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Experts Discuss ADHD Medication Concerns
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According to the National Institutes of Mental Health (NIMH), attention deficit hyperactivity disorder, ADHD, is one of the most childhood common mental disorders.
Children with ADHD have impaired functioning in multiple settings, including home, school, and in relationships with peers.
If untreated, the disorder can have long-term adverse effects into adolescence and adulthood.
The NIMH states that symptoms of ADHD appear over the course of many months, and include:
- impulsiveness: a child who acts quickly without thinking first.
- hyperactivity: a child who can't sit still, walks, runs, or climbs around when others are seated, talks when others are talking.
- inattention: a child who daydreams or seems to be in another world, is sidetracked by what is going on around him or her.
If ADHD is suspected, the diagnosis should be made by a professional with training in ADHD, according to the NIMH.
This includes child psychiatrists, psychologists, developmental/behavioral pediatricians, behavioral neurologists, and clinical social workers.
After ruling out other possible reasons for the child’s behavior, the specialist checks the child’s school and medical records and talks to teachers and parents who have filled out a behavior rating scale for the child.
A diagnosis is made only after all this information has been considered.
Effective treatments for ADHD are available, and include behavioral therapy and medications, the NIMH states.
Preventive measures to reduce the incidence of ADHD in children are not known at this time. However, early detection and intervention can reduce the severity of symptoms, decrease the interference of behavioral symptoms on school functioning, enhance the child's normal growth and development, and improve the quality of life experienced by children or adolescents with ADHD.
Always consult your child's physician for a diagnosis.
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< July 6, 2005 > -- As the US Food and Drug Administration (FDA) moved to examine a potential link between Ritalin® and cancer, the scientists who first unearthed the connection stress that the finding was preliminary and should not be cause for panic.
The concerns about the medication, a stimulant that has been used to treat attention-deficit hyperactivity disorder (ADHD) for decades, surfaced during a recent FDA pediatrics advisory committee meeting.
The findings, by researchers from the MD Anderson Cancer Center at the University of Texas, showed damage to the chromosomes of 12 children who had taken Ritalin for three months.
Almost 2 million children in the US have been diagnosed with ADHD, according to the National Institute of Mental Health (NIMH). Estimates suggest that between 3 percent to 5 percent of all children have ADHD. Boys are two to three times more likely to have ADHD than girls.
The advisory committee had been called to discuss yet another health issue surrounding the class of ADHD medications known as methylphenidates, to which Ritalin belongs. Some psychiatric side effects have been reported among children using Concerta®, Ritalin, and other versions of these medications.
But the Texas scientists say their Ritalin study was far too small to prompt the parents of ADHD patients to abandon the medication.
"We're not telling people to all go off their medication because you don't know what this means," says Melissa L. Bondy, co-author of the study. "You can't base changing practice on 12 patients. Look how many millions of kids are on this. Do you want to tell all the mothers and fathers to take their kids off of the drugs?"
Dr. Bondy says she and her colleagues have submitted a grant proposal to the National Institutes of Health (NIH) for a larger study looking at more patients and more ADHD medications.
"We definitely need a larger study," says lead researcher Dr. Randa A. El-Zein. The research team is hoping to study roughly 400 children over five years, Dr. El-Zein adds. If approved, the study would not even be funded until March 2006.
The government interest in a larger study is there, however.
Scientists from the FDA, the NIH, and the US Environmental Protection Agency (EPA) traveled to Texas on May 23 to examine the study methods used by the researchers.
"They thought, 'Yes, we do have a public concern,' and that a larger study should be performed," Dr. El-Zein explains.
"We're hoping that they'll see this as a major public health issue, and as something that needs to be done," Dr. Bondy adds.
Meanwhile, the question of labeling changes because of possible psychiatric effects of Ritalin and other methylphenidates have been put on hold after the advisory committee told FDA officials that it was hesitant to recommend such changes.
According to an FDA release, committee members suggested waiting until more safety data have been collected on two other types of drugs used to treat ADHD - methamphetamines such as Adderall® and the non-stimulant Strattera®, something that will not happen before early 2006.
The FDA should "delay the labeling change until they have a good sense of class effect," Acting Committee Chairman Robert Nelson, of The Children's Hospital of Philadelphia, told FDA officials according to the release.
"We heard there is no terrible signal," Office of Pediatric Therapeutics Director Dianne Murphy adds.
The FDA had been considering labeling changes to all methylphenidates with regard to psychiatric events and potential cardiovascular side effects. A review had found 36 psychiatric events for Concerta, compared to 16 for Ritalin and other methylphenidates. These side effects included hallucinations and suicide ideation (suicidal thoughts). Concerta had 20 cardiovascular event reports, while the other methylphenidates had four such reports.
Despite the committee's advice, Dr. Murphy says the agency still may change labeling about psychiatric side effects to "try to make it clearer what the situation is with regard to certain adverse events."
The FDA's decision to take a closer look at the psychiatric side effects of medications for ADHD did not surprise some experts.
"These types of issues theoretically were possible with the medication because of the way it works," says Dr. Lenard Adler, director of the Adult ADHD Program at New York University Medical Center. "It's not surprising that they've had some reports that relate to psychiatric side effects... the drugs have been around for 40 years, and have a 'wide margin of safety.'
"Any medicine that has therapeutic effect can have some side effects," Dr. Adler explains. "This is appropriate scrutiny by the FDA, but the benefits are also very clear and clearly outweigh the risks."
Another expert believes labeling changes may not be the answer.
"Labeling is an oversimplification of the problem," says Dr. Eugenio M. Rothe, director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital and an associate professor of psychiatry at the University of Miami School of Medicine.
"It scares people, and it doesn't address the other problems that are affecting the outcome," he says. "The problem is much more complex than that, and has to do primarily with the stigma associated with mental health conditions."
Always consult your child's physician for more information.
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