US FDA calls for new warnings on ADHD drugs

[Guest guest]

[This was common knowledge 30 years ago. The reasons the FDA has acted is

because of the current lack of public trust, and the scrutiny it must now

endure.--]

US FDA calls for new warnings on ADHD drugs

By Heavey

August 22, 2006 10:16am

Article from: Reuters

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 GlaxoKline 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 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 - & '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 , 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.

Regards,

Do not follow where the path may lead;

go instead where there is no path and

leave a trail.