FDA, AHRQ to Investigate the Cardiac Risk of ADHD Drugs

Two-year study to determine if anecdotal reports do have causal link to attention-deficit/hyperactivity disorder medications

THURSDAY, Sept. 20 (HealthDay News) -- The U.S. Food and Drug Administration and the Agency for Healthcare Research and Quality have launched a two-year study to examine the cardiovascular risks of prescription drugs used to treat attention-deficit/hyperactivity disorder (ADHD).

Such drugs are prescribed to about 500,000 children and adults in the United States.

Vanderbilt University researchers will coordinate a retrospective analysis of an FDA-sponsored study of people who took ADHD medications between 1998-2005. They will examine data collected from inpatient, outpatient and outcomes databases of large health care organizations.

"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," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

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