Several drugs to treat attention deficit hyperactivity disorder must include new warning information about the risk of heart problems and psychotic behavior, the FDA has said, The drugs, which include GlaxoSmithKline’s Dexedrine and Novartis’ Ritalin, must carry a warning about the possible risk of sudden death and serious cardiac problems, and of behavioural problems such as aggression and mania.
The FDA’s decision comes months after two expert panels offered conflicting opinions on whether the risks warranted the strongest warnings possible - a so-called ‘black box’.
However, a letter from GSK made public advising doctors about the new warnings said the cardiac caution was a boxed warning.
Other non-boxed warnings about psychotic behavior, stunted growth, seizures and vision problems also were included, GSK’s letter said.
An estimated 3 million ADHD prescriptions are issued in the US each month.
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