Arch Intern Med
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The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems. ⋯ The Food and Drug Administration's Adverse Event Reporting System is the primary surveillance database used for the identification of safety problems of marketed drugs. Despite the limitations of underreporting, differential reporting, and uneven quality, submitted reports often allow the identification of serious adverse events that are added to the product labeling information. In rare instances, additional regulations, up to and including market removal, have been required. We encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adverse drug reactions to manufacturers and the Food and Drug Administration.
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The current national measure set for the quality of health care underrepresents the spectrum of outpatient care and makes limited use of readily available national ambulatory care survey data. ⋯ Measurable quality deficits and modest improvements across time call for greater adherence to evidence-based medicine in US ambulatory settings. Although significant racial disparities have been described in a variety of settings, we observed that similar, although less than optimal, care is being provided on a per-visit basis regardless of patient racial/ethnic background.
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Restless legs syndrome (RLS), a common sensorimotor disorder, has a wide range of severity from merely annoying to affecting sleep and quality of life severely enough to warrant medical treatment. Previous epidemiological studies, however, have failed to determine the prevalence of those with clinically significant RLS symptoms and to examine the life effects and medical experiences of this group. ⋯ Clinically significant RLS is common (prevalence, 2.7%), is underdiagnosed, and significantly affects sleep and quality of life.
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Although depression is a well-documented risk factor for clinical heart disease, its association with subclinical atherosclerosis is unclear. We hypothesized that middle-aged women with a history of recurrent major depression would show evidence of atherosclerosis. ⋯ In this sample of asymptomatic middle-aged women without known coronary disease, recurrent major depression was independently associated with coronary and aortic calcification. Waist-hip ratio in part mediated the association. Our findings suggest that recurrent major depression may be a risk factor for early atherosclerosis in women.