Concerta™ (methylphenidate hydrochloride): New Warning on Priapism

Janssen would like to alert healthcare professionals to the potential risk of priapism associated with Concerta^™ (methylphenidate hydrochloride). Prolonged and painful erections (priapism) requiring immediate medical attention (sometimes requiring surgical intervention), have been reported in people taking methylphenidate-containing medicines, including Concerta^™. Cases of priapism have been observed in both paediatric and adult patients. These adverse events may not occur immediately with methylphenidate and can develop after some time, often following an increase in dose. Priapism has also occurred during periods of  methylphenidate withdrawal (e.g. during drug holidays or during discontinuation).  Patients should be instructed to seek medical attention if they develop abnormally sustained or frequent and painful erections. The package inserts for Concerta^™ will be updated to reflect the new safety information.