New warnings on ADHD drugs

Susan Heavey, "New warnings on ADHD drugs", Reuters UK, August 22,
2006,
Link:
http://today.reuters.co.uk/news/arti...ESSANTS-DC.XML

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.

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.