FDA Releases Findings on ADHD Medications, Potential Link to Sudden Death in Healthy Children
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The FDA recently notified healthcare professionals that it is providing its perspective on data published in the American Journal of Psychiatry concerning the potential risks of stimulant medications used to treat children suffering from Attention-Deficit/Hyperactivity Disorder (ADHD). This study, which was funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in motor vehicle accidents. The study's authors concluded that there could be an association between the use of stimulant medications and sudden death in healthy children.
Considering the limitations of this study's methodology, the FDA was unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. Accordingly, the FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. However, parents should discuss concerns about the use of these medicines with their child's treating physician. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.
The following medications were included in the study: Focalin, Focalin XR (dexmethylphenidate HCl); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.
More information is available at the FDA's web site: http://www.fda.gov.