Big News: On November 27, 2002, the US Food and Drug Administration (FDA) approved Strattera (atomoxetine HCL), a new non-stimulant medicine for ADHD. This is the first new type of drug to be approved for ADHD in almost 30 years. Unlike Ritalin, this drug will not be a controlled substance. Studies suggest that the abuse potential is lower, and that the new medicine does not cause sleep problems in children. It works by enhancing levels of the neurotransmitter norepinephrine (it is a selective norepinephrine reuptake inhibitor). I expect this drug will be a huge seller. Millions of children will probably receive this drug. Its manufacturers hope it will be the first line treatment for ADHD. Strattera may indeed prove to be gentler and more effective than its predecessors. Nevertheless, it is wise to keep in mind that to date, studies have only been done in a few thousand children, showing effectiveness for only 9 weeks, and safety for only 1 year.

We do know that the drug increases both heart rate and blood pressure in children.

We also know that in the short-term studies (less than 9 weeks) the children on Strattera lost weight, while their peers were gaining. In the longer studies, children on Strattera fell on both their weight and their height growth curves. No one knows whether or not there will be any effect on adult height -- or on the adult brain, or GI tract, or sexual organs, or any organ.

In children, the most common side effects are (occurring in at least one in twenty children and at at least twice the rate of those taking placebo): indigestion, nausea, vomiting, fatigue, decreased appetite, dizziness, and mood swings. Sometimes it is easier to uncover side effects in adults. In adult studies, the most common side effects are (occurring in at least one in twenty adults and at at least twice the rate of those taking placebo): constipation, dry mouth, nausea, decreased appetite, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, a variety of urination problems, and painful menstrual periods.

Studies show that the drug can impair sexual function in both men and women, and the manufacturers suggest that these studies underestimate the problem. I am wary about giving a medicine that affects sexual function to children whose sexual organs are still developing.

I am very glad that a new drug, and a new class of drug, is available. I am grateful for the brilliant thinking and the commitment to research and development that enabled its introduction. Strattera may prove to be a great benefit to many children. I greet its arrival with caution, however, until more is known.

Alan Greene MD FAAP

December 6, 2002

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