By Shannon Pettypiece
June 15 (Bloomberg) — Drugs to treat attention deficit disorder were linked to an increase in sudden death among children, according to a government-sponsored study.
The U.S. Food and Drug Administration, which funded the research with the National Institutes of Health, said the study had “limitations” and shouldn’t stop patients from taking the treatments. The findings, published today in theAmerican Journal of Psychiatry, showed that more children who died suddenly from heart complications or unknown causes were taking an attention-deficit drug than those who died in car accidents.
Attention-deficit medicines already carry the FDA’s strongest warning in their prescribing information about sudden death and cardiac risks. Doctors should assess patients for heart risks when prescribing stimulant-based drugs, such as Shire Plc’s Adderall and Novartis AG’s Ritalin, the agency said.
“The FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication,” the agency said today in a Web site posting. “Parents should discuss concerns about the use of these medicines with the prescribing health-care professional.”
The agency said it will release a more definitive study on the potential risk later this year.
The research found that of 564 healthy children who died suddenly, 10 were taking stimulant medications at the time of death, the FDA said. That compares to two stimulant users among 564 children who died in traffic accidents.
The low use of stimulants in both groups may have affected the results, as well as inaccuracies in recording drug use by the children, the FDA said.
To contact the reporter on this story: Shannon Pettypiece in New York atspettypiece@bloomberg.net.
