New Drug Promises to Help Kids with ADHD
Nov. 9, 2001 -- Millions of children in the U.S. take stimulant-based medications like Ritalin to control symptoms of attention deficit hyperactivity disorder (ADHD). The drugs work well, but parents are often uneasy about putting their kids on them. There may soon be another choice, however, if the FDA approves the first non-stimulant treatment specifically targeting the problem.
Newly published studies conducted by manufacturer Eli Lilly and Company (a WebMD sponsor) suggest the drug atomoxetine is both safe and effective in the treatment of children and adolescents with ADHD. The drug not only reduces symptoms associated with the disorder, but children on the drug function better in social and family situations. The manufacturer hopes atomoxetine will gain FDA approval by the latter half of next year.
"What is most exciting is that this drug not only does everything that we would want an ADHD medication to do, but it also has a broad range of impact on functioning that goes beyond treating symptoms traditionally linked to ADHD," Eli Lilly researcher Calvin R. Sumner, MD, tells WebMD.
It is estimated that 3% to 5% of school-age children in the U.S. have ADHD, and as many as 8 million have been prescribed Ritalin or Ritalin-based medications to treat its symptoms. New research suggests Ritalin works by helping to increase the levels of the brain chemical dopamine.
Atomoxetine appears to increase the levels of norepinephrine, another brain chemical believed to be important in regulating the pathways involved in paying attention and controlling impulses.
"Research in the past 20 years has consistently implicated dopamine and norepinephrine as being important chemical messengers in the brain related to the symptoms we see in attention deficit," says Sumner. "To date, the medications have targeted dopamine. We have not had an effective way of impacting norepinephrine."
Researchers conducted an eight-week study of the drug at 13 outpatient treatment sites across the U.S. Approximately 300 children and adolescents with ADHD received either atomoxetine or a placebo. '
Children who took the drug had significantly fewer ADHD symptoms and better social and family functioning than those who did not receive the medication. Side effects were minimal, and 83% of children completed the full eight weeks of treatment.
The findings are published in the Nov. 5 issue of Pediatrics.
Pediatric behavioral specialist Daniel Coury, MD, says atomoxetine may prove to be a good choice for children who experience unacceptable side effects on Ritalin. Tic disorders -- uncontrollable muscle movements especially in the face -- have been reported as one such side effect. Since the new drug works through different chemical pathways, Coury says, tics should not be a problem.
"This drug may also be more acceptable to parents, because it is a nonstimulant medication," Coury tells WebMD. "While doctors know these [stimulant] drugs to be effective and safe when prescribed properly, much of the public is very leery of them."
So leery, in fact, that the controversy continues to grow over whether ADHD drugs are being over-used. One study found that the drugs are prescribed five times as often today as they were just a decade ago.
Coury says the evidence is overwhelming that children with ADHD need to be on medication. But he adds that many children and adolescents are being placed on the drugs when they should not be, because of misdiagnosis.
"Many children who don't have ADHD and who might benefit from other treatments are immediately being placed on medication," he says. "When you have an accurate diagnosis there is no question that medication plus behavioral intervention is the best treatment."