Unexplained deaths higher among children taking Ritalin, study says

Children taking stimulant drugs such as Ritalin to treat attention-deficit hyperactivity disorder (ADHD) are several times as likely to suffer sudden, unexplained death as children who are not taking such drugs, according to a study published Monday that was funded by the Food and Drug Administration (FDA) and the National Institute of Mental Health.

While the numbers involved were small and researchers stopped short of suggesting a cause and effect, the study is the first to rigorously demonstrate a connection between ADHD drugs and sudden death among children.

Doctors have speculated about such a connection because stimulants increase heart rate and have other cardiovascular effects. Physicians currently are advised to evaluate patients for cardiac risks before prescribing the drugs, and FDA officials said Monday that those guidelines do not need strengthening. Some 2.5 million children in the United States take ADHD medications such as Ritalin and Adderall.

FDA officials said Monday that given the seriousness of ADHD and the rarity of sudden death — which strikes fewer than 1 in 10,000 children — the benefits of the drugs outweigh their risks. Agency officials urged parents to discuss concerns with doctors rather than deciding on their own to discontinue a child's medication. The study's lead author, Madelyn Gould, said she agreed with the FDA's advice.

Gould and colleagues obtained information about 564 children who died suddenly and inexplicably between 1985 and 1996 and evaluated how many had been taking stimulant drugs by asking parents and caregivers and by reviewing medical documents.

For every such child the researchers then found another child closely matched in age, sex and other variables who died in a traffic accident.

Gould 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.