Black-Box Warning Added to Dexedrine

Deborah Flapan


August 24, 2006

August 24, 2006 — The US Food and Drug Administration and GlaxoSmithKline (GSK) have notified healthcare professionals by letter of labeling changes to dextroamphetamine sulfate (Dexedrine), which has been associated with sudden death when administered at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems, according to an alert from MedWatch, the US Food and Drug Administration's (FDA's) safety information and adverse event reporting program.

Dexedrine is approved for the treatment of attention deficit–hyperactivity disorder (ADHD) and narcolepsy.

According to the company's letter, GSK made the labeling changes in response to an FDA request sent to all manufacturers of all central nervous system (CNS)–stimulating drugs approved for the treatment of ADHD. The agency asked for "additional, standardized language in prescribing information based on the recommendations made by members of two different advisory committees that convened earlier this year."

The following text has been added as a boxed warning to the beginning of the dextroamphetamine prescribing information: "Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events."

Under the Warnings section of the drug labeling, the following conditions are listed that place children and adolescents at risk for sudden death while receiving dextroamphetamine: "serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug."

In the letter, GSK encourages healthcare professionals to report adverse events linked to use of dextroamphetamine to the company at 1-888-825-5249.

In addition, healthcare professionals are encouraged to report adverse events related to use of dextroamphetamine and other CNS stimulants to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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