FDA calls for new warnings on ADHD drugs

Aug 21, 2006

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 — Johnson & Johnson's Concerta and Eli Lilly and Co.'s Strattera — 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 — a so-called black box.

FDA's Bro could not confirm whether the heart warning was boxed. But a letter from Glaxo made public earlier on Monday advising doctors about the new warnings said the heart caution was a boxed warning.

Other non-boxed warnings about psychotic behavior, stunted growth, seizures and vision problems also were included, Glaxo's letter said.

Holly Russell, spokeswoman for the British drugmaker, said Glaxo agreed with the FDA's request to add the warning language and complied with the agency's recommended wording.

Other drugmakers did not immediately return calls seeking comment.

In March, FDA advisers said new information about the risks should be added to the labels for attention deficit drugs. The outside experts stopped short of supporting a boxed warning, saying they did not want to scare off patients or their parents.

A different FDA panel in February recommended black box heart-related warnings but said it was unclear if the drugs caused heart-related complications.

Doctors worried warnings could hinder use
Some doctors have expressed concern that new warnings could dampen use of the medicines, which the FDA has estimated see about 1 million prescriptions for adults and 2 million for children each month.

Critics say many of the prescriptions are unnecessary and that the drugs are over used.

FDA's Bro said the agency began contacting Glaxo and Novartis about the new warning requirements in May.

That same month, Canadian health authorities publicly warned people with high blood pressure, heart disease and other medical problems to avoid taking medications for ADHD.

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