Most attention deficit hyperactivity disorder drugs should include new warnings about the risk of psychotic behavior, heart problems and sudden death, according to U.S. health officials on Monday.
These drugs include Novartis AG's Ritalin and GlaxoSmithKline Plc's, Dexedrine, Food and Drug Administration spokeswoman, Susan Bro said.
She said that these stimulant drugs, stimulants can raise blood pressure. They must also include warnings about the risk of behavioral problems such as aggression and mania.
Bro was not able to confirm whether other ADHD drugs -- Eli Lilly and Co.'s Strattera and Johnson & Johnson's Concerta were also ordered to carry the warnings.
Strattera already includes a warning about suicidal thoughts, while Shire Plc's Adderall already carries a warning that misuse can cause heart problems.
The FDA's decision follows months after conflicting opinions were offered by two separate panels of outside experts on whether the risks warranted the need for the 'black box', the strongest warnings possible.
Although Bro could not confirm whether the heart warning was boxed, a letter from Glaxo said the heart caution was a boxed warning. In addition other non-boxed warnings such as psychotic behavior, stunted growth, seizures and vision problems were also included.
Glaxo is also reported to have agreed with the FDA's request to add the warning language, compiling with the agency's recommended wording.
Concerns whether the new warnings could dampen use of the medicines was expressed by several doctors. The FDA has estimated that presently about 1 million prescriptions for adults and 2 million for children are seen each month. The necessity of many of these prescriptions is still under question with critics pointing out that the drugs are over used.
In May, Canadian health authorities publicly warned people with high blood pressure, heart disease and other medical problems to avoid taking medications for ADHD.