Study: ADHD Medications Don’t Increase Heart Risks

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In the largest safety study conducted to date, researchers have found that drugs used by millions of children to treat attention deficit hyperactivity disorder, or ADHD, do not raise the risk of serious heart problems.

The new study is the first in a series of three investigations of ADHD drugs and heart risks commissioned by the U.S. Food and Drug Administration (FDA). The results, published online Tuesday by the New England Journal of Medicine, suggest that such commonly used stimulant drugs as Ritalin, Adderall and Concerta are not associated with an increased risk of heart attack, stroke or sudden death. These events were rare among the children included in the study, and rates didn’t differ between kids who took the drugs and those who didn’t.

Researchers led by Dr. William Cooper, a professor of pediatrics and preventive medicine at Vanderbilt University, looked at the medical records of 1,200,438 children and young adults between aged 2 to 24 (average age 11), including current, past and nonusers of ADHD medications. In total, the researchers found 81 cases of serious heart problems from 1998 to 2005: seven among medication users, 25 among former users, and 49 among nonusers.

MORE: New ADHD Guidelines Include Kids as Young as 4

The findings should reassure many parents whose children take medications to treat ADHD, a condition that causes hyperactivity, impulse control and trouble focusing, and leads to problems in school. An estimated 3% to 5% of children have ADHD — that translates to 5.4 million children aged 4 to 17 diagnosed in the U.S. alone, and 2.7 million who are prescribed medications to treat it each year.

In 2006, reports of heart attacks and strokes in children taking the drugs had caused concern among U.S. and Canadian regulators. Subsequently, Health Canada temporarily suspended marketing of ADHD drugs. The FDA added a black box warning to some drugs, including Adderall, and the American Heart Association recommended that children undergo an EKG test to confirm good heart health before beginning the medications.

On Tuesday, the FDA said it would maintain its warning against the use of ADHD medication among children and young adults with diagnosed heart problems.

MORE: Are Kids With ADHD More Likely to Get Hit by a Car?

“The good news is that it doesn’t look like overall, there’s an increase in cardiovascular events in kids who are on ADHD drugs,” Dr. Gordon Tomaselli, a Johns Hopkins University heart specialist and president of the American Heart Association, told the AP. “The question parents should be asking themselves is, ‘Does my child really need this?'”

Meredith Melnick is a reporter at TIME. Find her on Twitter at @MeredithCM. You can also continue the discussion on TIME’s Facebook page and on Twitter at @TIME.