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FDA Won’t Change Warnings on ADHD Drugs Following Study on Heart Death Risks

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Federal health regulators say prescribing information for ADHD drugs like Ritalin, Adderall, Dexedrine, and Concerta won’t change, despite publication of a study that found the medications might increase the risk of sudden heart death in children.  According to the Food & Drug Administration (FDA), the study – which was funded by agency and the National Institute of Mental Health – had limitations which prevent it from  concluding  that the data presented  affect the overall risk-and-benefit profile of stimulant medications used to treat ADHD in children.

According to the FDA, the study compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. Researchers  concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes than among those who died in car crashes. According to the study report, out of the children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of those who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death.

However, the FDA maintains that the study had several limitations, including the significant time lag between when the deaths occurred  and when the information was collected.    The agency said that parents should not stop a child’s stimulant medication based on the study. Instead, parents  should discuss concerns about the use of these medications with the prescribing health care professional, FDA said.

Labeling for drugs like Ritalin, Adderall, Dexedrine, and Concerta already include  warnings about the risk of sudden cardiac death in patients with heart problems, but they have been considered safe for children who don’t have pre-existing heart conditions.   There have been worries, however, that such stimulants could be risky in children with undiagnosed heart problems.  It is not known how often cardiac events  occur in children taking these drugs.

Last year, the American Heart Association recommended screening all children and teens taking ADHD drugs for hidden heart problems, as well electrocardiogram  screening of all patients being placed on the stimulants for the first time.

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