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UPDATE 2-US FDA calls for new warnings on ADHD drugs

Recasts, new throughout)

By Susan Heavey

WASHINGTON, Aug 21 (Reuters) - 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 (GSK.L: Quote, Profile,
Research) (GSK.N: Quote, Profile, Research) Dexedrine and Novartis AG's
(NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research)
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
(JNJ.N: Quote, Profile, Research) Concerta and Eli Lilly and Co.'s (LLY.N:
Quote, Profile, Research) Strattera -- also were ordered to carry the
warnings.

Strattera already includes a caution about suicidal thoughts, while Shire
Plc's (SHP.L: Quote, Profile, Research) 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.

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.

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.