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Glaxo Adds Strong Heart Risk Warning to ADHD Drug
BETHESDA, M.D. -- August 21, 2006 -- The US Food and Drug Administration (FDA) and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
[August 04, 2006 - Letter – GlaxoSmithKline http://www.fda.gov/medwatch/safety/2006/Dexedrine_DHCP_Letter.pdf]
[June 2006 - Label – GlaxoSmithKline http://www.fda.gov/medwatch/safety/2006/Dexedrine_PI.pdf]
SOURCE: Food and Drug Administration
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