news on concerta | ADHD Information

Has anyone any information about Concerta?  I saw an article in the newspaper about new possible side effects from Concerta. It mentioned something about psychiatric side effects.  Does anyone know any more detailed info. Thanks
From the Los Angeles Times:

Johnson & Johnson's Concerta attention-deficit disorder drug users have
had hallucinations, psychotic behavior, suicidal thoughts and heart
complications such as high blood pressure, U.S. regulators said.

The Food and Drug Administration is considering how best to tell doctors
and consumers about these complications, the agency said in a statement
posted Tuesday on its website.


A panel of FDA advisors will discuss Concerta's potential complications at
a meeting Thursday in Rockville, Md.

Concerta, a once-daily form of Novartis' Ritalin, is the most prescribed
drug for attention-deficit-hyperactivity disorder, or ADHD, according to a
Johnson & Johnson website. The FDA said last year that it had Shire
Pharmaceuticals Group give doctors warnings about sudden
cardiovascular death linked to its Adderall drug for the same disorder.

"The FDA is pursuing additional means to better characterize the
cardiovascular risks for all drug products approved for ADHD," the agency
said in its statement.

"Potential options under consideration include population-based
pharmaco-epidemiologic studies, long-term safety trials and other
targeted CV risk studies."

Canadian health officials in February ordered Shire to withdraw Adderall,
also an amphetamine, because it was linked to at least 20 deaths.

Attention deficit disorder affects about 4.1% of people ages 9 to 17 in any
given six-month period, according to the National Institutes of Health's
website.

Johnson & Johnson will not discuss the FDA's statement ahead of the
meeting, said Kathy Fallon, a company spokeswoman.

"It would be inappropriate for us to comment at this point, as we have not
seen the complete FDA presentation," Fallon said.

The FDA said it would add details to the Concerta label about the
psychiatric complications.