Medical experts are seeking new label warnings for Focalin (dexmethylphenidate), a drug used to treat children with attention deficit hyperactivity disorder (ADHD), regarding possible occurrences of suicidal thoughts.
According to a Reuters report, several members of a U.S. Food & Drug Administration (FDA) advisory committee asked for the label change recently, citing eight reports of suicidal thoughts in children treated with Focalin over the past six years.
The FDA said it did in fact receive 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.
Focalin is a mild stimulant to the central nervous system, and a modified version of Ritalin. It is made by Swiss drugmaker Novartis AG. It is approved for children aged 6 or older.
To continue reading Medical Experts Want Suicide Warning On ADHD Drug Focalin Label
