ADHD Drugs Pose Heart Risks, Federal Panel Says


    By Janessa Cloward

    Risks of serious injury and even death associated with stimulants to treat attention-deficit (hyperactivity) disorder merit stricter warning labels for those drugs, a federal panel said.

    The panel advised the Food and Drug Administration to add a “black box” warning to methylphenidates like Ritalin to emphasize potential cardiovascular problems the drugs could cause. Although the FDA doesn”t need to heed the panel”s advice, it often does.

    The panel”s announcement came after an FDA database search found 25 deaths – including 19 children – linked to the stimulants in the past five years.

    Utah has the 10th lowest rate of ADHD diagnosis in the nation, but local pharmacists and psychiatrists still see plenty of cases in both children and adults.

    According to the Utah Health Data Committee Web site, psychiatrists in Utah prescribed more than 1.7 million doses of methylphenidates in 2003. Ritalin, Concerta, Methylin and Metadate – all candidates for the label change – were prescribed most frequently.

    Marianne Hawkins, a nurse at Utah Valley Regional Medical Center”s outpatient psychology office, said the psychiatrists she works with try to avoid prescribing medication if at all possible.

    ADHD occurs in people of all ages, but until 2001, only children were diagnosed. Hawkins said adults are rarely diagnosed and treated for ADHD in her office. She estimated about 97 percent of ADHD patients she worked with were children.

    When a child is diagnosed with ADHD, psychiatrists meet with the child”s parents to map out a behavior modification plan. This includes setting goals and counseling with the parents and child to reach those goals. Teachers are often involved, too.

    If behavior therapy doesn”t work, a psychiatrist will prescribe methylphenidates. Usually mixing behavior therapy with a low dose of the drugs is the best cure. Dosage tapers off as the child grows up until the drugs are no longer needed.

    Hawkins said if the psychiatrists see any side effects, the child would immediately stop taking the drugs and possibly switch to another brand.

    Although the FDA database search found deaths linked to methylphenidates, she has never seen long-term side effects in her patients.

    Ritalin, the most well-known methylphenidate, has been on the market since 1955. Laurie Ostroff-Landau, spokesperson for Ritalin”s producer, Novaris, said extensive clinical trials were run before Ritalin hit the market 50 years ago. Research on its safety has continued since.

    “The package insert reflects our studies, and it says patients with hypertension and other cardiovascular problems should be very careful while on Ritalin,” Ostroff-Landau said.

    When a doctor first prescribes a methylphenidate to a child, she said the first step is to check that child”s family history. Any cardiovascular problems in the immediate family, including irregular heart rhythms and fainting spells, and the child must see a pediatric cardiologist before starting the drugs.

    As for the possibility of a label change, Ostroff-Landau said Novaris would fully cooperate with whatever the FDA decides to do. However, she pointed out, at this point the label change is only a recommendation, not a requirement.

    “Whatever happens, we will work with the FDA to do what is in the best interest of the patients,” she said.

    Jim Averett, a pharmacist at the BYU Student Health Center, said heart irregularities occur in more than 1 percent of all patients who take methylphenidates, but worst-case scenarios like sudden death are extremely rare.

    “There are always going to be risks involved with medication,” he said. “You as the patient need to decide if the benefits outweigh the risks.”

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