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MICHIGAN FREE PRESS

Weigh Ritalin risks", default", doctors say

"Parents and schools should be aware of these risks," Dragovic said Friday in a telephone interview.

Area patients see pros, cons of use

February 11, 2006

BY PATRICIA ANSTETT AND
CHASTITY PRATT

FREE PRESS STAFF WRITERS

So just how safe is Ritalin? Is there really a risk?

The millions of people who take it and other types of stimulant medicines for attention disorders are likely to ask those kinds of questions for months after a federal advisory committee recommended Thursday the strongest warning labels be put on the prescription drugs.

The Food and Drug Administration had asked the committee to study the drugs following reports of 25 sudden deaths of people taking the stimulants. One may have been 14-year-old Matthew Smith of Clawson.

He died of a heart attack in 2000, collapsing after skateboarding in his aunt's basement. He had taken Ritalin for eight years.

Oakland County Medical Examiner Dr. Ljubisa Dragovic, who favors strong warning labels on the drugs, reported Smith's death to the FDA in 2000. The autopsy found enlarged heart vessels from longtime stimulant use, Dragovic said.

"Parents and schools should be aware of these risks," Dragovic said Friday in a telephone interview.

Kelly and Lawrence Smith, Matthew's parents, have spent the last five years lobbying for stronger warning labels. The Web site for their National Alliance Against Mandated Mental Health Screening and Psychiatric Drugging of Children, www.ritalindeath.com, gets 2,000 visitors a day and has had over four million visitors, Lawrence Smith said Friday.

"Now all these kids are dying ... and they still continue to push it," he said. "It's just money, it's all about the money."

Last year, there were $3.6 billion in sales for attention disorder drugs, according to industry figures.

Safe for many users

Within psychiatry, the drugs are viewed as widely safe and effective for as many as 70% of those who take them, experts say. They help reduce hyperactivity, the hallmark symptom of Attention-Deficit/Hyperactivity Disorder, and disorganization and inattentiveness, common symptoms of Attention Deficit Disorder. Possible side effects include sleep loss, appetite loss and dry mouth, and sometimes, increased heart rate, though symptoms often wane after continued use.

They've always generated controversy, in part because so many people take the drugs -- 2.5 million children and 1.5 million adults.

"I've used these drugs with thousands of people over the years and I'm unconvinced there's any reason to be fearful," said Dr. Joel Young, a Rochester Hills psychiatrist who fielded 10 phone calls by noon Friday from people asking about the recommendation. A consultant to several stimulant manufacturers, Young is respected in the area by patients and advocacy groups.

Dr. David Rosenberg, a professor of child psychiatry and psychology at the Wayne State University School of Medicine and Children's Hospital of Michigan in Detroit, called the drugs some of the safest in medicine. Still, he's happy the news will call attention to the need for a precise diagnosis and proper evaluation of a person before drugs are prescribed.

"Not every child who is hyperactive or who is bored in class" has an attention deficit problem, he said. "Most don't." Still, most children with the problem are never diagnosed, he added.

Novartis Pharmaceuticals Corporation of East Hanover, N.J., which makes Ritalin, released a statement Friday.

"Based on our review of our global safety database over 50 years, there does not appear to be an increase in cardiovascular events ... when viewed in the context of the expected rates in the general population. We recognize that these are complex issues and will work with the FDA to do what is in the best interest of patients with ADHD."

Concerns about side effects, as well as reticence to take any drug, deter people from getting help, doctors and ADD experts say. One was Bob Bunnell, 35, a Royal Oak events producer.

"I really didn't want to take a pill," he said.

Four years ago, after a relative told him how much she was helped by a stimulant, he went to Young and agreed to try a drug for his ADD. "The main thing it's done for me is give me a consistent level of energy."

He plans to continue taking the drug.

Other solutions

Drugs aren't the only way to address attention disorders, but Rosenberg pointed out that comparison studies showed no improvement in key symptoms in people who received counseling alone.

Another medicine, Strattera, is a non-stimulant. But it works best for people who have both anxiety and attention problems, Rosenberg and Young said.

Others turn to organizational experts and coaches like Terry Matlen, a Birmingham mother with ADD. Her Web site, www.addconsults.com and her book, "Survival Tips for Women with AD/HD: Beyond Piles, Palms & Post-Its" (Specialty Press, Inc., $17.95) offer advice for people whose brains are wired a little differently.

"I think most of these strategies are an adjunct to medications," she said.

Linda O'Brien of Sterling Heights has sons, 21 and 14, who both have taken Ritalin since age 4. Without the drug, they struggle to socialize, concentrate or keep still.

"My younger son has very, very poor short-term memory; you tell him to do something and he'll take three to four steps and forget," she said.

She expects her sons to use Ritalin indefinitely even if the strongest warning is added.

"The good far outweighs the risk," O'Brien said. "Without it, for a lot of kids there's the risk of dropping out, jail, continued failure as an adult, even suicide."

Contact PATRICIA ANSTETT at 313-222-5021 or anstett@freepress.com.

Photo of Matthew Smith

Matthew W. Smith

NEWS AT A GLANCE

What happened: An advisory committee to the federal Food and Drug Administration has asked the agency to place the strongest warning label possible on Ritalin and other stimulants prescribed for attention disorders. The committee addressed reports of 25 deaths, strokes and heartbeat irregularities linked to the drugs.

What's next: No decision is expected soon. Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said at a news briefing Thursday, "We don't think anything different needs to be done right now."

Across the border: Last year, Health Canada, the FDA equivalent in Canada, ordered Adderall XR, an extended-release form of a hyperactivity drug, to be withdrawn from the market. Six months later, the drug's manufacturer was allowed to resume sales after it made label changes about heart risks and the danger of misusing the drug for recreational purposes.

Patricia Anstett

and the New York Times

 

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