Medical experts are seeking new label warnings for Focalin (dexmethylphenidate), a drug used to treat children with 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 yesterday, citing eight reports of suicidal thoughts in children treated with Focalin over the past six years.
“The suicidal ideation seems to be pretty serious,” said Dr Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children’s Hospital.
According to Reuters, at least four reports of suicidal thoughts among Focalin patients appear to be directly linked with the drug. A link with four other reports was less clear.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011. According to Reuters, the drug’s label does bear warnings that psychotic or manic symptoms could be possible side effects, but nothing on suicidal thoughts.
The advisory committee also recommended changing Focalin’s label to reflect the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
Focalin is a mild stimulant to the central nervous system, and a modified version of Ritalin. It is used to treat used to treat ADHD in children over six.
According to Reuters, some 2.7 million people in the U.S. have prescriptions for ADHD drugs. Symptoms of attention deficit disorders include continual problems with moderate to severe distractibility, short attention span, hyperactivity, emotional changeability, and impulsiveness.
Of the ADHD drugs currently on the market, only one – Strattera – bears a label warning about sucidal thoughts as a possible side effect, Reuters said.