FDA Drug Safety Communication

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FDA Date: 7/31/10

Adderall (mixed salts amphetamine) FDA Drug Safety Communication

Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

The results of the ongoing study sponsored by FDA and AHRQ to research potential serious cardiovascular risks associated with medications used to treat ADHD in children and adults has been further delayed. The results of both studies, known as the Multicenter Observational Cohort Study to Assess the Cardiovascular Risks of Medications Prescribed for Attention Deficit and Hyperactivity Disorder (ADHD), are now expected in the first quarter of 2011. This delay is due to the logistical challenges of obtaining approximately 2,000 medical charts to confirm medical claims diagnoses, as well as the technical challenges associated with pooling and analyzing data from approximately 1.5 million patient records across 12 health plans. Program officials from FDA and AHRQ continue their close contact with the investigators and will provide updates once results are obtained and reviewed.

FDA recommends that healthcare professionals follow all the current prescribing information for use of these medications, including:

- Take a medical history for cardiovascular disease in the child and his or her family.

- Perform a physical exam with special focus on the cardiovascular system (including examination for the signs of Marfan syndrome).

- Consider obtaining further tests such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease.

FDA intends to update this advisory when additional information or analyses become available.

Examples of products involved in the FDA review include: 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.

View the full FDA Drug Safety Communication on FDA.gov