Dexedrine (dextroamphetamine sulfate)
Audience: Psychiatrists, pediatricians, mental healthcare professionals, pharmacists and consumers[Posted 08/21/2006] The 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]
[June 2006 - Label - GlaxoSmithKline]