Study Associates ADHD Meds with Unexplained Deaths, but FDA Advises Parents not to Panic

By Hugh C. McBride

Intense fidgeting. An inability to pay attention. A tendency to interrupt, ignore, or otherwise disobey.

For families of children with Attention Deficit Hyperactivity Disorder (ADHD), life without the drugs that suppress many of the more severe symptoms is virtually unthinkable.

But a recently released study that was funded by the U.S. Food and Drug Administration (FDA) and the National Institute of Mental Health (NIMH) has caused many parents to fear that the medications they give their children to improve the quality of their lives may be putting those same lives at risk.

However, the FDA has cautioned parents that the study's small sample size, and the fact that the benefits of ADHD meds outweigh the risks, should not cause them to change their child's ADHD medication regimen without first consulting with their family physician.

ADHD Medications and Unexplained Deaths

According to a June 15 article by Dan Childs and Todd Neale of the ABC News medical unit, the concerns are the result of reports of sudden and unexplainable deaths among apparently healthy young people:

In the study of 564 children and teens who died suddenly, researchers led by Madelyn Gould of the New York State Psychiatric Institute and Columbia University in New York City found that those who died suddenly were 7.4 times more likely than not to have been taking the stimulant medications. The results of the study are reported online in The American Journal of Psychiatry.

"Although sudden unexplained death is a rare event," the researchers said, "this finding should be considered in the context of other data about the risk and benefit of stimulants in medical treatment."

A June 16 article by Washington Post staff writer Shankar Vedentam provided the following details from the Gould study:

The researchers obtained information about 564 children in the United States who died suddenly and inexplicably between 1985 and 1996. They evaluated how many of the children who died had been taking stimulant drugs by asking their parents and caregivers and by reviewing medical documents.
For every child who died suddenly and inexplicably, the researchers then found another child closely matched in terms of age, sex, and other variables who died in a traffic accident. Taking a stimulant drug is unlikely to have played any role in a child getting killed in an accident.
If stimulant drugs had nothing to do with sudden, unexplained death, then the number of victims on stimulant drugs who suffered such deaths and the number of victims on stimulant drugs who died in traffic accidents ought to have been about the same.
Gould and her fellow researchers found that 10 children in the group that suffered sudden, unexplained death had been taking stimulant drugs, whereas only two children in the group killed in traffic accidents were taking such medications.

Gov't Groups Move to Ease Parents' Minds

In the aftermath of the ADHD medication study's publication, officials with both the FDA and the NIMH, as well as the leader of the study herself, advised parents not to make any changes in their children's medication regimens without first consulting with their physician.

“We don’t want to make parents so scared that they would take their children off ADHD medications,” Gould told Nancy Shute of U.S. News & World Report's On Parenting blog. "The very last thing we would want is for a parent to take a child off medication that is working for them.” Instead, Gould told Shute, her study should encourage physicians to pay increased attention to cardiac screenings for ADHD patients.

In a June 15 statement, the FDA echoed Gould's advice, telling parents that this study does not mean that their children are at risk:

Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. Therefore, the FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional.

Because ADHD medications are known to increase heart rate, doctors have long been advised to screen patients for cardiac problems before prescribing drugs such as Ritalin, Adderall, and Concerta. According to Shute's June 16 post, the FDA and the American Academy of Pediatrics already encourage doctors to take the following steps before prescribing ADHD medications:

Take a medical history for cardiovascular disease in the child and his or her family.
Perform a physical exam with special focus on the cardiovascular system (including examination for signs of Marfan syndrome, a hereditary disorder that increases the risk of heart problems).
Consider further tests, such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease.

About ADHD Meds

Attention Deficit Hyperactivity Disorder cannot be "cured" by medication, but certain drugs have been found to suppress some of the more severe ADHD symptoms. According to a information on the WebMD website, between 70 and 80 percent of patients who take ADHD medications achieve the following results:

Less interrupting, fidgeting, and finger tapping at school, and increased on-task behavior
Better relationships at home with parents and siblings, better focus and on-task behavior, and better compliance with parent requests and authority
Improved social relationships and increased attention during sports and other activities

The three most commonly prescribed ADHD medications are Ritalin, Adderall, and Concerta. Health care experts estimate that about 2.5 million U.S. children take these or other drugs to treat symptoms of ADHD.

Because individuals with ADHD often appear to be overly stimulated, many people mistakenly assume that ADHD medications are depressants. However, Ritalin, Adderall, and Concerta are all stimulants. Ritalin and Concerta contain methylphenidate, a stimulant that is derived from amphetamine, while Adderall consists of a combination of amphetamine and dextroamphetamine.

Stimulants affect the brain by triggering increased release of dopamine, a brain chemical that is associated with pleasure and movement. Though researchers do not completely understand why stimulants such as Ritalin, Adderall, and Concerta are as effective as they are, recent studies indicate that the drugs target the prefrontal cortex, the area of the brain that is associated with paying attention, making decisions, and expressing one's personality.

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Study Associates ADHD Meds with Unexplained Deaths, but FDA Advises Parents not to Panic