Attention Deficit Disorder Drug Ritalin May Cause Heart Problems

March 19th, 2006

If your child has been labeled “hyperactive” by a teacher, you might think twice before resorting to a drug such as Ritalin to improve performance in class.  Stimulants such as Ritalin, Concerta and Adderall are the most widely prescribed medications for childhood behavioral problems. Some 2.5 million children and 1.5 million adults are taking them for hyperactivity or attention deficit disorder (ADD or ADHD).

An FDA panel recently voted 8-7 to recommend written guides to patients and to require that prominent, “black box” warnings be placed on drug labels. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and member of the panel voiced “grave concerns” about the harm these drugs may cause. The vote took place after FDA medical officers described reports of 25 sudden deaths, mostly children, among those taking these stimulants.

A biostatistician on the panel went so far as to say that stimulants might be more dangerous to the heart than the painkiller Vioxx, withdrawn from the market in recent years. Some physicians believe the drugs may increase risks of strokes and serious arrhythmias in children and adults, although the risk of heart disease is small in childhood. All panel members agreed that parents of children with known heart conditions should consult their physicians about the use of such drugs.

Ritalin has been marketed since 1955. Dozens of studies have shown it to be safe and effective, although these studies may not have continued long enough to determine risks of long-term use. The soaring popularity of these medications warrants close study as to their potential risks to the heart. Preliminary analysis suggests that heart risks may increase two-fold. With the increasing use of these medications in adults, this data may be more significant for them.

Panel members were deeply divided as to relative risks and benefits of stimulants. Psychiatrists and psychologists who treat patients with attention deficit disorder and hyperactivity disagreed on whether a strongly worded warning was warranted. The director of the Center for Children and Families at the State University of New York voiced the idea that a black-box warning might prompt families to explore behavioral treatments as alternatives to drugs – “a very good outcome for kids with ADHD and their families.” Other FDA officials expressed concern about scaring away many from needed treatment and minimizing the benefits of these drugs. They were unwilling to “sensationalize what is a very low-probability event.”

In March, the FDA will convene a committee made up primarily of pediatricians and psychiatrists on these issues. These clinicians are expected to voice support for continued use of stimulants and be reluctant to frighten patients with black box warnings. Pharmaceutical company representatives agreed to cooperate with the FDA on any label changes.

Sources:  San Francisco Chronicle, 2/10/06, Gardiner Harris, New York Times reporter; New York Times editorial (2/12/06)

Entry Filed under: ADHD, Heart Conditions, ADHD, CHILDREN'S HEALTHCARE