosteroid injections, both of which come with significant risks. In addition to the risk of addiction, studies have shown that an opioid supply of at least days over a 3.
The risk of myocardial infarction from long-term opioid therapy is comparable to that observed with rofecoxib, supporting the argument that sufficient equipoise exists to justify conducting a clinical trial. Intra-articular corticosteroid injections may also be associated with potentially serious complications, including bone loss and joint destruction, which led Kompel et al.
Concerns about off-label prescribing if rofecoxib were re-introduced into the market similarly may be over-stated. Some critics suggest that because drugs that treat common conditions, such as osteoarthritis pain in the case of rofecoxib, have high rates of off-label use, the risk of market reentry is particularly pronounced.
They also point to examples of nonadherence with REMS commonly utilized by the FDA to control the use of drugs with known safety risks. Following the study, Merck began longer-term trials of Vioxx.
Previous to the recall, the FDA called for changes on the labeling of Vioxx side effects to include information about the increased risk of cardiovascular events such as heart attack and stroke. Several of the recent studies and findings have prompted questions about the health risks and side effects of COX-2 inhibitors e.
Aleve, Naprosyn. Important new updates include the following:. Celebrex side effects : A study by the National Cancer Institute testing to see if Celebrex chemical name: celecoxib could help prevent colon cancer among patients who had already had colon polyps removed was halted in December Patients who took milligrams of Celebrex a day were found to have 2. Patients who took milligrams of Celebrex each day were found to have 3. See Potential Risks and Complications of Celecoxib.
However, a similar ongoing study comparing Celebrex milligrams once-a-day dose versus placebo for a similar period of time has not shown increased risk. Bextra side effects: A recent study by Pfizer Bextra's manufacturer of over 1, patients who had recently undergone cardiac surgery showed that those who took Bextra chemical name: valdecoxib for their pain had an increased risk of heart and blood clotting problems compared to those who did not take any drug.
The study added to the mounting safety questions surrounding Vioxx, and is expected to boost its biggest rival, Pfizer's Celebrex. CBS News Correspondent Sharyl Attkisson reports experts flagged a heart issue as far back as , when Merck's own pre-trial study of Vioxx revealed significantly more heart attacks and strokes than a competitor.
Deepak L Bhatt, a Cleveland Clinic cardiologist. David Graham, the lead FDA scientist on the government study, was so concerned, he told reporters: "I don't think doctors should prescribe high doses of Vioxx, and patients shouldn't take it.
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