FDA issues warning about ADHD drugs

The US Food and Drug Administration (FDA) has directed manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to warn patients of the risk of possible cardiovascular and adverse psychiatric symptoms associated with the medicines.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," Dr Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said.

"In our ongoing commitment to strengthen drug safety, [the] FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labelling and in developing new patient medication guides to better inform doctors and patients about these concerns."

ADHD is a condition that affects approximately three to seven per cent of school-aged children and approximately four per cent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason or becoming manic, even in patients who did not have previous psychiatric problems.