Expert opinion on drug safety
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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.
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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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At present, cephalosporins represent one of the most prescribed classes of antibiotics. Although allergic reactions have been estimated to be infrequent, the number of reactions to cephalosporins is increasing due to their wide use. Cross-reactivity with penicillins has mainly been evaluated in patients with penicillin allergy. ⋯ Unlike penicillins, cephalosporin haptens or determinants have not been defined, and therefore the diagnosis is complicated. Nevertheless, skin tests with cephalosporins are useful in the evaluation of several allergic reactions. Although more studies are necessary, a negative result in skin testing to penicillin and cephalosporins with different side chains seems to be a good predictor of tolerance, and could be used in select cases.
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Raloxifene is a benzothiophene, selective estrogen receptor modulator with estrogen-agonist effects in the skeleton and the cardiovascular system but estrogen-antagonist effects in the uterus and the mammary gland. This compound was first approved in different countries for the prevention and treatment of osteoporosis. ⋯ Different placebo-controlled trials indicated that raloxifene is effective in reducing invasive breast cancer risk in postmenopausal women. In a recent comparative study, a similar efficacy between raloxifene and tamoxifen for breast cancer prevention was demonstrated, but raloxifene showed a more favorable safety profile.