An advisory committee of the FDA has recommended that a black box warning, the strongest possible warning, be placed on labels of drugs used to treat attention-deficient hyperactivity disorder (ADHD). Methylphenidate (sold under brand names including Ritalin, Concerta, Methylin, and Metadate) and other drugs are commonly used to treat ADHD.
The advisory committee decided to act on the safety of ADHD drugs based on reports of 25 deaths, 19 of them children, and several dozen other serious medical problems among people taking these drugs.
The drugs have been linked to heart attacks and strokes, along with other serious cardiovascular disorders like high blood pressure and disturbances in heart rhythm. They may also contribute to an increased risk of sudden cardiac deaths among children.
Although ADHD is generally thought of as a childhood disorder, about half of those with childhood ADHD continue to have symptoms of the disorder and take these drugs as adults. Symptoms in adults include poor concentration, easy distractibility, impulsive behavior, and heightened motor activity.
Despite the apparent effectiveness of these drugs in controlling the symptoms of ADHD, there has long been concern that they are being overused. According to one estimate, nearly 4 million children and adults are taking drugs to overcome the lack of concentration associated with ADHD, and the number of prescriptions for adults is on the rise.
Before making any decision about whether you or your child should discontinue taking these drugs, it's important to note that this issue is still being debated. The FDA advisory committee unanimously recommended that a medication guide warning of the increased cardiovascular risk be given to patients and their children.
But the same committee was split eight to seven (with one abstention) on the addition of the black box warning on the label. There is also considerable disagreement among those who treat patients with ADHD about the risks of these drugs compared with their apparent benefits. As one member of the committee stated, more data and information are needed from further studies.
