Expert opinion on drug safety
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Preliminary research results indicate that exposure to anesthetics affects health. ⋯ In the scientific literature reviewed, there is evidence of exposure to anesthetics, especially nitrous oxide and halogenated gases, being associated with general health and genotoxic risks, but conflicting results have been obtained. The result of this review further stresses the need for scientific knowledge in this area and enhances the studies, above all, on people exposed for long periods.
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The world of drug safety is undergoing major changes in the US, Europe and elsewhere following several major drug withdrawals, billion dollar lawsuits, NGO studies of drug safety and widespread media attention in the US. Some of the events of the past few years are reviewed along with some of the reactions and changes in the FDA and the field of drug safety followed by the author's conclusions and views on the future of drug safety.
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Nonsteroidal anti-inflammatory drugs (NSAIDs) play a crucial role in the treatment of ankylosing spondylitis (AS). Most of the AS patients require a continuous and long-term NSAIDs therapy; therefore the question of NSAIDs safety in this population becomes very important. ⋯ Four clinical trials were found: three randomized controlled trials (RCTs) and one open-label extension of a previous RCT. All RCTs showed a good safety profile for celecoxib treatment in AS, similar to that of nonselective NSAIDs. However, long-term (>or= 1 year) celecoxib safety in AS was not investigated in RCTs. Based on the results of long-term non-AS celecoxib studies, most of the AS patients (because of young age and fewer comorbidities) are probably at low risk for cardiovascular and gastrointestinal complications. Celecoxib showed a good efficacy and safety profile in AS, but further investigations are needed to clarify the long-term safety of celecoxib in this group of patients.