Safety Alerts & Recalls

What does this mean?

As described in the first FDA safety alert about the Ongoing Safety Review of Stimulant Medication, this ongoing safety review should not be a reason for parents to stop a child's stimulant medication or for any adult to stop their medicine without first speaking with their doctor.

If you or a child you care for take a stimulant medicine and you are concerned about this ongoing safety review, please follow up with your physician or other healthcare 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, you should contact your physician immediately.

Delay in Results From FDA's Ongoing Safety Review of Stimulant Medications used in Children with ADHD

The results of the ongoing studies sponsored by the U.S. Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ) to research potential serious heart-related risks associated with medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults has been delayed. The results of both studies are now expected in the early part of 2011. This delay is due to the challenges of collecting information and analyzing data from nearly 1.5 million patients. The FDA and AHRQ will continue their close contact with the study researchers and will provide updates once the study results are obtained and reviewed.

Stimulant products used to treat ADHD in children and adults 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.

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Source: FDA
Publication Date: 2010-08-05
Last Updated: 2010-08-06
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