ADHD drugs driving thousands to the ER

According to the fist national estimates of the problem, accidental overdoses and side effects from attention deficit hyperactivity disorder (ADHD) medications likely send thousands of children and adults to emergency rooms.

Scientists with the US Centers for Disease Control and Prevention estimated adverse events from the stimulants drive nearly 3,100 people to ERs every year. Nearly two-thirds – overdose and accidental use – could be prevented by parents putting the pills out of reach, the researchers said.

Other patients experienced adverse side effects, including stroke, hypertension, chest pain and rapid heart rate.

Concerns over those effects have led some doctors to urge the FDA to require a “black box” warning, the most serious it issues, on package inserts for drugs like Ritalin, Adderall and Concerta. However, even doctors advising the FDA can’t seem to agree on whether or not that’s necessary.

The issue was discussed in a recent New England Journal of Medicine, including letters from some physicians concerned over the dangers of not treating ADHD.

Dr. Tolga Taneli, a child and adolescent psychiatrist at the University of Medicine and Dentistry of New Jersey in Newark said, “The numbers (of side effects) are puny compared to the numbers of stimulant prescriptions per year. I’m not alarmed.”

It’s estimated that 3.3 million young people 19 or under and almost 1.5 million men and women over age 20 take ADHD drugs. Ritalin is made by Novartis Pharmaceuticals Corp. of East Hanover, NJ; Concerta by Johnson & Johnson of New Brunswick, NJ; and Adderall by Shire US Inc. of Newport, KY.

Between 1999 and 2003, the FDA reported 25 deaths linked to ADHD medications, 19 of those involving children. Fifty-four other cases of serious heart problems, including strokes and heart attacks, were also reported. Some of the patients had prior heart problems.

Even still, there has been no clear estimate of the scope of side effects. The CDC report, while not a rigorous scientific study, seeks to provide that by using a new hospital surveillance network.

The researchers counted 188 ER visits for problems related to the drugs at 64 hospitals in this network from August 2003 to December 2005. They linked use of ADHD stimulants to 73 patients with side effects or allergic reactions. An additional 115 accidentally swallowed ADHD pills, including a one-month-old baby, or took too large a dose.

“These are cases where a young child took someone else’s medication or they took too much of their own,” says CDC epidemiologist Dr. Adam Cohen, citing the second group.

Almost 1 in 5 of these individuals was admitted to the hospital, 1 in 5 needed stomach pumping or medicinal treatment, and 1 in 7 experienced cardiac symptoms. Sixteen percent of the side effects involved interaction with another drug.

Other common symptoms included rashes, weak or painful muscles, spasms and abdominal pain, but no patients died. The researchers estimated 3,075 ER visits occur every year when taking all US hospitals into account.

The heads of the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association wrote in another letter in the journal, that they are worried a black box warning would discourage use of the drugs, raising patients’ risks of substance abuse, problems in school and other issues.

An FDA advisory panel voted in February 8-7 for a black box warning. The following month, another FDA panel instead recommended data on cardiac and other risks be placed in a new “highlights” section in the drug inserts.

Some physicians, such as Dr. Marsha Rappley of Michigan State University, believe the vote for a black box warning was premature.

Rappley said studies show the drugs raise blood pressure and pulse rates some, but it’s not known if that would harm children taking them for years, and that cardiac risks may be higher for adult patients.

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Cardiology chief Dr. Steven Nissen of the Cleveland Clinic, who pressed for a black box warning at the FDA panel meeting, said these drugs are powerful stimulants and thus, inherently risky. Nissen and other doctors say the drugs are being prescribed to some patients for whom they’re not necessary.

The FDA says it is “working diligently” on “labeling changes” they deem accurately reflect the available data on the subject and the committees’ advice.

© Copyright 2007 Insight Journal Online Magazine.

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