An advisory committee to theFDA 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.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.
The FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.
Focalin is used to treat attention deficit hyperactivity disorder (ADHD). Symptoms of attention deficit disorders include continual problems with moderate to severe distractibility, short attention span, hyperactivity, emotional changeability, and impulsiveness. Focalin should be given as part of a total treatment program that includes psychological, educational, and social measures.