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Standardized information needed for ADHD stimulant medications

As a general pediatrician as well as a specialist in the field of learning and attention difficulties, I follow my medicated patients with ADHD much more closely than I did when I went into practice almost 30 years ago. However, the use of a “black box warning” for all the stimulants by the FDA will only serve to confuse patients and parents. What is needed and is finally being developed are standardized information sheets for parents along with clear recommendations for prescribing clinicians as to indications and parameters to follow to minimize the risk.

The understanding and diagnosis of ADHD has changed considerably since the 1960s when it was known as “minimal brain dysfunction.” While the various preparations available for drug treatment of this disorder have expanded widely since then, the same three drugs – dextroamphetamine, amphetamine and methylphenidate –are still the only stimulant drugs available.

Stimulant medications have proven to be safe
New preparations that take advantage of innovations in allowing the drugs to provide longer and steadier availability in the blood stream have become more popular, but no new stimulant is in use. One very good reason is that these drugs have proved incredibly safe. That is not to say that they do not have side effects. Insomnia, irritability, decreased appetite (and consequent slowing of growth), headaches and stomachaches are commonly seen, but sudden death has only been reported in 12 children under 18 years with amphetamines and seven with methylphenidate. Any stimulant drug, including those available over-the-counter for other uses, can raise blood pressure and heart rate.

Dr. Steven Nissen, an adult cardiologist and interim chair of Cardiovascular Medicine at the Cleveland Clinic, was a consultant to the FDA’s Drug Safety and Risk Management Advisory Committee for the hearings on ADHD drugs, which voted 8 to 7 in favor of the black box warning. He explains in the April 4, 2006 issue of the New England Journal of Medicine his concern about all stimulants – not just the ones for ADHD. He also puts forth his point of view that far too many children and adults are taking all sorts of stimulant drugs with little concern for the potential dangers. He does not acknowledge the enormous benefit of the prescription stimulant for children suffering every day with the effects of attention deficit disorders.

Concern regarding misuse of stimulant medications
A major concern regarding the use of stimulant medications to treat ADHD in adolescents and young adults has been the risk that they will be misused or diverted to those for whom they have not been prescribed. A new study from Massachusetts General Hospital researchers has found that, while the great majority of young people with ADHD use their medications appropriately, a small percentage are likely to abuse or to sell prescribed stimulants. The report, appearing in the April 2006 Journal of the American Academy of Child and Adolescent Psychiatry, also identifies factors that may characterize those most likely to misuse their drugs and suggests potential strategies to reduce the risk. It’s important for physicians to go over the risks with their patients and their parents as well as the dangers of drug interactions, including alcohol, marijuana and over the counter stimulants.

Since the publicity about the black box recommendation, statements from the AAP as well as the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatrists have come out against this recommendation. They all recommend following patients more closely on stimulant medications and providing better information for patients and prescribers.

The best way to protect children is for pediatricians and parents to look carefully at the risk-benefit-ratio for any drug prescribed for a child.  If the child being treated has a condition other than ADHD or a significant second condition (comorbidity) not yet identified in the child, the potential benefit of the stimulant drug goes down, thus raising the relative risk. For children who have been adequately evaluated and diagnosed with ADHD, who do not have a structural abnormality of the heart, the risk of sudden death is incredibly low. Children with ADHD need a comprehensive treatment plan that includes educational and behavioral interventions as well as medication. 

The AAP developed an “ADHD toolkit” several years ago to assist pediatricians in the appropriate diagnosis and treatment of children presenting with symptoms of ADHD. When pediatricians utilize these materials (available without charge for members of the AAP), they significantly lower the risks for their patients and increase the benefit of the medications they prescribe.

Ronald Angoff, MD, FAAP, is an attending pediatrician at the Yale-New Haven Children’s Hospital and an associate clinical professor of the department of pediatrics and the Yale Child Study at the Yale University School of Medicine.