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ARTICLE | Clinical News

Adderall and Adderall XR amphetamine neurology data

December 19, 2011 8:00 AM UTC

Researchers at Kaiser Permanente and colleagues reported data from a pair of retrospective cohort studies in a total of 443,198 adults aged 25-64 years from 4 healthcare claims databases showing that there was no evidence of an increased risk of serious cardiovascular events, including myocardial infarction (MI), sudden cardiovascular death or stroke, for current users of ADHD medications compared to non-users. Specifically, the adjusted rate ratio of serious cardiovascular events for current users vs. non-users of ADHD medications was 0.83. FDA said that although the rate was lower with ADHD drug use vs. non-use, the agency is not concluding that ADHD medications have a protective effect. Additionally, the adjusted rate ratios of MI, sudden cardiovascular death and stroke for current users vs. non-users were 0.88, 0.80 and 0.76, respectively. Data were published in the Journal of the American Medical Association.

The studies were the second and third of 3 studies sponsored by FDA and the Agency for Healthcare Research and Quality (AHRQ). The studies are part of a safety review initiated in 2007 evaluating ADHD drugs and the potential for increased risk of heart attack, stroke or other cardiovascular problems (see BioCentury, Oct. 1, 2007). Last month, researchers at Vanderbilt University and colleagues reported data from the first of the 3 studies showing that there was no evidence of an increased risk of serious cardiovascular events for current users of ADHD medications compared to non-users in a retrospective cohort study of 1,200,438 children and young adults aged 2-24 years (see BioCentury, Nov. 7). Based on the results, FDA updated a safety review and continues to recommend that healthcare professionals prescribe ADHD medications according to the professional prescribing label. ...