Experts want suicide risk warning on ADHD drug

The American Food and Drug Administration (FDA) has been advised by one of its advisory committees to change the label on the Swiss-made drug Focalin to add a warning that ingesting the drug may cause suicidal thoughts.

Focalin is prescribed to children of 6 years old and up for attention deficit disorder, and the FDA says it has received eight reports of suicidal thoughts from children and adolescents who took the drug over six years. Four of these cases appeared to be linked to the medicine.

However, the head of the FDA’s psychiatric products division, Tom Laughren, says that the risk of suicidal thoughts did not appear in the clinical trails for Focalin, and that these reports are merely a handful whose causality is difficult to determine. The drugs are very widely used, and ADHD is a disease that has increased very quickly in number over recent years, with between 3 and 5% of children now affected around the world.

Source: Reuters

First published in January 2011

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