Dr. Shahal Rozenblatt, Clinical Neuropsychologist, New York

WSJ – Children shouldn’t stop taking drugs that treat attention deficit hyperactivity disorder

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The Food and Drug Administration on Monday said children shouldn’t stop taking drugs that treat attention deficit hyperactivity disorder, or ADHD, despite a study showing the stimulants may be associated with sudden death.

A study released in the American Journal of Psychiatry found an association between the stimulants, which include drugs such as Ritalin, and sudden death in children who take the medicines.

The FDA, which partly funded the study, said there isn’t enough evidence to conclude the drugs are dangerous and recommends people continue taking their medications. The study compared 564 healthy children who died suddenly to 564 who died in a motor-vehicle accident. The study found that two patients in the motor-vehicle group were taking stimulants, while 10 in the group of those who died suddenly were taking the medicines. The children died between 1985 and 1996, before certain stimulants, such as Adderall, became more commonly used.

“Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children,” FDA said.

One of the major limitations of the study, said FDA’s Robert Temple, was that so few children who were studied were on stimulants.

These stimulants are aimed at helping kids and adults concentrate. Some leading ADHD drugs include Shire Pharmaceuticals Group PLC’s Adderall, Johnson & Johnson’s Concerta, Eli Lilly & Co.’s Strattera and Novartis AG’s Ritalin.

Dr. Temple said the FDA has had its eye on whether ADHD medications cause heart problems and sudden death for years.

In 2006, the FDA required makers of ADHD drugs to update the drugs’ labels to warn of rare but increased risks for psychiatric problems, heart attacks and strokes.

The FDA is conducting two more studies to determine the relation of ADHD medicines to death and stroke. One involves children and should be completed in the fall, while the other, in adults, likely won’t be released until 2010.