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HealthMarch 6, 2008 

ADHD meds may pose heart danger, study shows
FROM STAFF REPORTS Gulf Breeze News news@gulfbreezenews.com

Stimulant medications used to treat children with attentiondeficit hyperactivity disorder may be responsible for an increased number of visits to the emergency room or doctor's office because of cardiac symptoms, but deaths or serious heart complications are rare, a new University of Florida study reveals.

"Treatment decisions are always a risk-benefit assessment for doctors," said Almut Winterstein, Ph.D., an assistant professor of pharmacy health care administration at the University of Florida's College of Pharmacy. "We know about the benefits of central nervous system stimulants. There are a lot of advantages to the patient - improved concentration, the improved ability to interact socially - but the risks have been very poorly defined."

Despite concerns about the risks of taking medications such as Adderall and Ritalin for the treatment of ADHD - the drugs are known to raise blood pressure and heart rate, and other members of this drug class, such as methamphetamine, are associated with serious adverse effects - use of the drugs has steadily risen over the past decade.

Winterstein, a pharmacoepidemiologist, led a team of researchers in pharmacy, pediatric medicine and psychiatry who analyzed records from 55,000 children ages 3 to 20 who had ADHD and were undergoing treatment between 1994 to 2004. The UF study, which sought to assess the effects of these drugs on the risk for heart disease, relied on the Florida Medicaid database of more than 2 million youth, cross-matched with vital statistics records - the first of this magnitude in ADHD safety research.

The researchers published their findings Saturday (Dec. 1) in the journal Pediatrics.

Children who used central nervous system stimulants were 20 percent more likely to visit an emergency clinic or doctor's office with cardiac-related symptoms, such as a racing heartbeat, than children who had never used or discontinued treatment. The researchers also reported that the rates of death or hospital admission for serious heart conditions were no different than the national rates among the general population, but the total number of events was too small to allow definite conclusions.

Since 1995, the number of patients newly diagnosed with ADHD has grown at a fairly constant rate, Winterstein said. Today, nearly one-third of these patients - more than 5 percent of American children - chronically take stimulant medications.

Approximately 3 million to 4 million youngsters in the U.S. are prescribed stimulant medications for ADHD, said Daniel Safer, M.D., an associate professor in psychiatry and pediatrics at Johns Hopkins University School of Medicine.

Safer added that the major side effects from stimulant treatment are decreased appetite and, in some cases, difficulty falling asleep.

In 2006, the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee recommended a black-box warning regarding the drugs' cardiovascular risks be added to the package insert.

However, the FDA's Pediatric Advisory Committee disagreed, saying there was strong scientific evidence the drugs were beneficial, whereas data regarding risks indicated cardiac effects were often mild and could be treated by adjusting the dose or timing of medication.

The UF research team's recent findings raise several important issues that warrant further investigation, Winterstein said. Critical concerns include stimulant safety in populations with cardiac risk factors and in those who use the drugs for several years. The UF study found that more than 25 percent of stimulant users also used antidepressant or antipsychotic drugs, which are known to affect the heart and blood pressure as well.



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