Generic Versions of ADHD Drug Concerta Not Therapeutically Equivalent

By Kelly Young

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

Certain generic versions of the attention-deficit/hyperactivity disorder drug Concerta (methylphenidate hydrochloride extended-release tablets) may not be therapeutically equivalent to the brand-name version, the FDA cautioned on Thursday.

The agency has not identified specific safety issues with the generics (made by Mallinckrodt or Kudco), and patients are instructed to continue treatment unless they notice a lack of effect. In that case, patients should contact their healthcare provider to see whether it may be appropriate to switch drugs.

The approved extended-release tablets are designed to be released over 10 to 12 hours, but in some patients the affected generics may be released at a slower rate, which could lead to a diminished effect.