ADHD drugs send thousands to the ER

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In another letter in the journal, the heads of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry wrote they are concerned a black box warning would discourage use of ADHD drugs, raising patients' risks of academic failure, substance abuse and other problems.

Drug safety debated
This past February, an FDA drug safety advisory panel voted 8-7 for a black box warning. The next month, another FDA panel instead recommended data on cardiac and other risks go in a new "highlights" section the agency plans to add to the top of drug inserts.

Dr. Marsha Rappley, pediatrics professor at Michigan State University, and two other doctors on the advisory panels believe the vote for a black box was premature.

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She said studies show the drugs raise blood pressure and pulse rates a bit, but it's unknown whether that would harm children taking them for years, and that cardiac risks may be higher for adults.

Dr. Steven Nissen, cardiology chief at the Cleveland Clinic, who had pressed for a black box warning at the FDA panel meeting, said ADHD drugs are powerful stimulants and inherently risky. Nissen and other doctors say the drugs are being prescribed to some who don't need them.

This week, the FDA said it is "working diligently" on "labeling changes that we feel accurately reflect the available data and the advice of the committees." The agency declined interview requests.

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