http://www.news.com.au/story/0,23599,20212249-1702,00.html SEVERAL drugs to treat attention deficit hyperactivity disorder, including the widely prescribed Ritalin, must include warning information about the risk of heart problems and psychotic behavior, US health officials said today.
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 said.
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.
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Strattera already includes a caution about suicidal thoughts, while Shire Plc's Adderall already carries a warning that misuse can cause heart problems.
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 - a so-called black box.