A large study of possible heart attack, stroke and other cardiovascular risks associated with drugs to treat attention deficit hyperactivity disorder (ADHD) was announced Monday by the U.S. Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ).
Researchers will analyze clinical data of about 500,000 children and adults who've taken ADHD medications, which can increase heart rate and blood pressure.
"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment. The goal of this study is to develop better information on this question," Dr. Gerald Dal Pan, director of FDA's Office of Surveillance and Epidemiology, said in a prepared statement.
The analysis of the data will take about two years to complete.
ADHD affects about three percent to five percent of school-age children and about four percent of adults, according to the U.S. National Institute of Mental Health. People taking or being considered for treatment with ADHD drugs should work with their doctor or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, the FDA and AHRQ recommend.