Second FDA group advises against ADHD warnings

April 10, 2006

After reviewing data on ADHD drugs and their propensity to cause psychosis, mania, aggression, or cardiovascular side effects in children, the FDA's Pediatric Advisory Committee told the agency that black box warnings are not necessary, but rather warnings should be rewritten in a language that is better understood. This decision follows a recommendation in February from the agency's Drug Safety & Risk Management Advisory Committee to add the strongest possible warning regarding cardiovascular risk.

Second FDA group advises against ADHD warnings

After reviewing data on ADHD drugs and their propensity to cause psychosis, mania, aggression, or cardiovascular side effects in children, the FDA's Pediatric Advisory Committee told the agency that black box warnings are not necessary, but rather warnings should be rewritten in a language that is better understood. This decision follows a recommendation in February from the agency's Drug Safety & Risk Management Advisory Committee to add the strongest possible warning regarding cardiovascular risk. Robert Temple, M.D., director of the FDA's Office of Medical Policy, said that the pediatric committee was not impressed with the overall cardiovascular risk in children and it suggests a distinction be made in the labeling between the risk for children with known or suspected heart disease and seemingly healthy children. Robert Nelson, M.D., the committee chair, said it is less important to have black box warnings now in light of the new labeling format that will go into effect in June 2006. He said that all important warnings in the revised label will be right up front on a new half-page highlighted area that serves the same purpose as a black box. The committee also suggested an FDA-approved medication guide be distributed to patients and caregivers that describes early warning signs of potential serious side effects and encourages them to contact their physician should they occur. The FDA has not made a final decision as to whether it will accept or reject either committee's recommendations.

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