A panel of pediatric experts has recommended that the FDA change the label for Focalin to address the risk of suicidal thoughts by children, according to Reuters.
The drug is prescribed for attention deficit disorder and is manufactured by Novartis AG. It was approved for children 6 and older in 2001.
Children with ADHD are excessively restless, impulsive, easily distracted and often have behavioral issues. Symptoms generally are relieved with behavioral therapy and medication (at least short term; the long term benefits of medication are less clear).
The FDA is not required to follow the advice of its panels, but usually does. It is required to hold regular advisory meetings to review the safety of drugs used by children. The panel also recommended that Focalin's label acknowledge the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
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