Medication Information That May Be of Interest for Pediatric Hospitals, as Well as Pediatric and Cardiology Departments
MedSun: Newsletter #7, September 2006

FDA and GlaxoSmithKline notified health care 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.

Read the complete MedWatch 2006 Safety summary, including links to the manufacturer's letter to health care professionals and the product's approved labeling, see Additional Information below.

Additional Information:

MedWatch 2006 Safety summaries
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150332.htm


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