| Jan Drew 2006-08-27, 2:26 am |
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http://www.news.com.au/story/0,2359...49-1702,00.html
SEVERAL drugs to treat attention deficit hyperactivity disorder, including
the widely prescribed Ritalin, must include warning information about the
risk of heart problems and psychotic behavior, US health officials said
today.
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
said.
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.
Ms 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.
Ms Bro could not confirm whether the heart warning was boxed. But a letter
from Glaxo made public earlier today advising doctors about the new warnings
said the heart caution was a boxed warning.
Other non-boxed warnings about psychotic behaviour, 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 one million
prescriptions in the US for adults and two million for children each month.
Critics say many of the prescriptions are unnecessary and that the drugs are
over-used.
Ms 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
SEVERAL drugs to treat attention deficit hyperactivity disorder, including
the widely prescribed Ritalin, must include warning information about the
risk of heart problems and psychotic behavior, US health officials said
today.
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
said.
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.
Ms 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.
Ms Bro could not confirm whether the heart warning was boxed. But a letter
from Glaxo made public earlier today advising doctors about the new warnings
said the heart caution was a boxed warning.
Other non-boxed warnings about psychotic behaviour, 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 one million
prescriptions in the US for adults and two million for children each month.
Critics say many of the prescriptions are unnecessary and that the drugs are
over-used.
Ms 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
http://factsandcomparisons.com/News...ge.aspx?id=7350
FDA Orders Stronger Labeling for ADHD Drugs
8/24/2006
The New York Times reports that the FDA has ordered
stronger warning labels for attention deficit hyperactivity disorder drugs,
including Adderall, Concerta, Dexedrine, and Ritalin, to caution against
their use in adults and children with heart problems and to alert doctors
that the drugs can cause one child in a thousand to experience
hallucinations. The updated warnings come after some reports of sudden death
in children after taking the drugs; some of the children were later
determined to have had structural heart defects.
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