New Warnings on ADHD
By Susan Heavey
Mon Aug 21, 2006
WASHINGTON (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 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
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
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
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
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