GSK WARNS OF SUDDEN-DEATH RISK WITH ADHD DRUG

GlaxoSmithKline (GSK) has revised the prescribing information for its attention-deficit/hyperactivity disorder (ADHD) drug Dexedrine to indicate that the drug can cause sudden death in patients with heart abnormalities.

The company said it made the changes in response to the recommendations of members of two FDA advisory panels.

GSK's revisions, posted Aug. 21, include a notice that "misuse of amphetamines may cause sudden death and serious cardiovascular adverse events." The new label also details the possible threat of psychotic and cardiovascular risks in patients, including psychosis, mania and aggression in children taking this class of drugs, as well as possible cardiovascular risks in juvenile and adult patients with pre-existing heart conditions.

Dexedrine (dextroamphetamine sulfate) is approved for the treatment of ADHD and narcolepsy.