Continued alarm over ADHD drug safety

May 1, 2006

In February, the Advisory Committee on Drug Safety and Risk Management recommended, by a one-vote margin, that the FDA include a black box warning of cardiac risk on all sympathomimetic drugs used to treat ADHD in adults. As reported here in the March issue, the FDA was "considering" the recommendation. At the same time, FDA scientists analyzing data on adverse psychiatric events experienced by children taking ADHD drugs such as Ritalin, Concerta, and Adderall-including hallucinations featuring crawling insects, snakes, and worms as well as instances of aggression and suicidal ideation-had begun to think that situation, too, was sufficiently alarming to warrant a similar warning.

In February, the Advisory Committee on Drug Safety and Risk Management recommended, by a one-vote margin, that the FDA include a black box warning of cardiac risk on all sympathomimetic drugs used to treat ADHD in adults. As reported here in the March issue, the FDA was "considering" the recommendation. At the same time, FDA scientists analyzing data on adverse psychiatric events experienced by children taking ADHD drugs such as Ritalin, Concerta, and Adderall-including hallucinations featuring crawling insects, snakes, and worms as well as instances of aggression and suicidal ideation-had begun to think that situation, too, was sufficiently alarming to warrant a similar warning.

That's how things stood when a different advisory committee, the Committee on Pediatric Drugs, met to consider the issue. This time the outcome was different: No black box was indicated, the pediatric specialists concluded. Instead, the potential for both psychiatric and cardiac risks should be included in the warning section of the label, and a medication guide should be included describing the potential psychiatric and cardiovascular risks posed by the drugs.

In further actions on an ADHD drug, the Psychopharmacologic Drugs Advisory Committee voted that, because of a possible association with serious skin reactions, further safety data was needed before modafinil (Sparlon) could be approved for pediatric use. All this heightened scrutiny of drugs used to treat ADHD comes some 50 years after Ritalin was first introduced for this use-at a time when diagnoses of both childhood and adult ADHD are increasingly common, and pharmaceutical manufacturers are scrambling for approval of new, patent-protected drugs to enter this market.