FDA Asks Committee To Examine Cardiovascular Risks of ADHD Drugs
FDA has asked the agency Drug Safety and Risk Management advisory committee to examine the potential cardiovascular risks of attention deficit hyperactivity disorder medications in response to reports of deaths and other serious adverse events in individuals who have taken the treatments, the AP/Rochester Democrat and Chronicle reports.
According to FDA, the agency has received reports of sudden deaths, heart attacks, strokes and hypertension in adults and children who have taken ADHD medications. FDA considers the reports "rare though serious," agency spokesperson Susan Bro said on Wednesday.
The advisory committee plans to meet on Feb. 9 and Feb. 10 to discuss proposals to further study the cardiovascular risks of ADHD medications, among other issues. The few previous longer-term studies of ADHD medications have not examined the cardiovascular risks of the treatments.
Arthur Levin, the consumer representative for the advisory committee, said, "The issue of drug treatment of attention deficit disorder in children has been a controversial one without this issue of cardiovascular risk too," adding, "It adds another concern to what will certainly be an interesting conversation."
According to a recent study conducted by pharmacy benefit manager Medco Health Solutions, sales of ADHD medications have increased at a high rate in recent years.
Spending on ADHD medications increased from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a market research company that specializes on the pharmaceutical industry (AP/Rochester Democrat and Chronicle, 1/4).