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FDA to Warn on
J&J's Concerta Drug
From Bloomberg News
June 29, 2005
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.
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