This study was published in the New England Journal of Medicine on Novemand can be viewed here. FDA is also releasing the Statistical Review of the Final Report for Observational Study: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth and Addendum: Statistical Review of the Final Report for Observational Study: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth. The final study report is being released today: Final Report: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth. FDA will communicate the results of the other two studies (performed in adults) when our review of the study results is complete. These studies were designed to evaluate the potential increased risk of heart attack, stroke or sudden cardiac death that could be associated with the use of ADHD medications. This is the first of three separate but related studies that were sponsored by the FDA and the Agency for Healthcare Research and Quality (AHRQ). The possibility of a small to modest increase in risk cannot be ruled out because of the small number of serious cardiovascular events observed in the patients studied. ![]() Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications. Person-years is the total sum of the years that each person in a study has been under observation (for a description of the study analysis see the study report or article). This cohort study, conducted with 1,200,438 children and young adults (aged 2-24 years) and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs, only found 7 serious cardiovascular events in current users. Patients should continue to use their medicine for the treatment of ADHD as prescribed by their healthcare professional. ![]() Patients treated with ADHD medications should be periodically monitored for changes in heart rate or blood pressure.Stimulant products and atomoxetine should generally not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic. ![]() Healthcare professionals should take special note that: FDA continues to recommend that healthcare professionals prescribe these medications according to the professional prescribing label. This study did not find an association between use of ADHD medications and cardiovascular events. The medications studied include stimulants (amphetamine products and methylphenidate), atomoxetine, and pemoline (no longer marketed). amphetamine, mixed salts (Adderall, Adderall XR). ![]()
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