Focalin Suicide Warning Needed, FDA Experts Say

A committee of health experts have recommended that the ADHD drug Focalin carry a warning about the potential increased risk of suicide. 

A number of adverse event reports have been submitted to the FDA over the past six years, indicating that a number of children given Focalin have experienced suicidal thoughts that could be linked to the Novartis drug.

Last week, an FDA advisory committee said that concerns over the risk of suicide from Focalin side effects probably merit a new warning.

In 2009, one 7 year old boy hung himself after being put on a regimen of Focalin for treatment of attention-deficit/hyperactivity disorder (ADHD), but the incident has never been conclusively linked to the drug. However, there have been a number of reports of suicidal thoughts by children taking Focalin, who did not have such thoughts before taking the drug. This has led some experts on the advisory committee to call for a revised label warning.

The findings of the FDA’s advisory committees are not binding. However, the agency tends to strongly weigh the committees’ recommendations when considering any regulatory action.

FDA investigators indentified eight adverse event reports involving Focalin suicidal thoughts among children in a report sent to the Pediatric Advisory Committee before its January 30-31 hearing. In four of those cases, the suicidal thoughts stopped after they were taken off Focalin. In one case, the thoughts stopped even though Focalin treatment continued. There was no follow-up data on the remaining three adverse events.

Focalin (dexmethylphenidate) is a pill approved for the treatment of ADHD in patients ages six to 17 years old. It was approved by the FDA in 2001.

There have been three reports of child deaths linked to Focalin, but only one involved suicide. Other reported psychological side effects reported to the FDA’s adverse event reporting system included hallucinations, depression and violent thoughts, according to the FDA’s staff report.