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New warning language has been added to all stimulant drugs, including Ritalin, Adderall, Dexedrine, and Concerta, the New York Times reports.
The drugs are used for the treatment of attention-deficit hyperactivity disorder and narcolepsy. The revised prescribing information warns, among other things, that "sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems."
Another new passage of the warnings section deals with potential psychiatric adverse events, such as the exacerbation of pre-existing psychotic disorder and induction of a mixed/manic episode in ADHD patients with bipolar disorder.
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Link: Dexedrine updated prescribing information (Free PDF)
Link: Letter on Dexedrine to healthcare providers (Free PDF)
Link: New York Times story (One-time registration required)