The Food and Drug Administration (FDA) has advised manufacturers of all attention-deficit/hyperactivity disorder (ADHD) drugs to alert patients about possible cardiovascular or psychiatric risks associated with taking the drugs.
The agency has asked the manufacturers to develop medication guidelines that will be given to patients, families, or caregivers when ADHD drugs are dispensed, an action resulting from FDA reviews of these medications. One such review noted reports of sudden death in patients with underlying heart problems and of stroke and heart attack in adults with other cardiac risk factors. Another found a small increased risk—about 1 per 1000 patients—of drug-related psychiatric adverse events such as hearing voices, paranoia, and mania, even in patients with no history of psychiatric problems.
In May 2006, the FDA had required manufacturers to revise ADHD drug labeling for physicians to reflect these cardiac and psychiatric risks. Preliminary patient medication guides for each . . . [Full Text of this Article]
