FDA Panel Wants Suicide Risk on Novartis AG (NVS) ADHD Drug Label
1/31/2012 8:11:18 AM
Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S. pediatric health advisers said on Monday. Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older. The FDA often follows the advice of its committees, although it is not required to.
comments powered by