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Published on FierceBiotech (http://www.fiercebiotech.com)

Regulators ponder response to Concerta complications

By admin
Created Jun 28 2005 - 8:01pm

Faced by a host of disturbing complications linked to Johnson & Johnson's Concerta, regulators at the FDA are pondering the best way to alert providers. Regulators say that patients taking Concerta -- a once-daily form of Ritalin -- have experienced hallucinations, suicidal thoughts, high blood pressure and psychotic behavior, according to a report in the Los Angeles Times.

"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."

- read this article [1] from the Los Angeles Times


Source URL:
http://www.fiercebiotech.com/story/regulators-ponder-response-to-concerta-complications/2005-06-29