ADHD Drug MedGuides Show FDA’s Focus On Consumer Risk Communications
Executive Summary
FDA's requirement that manufacturers of attention deficit/hyperactivity drugs develop patient medication guides illustrates the growing importance to the agency of communicating risks to the public
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ADHD MedGuide for parents
A medication guide directed at parents providing information about attention deficit/hyperactivity disorder can now be accessed through the ParentsMedGuide.org online resource center, the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association announce Oct. 2. Organized around questions parents might have about ADHD, the guide provides information on symptoms, treatment options, types of medications, side effects, and co-occurring disorders. The initiative follows FDA's requirement that all manufacturers of ADHD drugs disseminate MedGuides to educate patients, care-givers and clinicians of the drugs' potential links to adverse cardiac and psychiatric events (1"The Pink Sheet" Feb. 26, 2007, p. 3)...
ADHD MedGuide for parents
A medication guide directed at parents providing information about attention deficit/hyperactivity disorder can now be accessed through the ParentsMedGuide.org online resource center, the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association announce Oct. 2. Organized around questions parents might have about ADHD, the guide provides information on symptoms, treatment options, types of medications, side effects, and co-occurring disorders. The initiative follows FDA's requirement that all manufacturers of ADHD drugs disseminate MedGuides to educate patients, care-givers and clinicians of the drugs' potential links to adverse cardiac and psychiatric events (1"The Pink Sheet" Feb. 26, 2007, p. 3)...
As Medication Guide Requirements Increase, FDA Considers Electronic Delivery
FDA is considering electronic distribution of Medication Guides as their use increases and questions are raised about whether they are consistently reaching patients