Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem.
Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds – overdoses and accidental use – could be prevented if parents locked the pills away.
Other patients had side effects, including potential cardiac problems such as chest pain, stroke, high blood pressure and fast heart rate.
Concerns over those effects have led some doctors to urge the Food and Drug Administration to require a “black box,” its most serious warning, on package inserts for drugs such as Ritalin, Concerta and Adderall.
However, some doctors advising the FDA don't agree on whether that warning is warranted.
The issue was discussed in a series of letters in today's New England Journal of Medicine, including some from doctors worried about the dangers of not treating attention deficit hyperactivity disorder.
“The numbers (of side effects) are puny compared to the numbers of stimulant prescriptions per year,” said Dr. Tolga Taneli, a child and adolescent psychiatrist at the University of Medicine and Dentistry of New Jersey in Newark. “I'm not alarmed.”
An estimated 3.3 million Americans 19 or younger and nearly 1.5 million 20 and older are taking ADHD medicines. Ritalin is made by Novartis Pharmaceuticals of East Hanover, N.J.; Concerta by Johnson & Johnson of New Brunswick, N.J.; and Adderall by Shire US in Newport, Ky.
Twenty-five deaths linked to ADHD drugs, 19 involving children, were reported to the FDA from 1999 through 2003. Fifty-four other cases of serious heart problems, including heart attacks and strokes, also were reported. Some of the patients had prior heart problems.
There hasn't been a clear estimate of the scope of the side effects. The CDC report, while not a rigorous scientific study, attempts to provide that.
In one of the journal letters the directors of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry expressed concern that a black box warning would discourage use of ADHD drugs, raising patient risks of academic failure, substance abuse and other problems.
In February, an FDA drug safety panel voted 8-7 for a black box warning. The next month, another FDA panel recommended data on cardiac and other risks go in a new “highlights” section the agency plans to add to the top of drug inserts.
