Focalin and Suicidal Thoughts

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Wed, 02/01/2012

Members of an FDA advisory committee have recommended that the label for Focalin be changed to reflect a risk of suicidal thoughts.  Focalin, made by Swiss drug manufacturer Novartis AG, is a drug commonly taken by some children for attention deficit disorder.

 
The FDA has said they received eight reports of suicidal thoughts associated with use of the drug, and four of the cases have been linked to the medicine.  1.8 million children received prescriptions for Focalin from May 2005 to July 2011, including its generic versions.
 
At present, the label for Focalin warns of psychotic or manic symptoms, but does not include language regarding suicidal thoughts.  Experts are split as to whether the 8 reports represent a significant problem with the drug.
 
 
 
 
 
 

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