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.