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As parents wait, doctors debate ADHD drugs

A surprise push for a black-box warning startles experts who say the pills are safe.

March 20, 2006|Shari Roan | Times Staff Writer

Methylphenidate has been in use for more than 50 years with good success, and its benefits have been noted in more than 200 studies, says Dr. Laurence Greenhill, a child psychiatrist and chairman of a committee appointed to study the issue by the American Academy of Child and Adolescent Psychiatry.

Studies show that medication, along with behavior and cognitive therapy and a supportive school environment, is often the best strategy to treat the disorder.

Research also shows that children and teens with ADHD who are not treated have a higher risk of failing school and of engaging in criminal behavior, and have more trouble making and keeping friends.

The FDA may agree to another recommendation made by last month's advisory committee to provide an informational booklet on safety issues with all ADHD medications. However, an FDA official expressed doubts about the wisdom of the black box recommendation.

"We don't usually write a black box for something there isn't pretty good evidence for," said Dr. Robert Temple of the FDA's Office of Medical Policy.

Some doctors say the controversy is regrettable.

"Now you have 2.5 million parents worrying about something where there is probably no reason for them to be worrying," Adesman says. "Physicians throughout the country were flooded with phone calls. And there are families who, despite reassurances from their physician, will have unnecessary cardiac evaluations or will take their kids off the medications."

Nancy Starke was among the worried parents. When she heard about the cardiac risk, she dashed off an e-mail to her daughter's doctor.

"It alarmed me," says Starke, who lives in Los Angeles. "But I also thought there was probably more to the story."

Starke's daughter's doctor reassured her that the risk, if it even exists, is extremely low. That's good news, Starke says. "The medication makes her so much more productive and helps her attitude."

Teri Burley, the mother of two teenage sons with ADHD, took a deep breath when she heard the news. But, as a leader with a local chapter of the nonprofit support group Children and Adults with Attention Deficit/Hyperactivity Disorder, Burley says she has learned to do her own research.

"I get on the Internet and look for information," the Placentia woman says. "I call doctors. I get second and third opinions. Sometimes I call drug companies and ask for more information. I try to do the research and then make a choice."

Burley opted to keep her sons on medication. "I think the risk is very slim and that the benefits outweigh the drawbacks. And no medication is perfect."

Many parents are initially reluctant to put their kids on stimulant medications and remain uneasy about the treatment, Robb says. The current controversy may add to their hesitation.

"It also scares people from coming in for treatment," she says. "Instead they don't do anything and the kids continue to struggle."



A medication used to treat the sleep disorder narcolepsy may soon be approved to treat attention-deficit hyperactivity disorder.

A Food and Drug Administration advisory committee will review the safety and effectiveness of the drug, which is known by the generic name modafinil, at a hearing Thursday.

Cephalon, the maker of modafinil, now sells the medication under the brand name Provigil for narcolepsy, which is an extreme tendency to fall asleep during normal daytime activities. But studies have shown that the medication also helps people with ADHD.

In a report published in the December issue of the journal Pediatrics, children and adolescents taking the medication in a randomized, double-blind study showed significant improvement in such symptoms as inattention, impulsivity and hyperactivity.

About 48% of the patients taking the medication were rated as "much" or "very much" improved by their doctors compared with 17% of the patients taking a placebo. The drug did cause side effects in some children, including insomnia and decreased appetite, according to Dr. Joseph Biederman, lead author of the study and professor of psychiatry at Harvard Medical School.

If approved for treating ADHD, the drug would be sold under the name Sparlon. The medication is a stimulant but is chemically different than Ritalin, which is a brand name for the generic drug methylphenidate.


-- Shari Roan

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