Stimulant Use Linked to Sudden Death in Children Without Heart Problems
2009; American Medical Association; Volume: 302; Issue: 6 Linguagem: Inglês
10.1001/jama.2009.1115
ISSN1538-3598
Autores Tópico(s)Cardiac pacing and defibrillation studies
ResumoCHILDREN AND ADOLESCENTS WITHout apparent underlying heart problemsmaybeat increasedrisk of sudden unexplained death when taking stimulant medications such as methylphenidate, suggests a recent study. However, the US Food and Drug Administration (FDA), which partially funded the study, said the findings are not robust enough to call for a change in the prescribing of these medications. Reports to the FDA and in the medical literature of serious cardiovascular adverse events and sudden death among children takingstimulantmedications for attention-deficit/hyperactivity disorder (ADHD) have sparked concern about the safety of these drugs. In fact, the labels for methylphenidate and amphetamine medications were changed in 2006 to note reports of stimulant-related deaths in patients with heart problems and advise against using these products in individuals with known serious structural abnormalities of the heart, cardiomyopathy, or serious heart rhythm abnormalities. Yet there have been insufficient data to confirm whether taking stimulant medication causes cardiac problems or sudden death. There is a plausible biological mechanism by which methylphenidate and other medications used to treat ADHD might cause cardiac problems because, like other stimulants, they cause the heart to beat faster, noted Robert Temple, MD, acting director of the FDA’s Office of Drug Evaluation I, during an FDA press briefing after the release of the study. Such effects would be particularly harmful to those with underlying cardiac problems. “The question has always been is there reason to be concerned about such a risk in individuals who don’t have underlying heart disease,” Temple said. To provide such necessary data, Madelyn S. Gould, MPH, PhD, of Co-
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