ADHD Drugs Linked to Sudden Death in Kids

Posted by Andy Alt on June 17, 2009

A couple of items regarding ADHD Drugs and links to more resources:

US News and World Report: ADHD Drugs Linked to Sudden Death in Kids

MONDAY, June 15 (HealthDay News) — Stimulant medications commonly prescribed to treat attention-deficit hyperactivity disorder (ADHD) are associated with an increased risk of sudden death, but those deaths are still rare, new research finds.

Children and teens taking ADHD stimulant medications were seven times more likely to die suddenly than their peers, the study found.

“What we found — to our surprise — is that even if you take out confounding factors, the association between stimulant use and sudden death was still significant,” said study author, Madelyn Gould, a professor of clinical epidemiology in psychiatry at Columbia University/New York State Psychiatric Institute in New York City. “I’m confident the association is real and significant, but it’s very rare. I don’t want our findings to change prescribing patterns or for a parent to change their willingness to use stimulant medications if they’re called for, but physicians should monitor patients with any new medication you give a young person.”
[...] The complete story is at http://health.usnews.com/articles/health/healthday/2009/06/15/adhd–drugs-linked-to-sudden-death-in-kids.html

Food and Drug Administration (FDA): Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder – Communication about an Ongoing Safety Review
– June 15, 2009

Products involved 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.

Audience: Pediatricians, Neuropsychiatric healthcare professionals

[Posted 06/15/2009] FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, 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 a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. 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.

[06/15/2009 - Communication About An Ongoing Safety Review - FDA]
[06/15/2009 - News Release - FDA]
[06/15/2009 - Stimulant Medications Prescribing Information, Medication Guides - FDA]