WASHINGTON – Several drugs to treat attention deficit hyperactivity disorder must include new warning information about the risk of heart problems and psychotic behavior, U.S. health officials said on Monday.
The drugs, which include GlaxoSmithKline Plc’s Dexedrine and Novartis AG’s Ritalin, must include a warning about the possible risk of sudden death and serious heart problems, Food and Drug Administration spokeswoman Susan Bro told Reuters.
The drugs, stimulants that can raise blood pressure, must also include warnings about the risk of behavioral problems such as aggression and mania, she said.
Bro could not confirm whether other ADHD drugs â Johnson & Johnson’s Concerta and Eli Lilly and Co.’s Strattera â also were ordered to carry the warnings.
Strattera already includes a caution about suicidal thoughts, while Shire Plc’s Adderall already carries a warning that misuse can cause heart problems.
Conflicting opinions
The FDA’s decision comes months after two separate panels of outside experts offered conflicting opinions on whether the risks warranted the strongest warnings possible â a so-called black box.
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