Cardiovascular risks prompt advisory panel to call for a black-box warning for ADHD drugs

February 10, 2006

Gaithersburg, MD - In a move many considered surprising, a US Food and Drug Administration advisory panel voted yesterday for the inclusion of a black-box warning on drugs used for the treatment of attention-deficit hyperactivity disorder (ADHD). The advisory committee voted 8-7 to add the strongest possible warning to the label after reports of deaths and serious cardiovascular problems, including heart attacks and strokes, among patients taking the popular medications.

In a review prepared by the FDA for the advisory panel, agency medical officers described reports of 25 sudden deaths, including 19 children, among people taking the medications. Another 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, and arrhythmias, were also reported to the panel. One FDA analysis suggested the risk of sudden cardiac death in children prescribed the stimulants was 1.5 to 2.5 times greater than in the general population, according to various media reports.

"The data are only suggestive at this point, but because of the gravity of the side effect, namely sudden death, physicians need to be made clearly aware of that concern," said panel chair Dr Peter Gross (Hackensack University Medical Center, NJ).

The New York Times reported that nearly 4 million adults and children take drugs to combat ADHD, a disorder characterized by impulsivity and lack of concentration, but the FDA decision is only likely to intensify the contentious debate about whether the drugs are overused [1]. Drugs used to treat ADHD include methylphenidates such as Ritalin, Concerta, Methylin, and Metadate. Adderall and Adderall XR, amphetamines also used to treat ADHD, already carry a black-box warning about possible cardiovascular side effects. In yesterday's decision, the panel voted unanimously to recommend patient guides with the medications.

The FDA advisory panel had initially convened to determine how to research possible cardiovascular heath risks of the drugs and had not been asked to address labeling, according to Times reporter Gardiner Harris. However, with the drugs' popularity and the number of prescriptions for adults on the rise, panel members felt the FDA needed to study the drugs more carefully and to warn patients and doctors about the potential risks to the heart, writes Harris.


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