Safety Alerts & Recalls

What does this mean?

The FDA will continue to collect and review all available information on the potential risks of stimulant medications in children including results from a large on-going study that will complete later in 2009. The FDA will update this advisory when additional information becomes available. Until that time, the FDA states that these early safety findings should not serve as a reason for parents to stop a child's stimulant medication.

Although this FDA notice only applies to the use of stimulant medication for ADHD in children, both adults taking stimulants and parents who care for children who take stimulants may want to use this alert as a reminder to review the risks and benefits of treatment with your health care provider. If you or a child you care for develop cardiovascular symptoms, such as chest pain, shortness of breath or fainting, while taking a stimulant medication like pemoline (Cylert), you should contact your physician immediately.

Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children

A recent study published in American Journal of Psychiatry suggests there may be a link between the use of stimulant medications for attention-deficit hyperactivity disorder (also known as ADHD) and sudden cardiac death in healthy children. In the study, the investigators compared the use of stimulant medications in two groups of children in the United States: one group of 564 healthy children who died suddenly from unexplained heart related problems and one group of 564 children who died as passengers in a motor vehicle accident. According to the study report, 10 of the healthy children who died suddenly from unexplained heart problems, or 1.8% of the group, were reported to be taking a stimulant medication at the time of death. This compared with only two cases of stimulant use, or 0.4%, among healthy children who had died in motor vehicle accidents.

At this time, the FDA is reviewing the results of the study and is unable to conclude that the results of the study affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. The FDA says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study.

Prescription stimulant medications are used to treat ADHD, a continuous pattern of inattention and/or hyperactivity-impulsiveness that is more severe than expected for a child's developmental age. Examples of stimulant treatments for ADHD include: dexmethylphenidate (Focalin, Focalin XR), dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR), mixed salts amphetamine (Adderall, Adderall XR), pemoline (Cylert), and generics.

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Source: FDA
Publication Date: 2009-06-16
Last Updated: 2009-12-05

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