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Doctors Debate Ritalin Warning; FDA Panel Reports Some Heart Risks

Posted on: Monday, 13 February 2006, 15:00 CST

By BOB GROVES, STAFF WRITER

Therapists in New Jersey disagreed Friday about whether stimulants such as Ritalin, used in treating behavior problems, should carry federally recommended warnings of heart risks.

"Personally, I think a 'black box' [warning] is premature," said Dr. Peter Heilbroner, a pediatric neurologist at The Valley Hospital in Ridgewood.

"I think it's going to scare off patients, including some that would benefit" from taking drugs, such as Ritalin, that successfully treat millions of patients for attention deficit hyperactivity disorder, Heilbroner said.

An advisory panel to the Food and Drug Administration reported recently that sudden deaths occurred among 25 stimulant users, mostly children, in 1999 to 2003, and that the drug labels should warn of potential risk of stroke or arrhythmia.

Ritalin, the brand name for methylphenidate, amphetamines such as Adderall, and other stimulants are known to elevate heart rate and blood pressure.

Heilbroner said he prescribes a lot of stimulant medication, including Ritalin, for his patients with ADHD.

"It enables them to function better academically, socially and behaviorally to a marked degree," he said.

Black box warning labels would be "unnecessary" on stimulants if all patients were screened properly first, said Dr. Tolga Taneli of the University of Medicine and Dentistry of New Jersey.

Instead of labels, the FDA should review whether children should be given an EKG or other tests to determine if they have a preexisting heart condition, said Taneli, a child and adolescent psychiatrist at University Hospital in Newark. Warning labels might cause general practitioners to prescribe Ritalin less, or to refer more patients to specialists for second opinions before prescribing stimulants, Taneli said.

Otherwise, "It's undisputed that stimulants are very effective for conditions of ADHD," he said.

Dr. Jasmin Furman of Hackensack University Medical Center said that prescription drug warning labels have a positive side.

"What we found with black box warnings is that parents usually feel it protects them, and it puts in another safety valve," said Furman, a developmental behavioral pediatrician at Hackensack.

"It usually makes parents aware, then it's up to them to decide whether to continue using the medication," said Furman, who treats many patients with stimulant drugs, including Ritalin.

"We have prescribed it. We find it very useful for appropriate reasons," she said.

"On the other hand, it might make some physicians feel they don't want to write a prescription" for the drug, if it carries a black box, she said.

"All I'm saying is, once they decide to have a warning, we would follow it," she said.

Dr. Randye Huron, director of the Institute of Child Development at Hackensack, agreed.

"We're very prudent about medication management here," Huron said.

"I always think if things are used and prescribed carefully for the right reason, that's a good thing," Huron said. "To keep children from getting treatment that's appropriate wouldn't be a good thing.

"Certainly there are two sides. The FDA has a big decision to make," Huron said.

Source: Record, The; Bergen County, N.J.

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