According to the analysis of the agency, the two generic versions deliver the drug in the body at a slower rate. When the delivery is at a slower rate, the agency said it means it is less effective.
According to Dr. Andrew Adesman, chief of developmental & behavioral pediatrics at Cohen Children's Medical Center of New York, in New Hyde Park, 'With this recent announcement, the FDA appears to be acknowledging a mistake that it made in recognizing [these] two formulations of methylphenidate as generic equivalents to Concerta.'
Dr. Deepan Singh on the other hand said that the problem is known among clinicians. He is a child, adolescent and adult psychiatrist at Winthrop-University Hospital in Mineola, N.Y
'I have made it a practice to show photographs of the original Concerta and its 'true' generic version to patients and families to ensure that the patients get the full and expected effectiveness of the medication,' Singh added.
The Food and Drug Administration said that the two generic versions of Concerta can still be prescribed yet it is no longer recommended as an alternative. Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. Were given six months to prove the defectiveness of their drug.
The agency further said that there are no serious safety concerns associated with the generic versions of Concerta. If patients are taking them, they are advised to consult their doctors first before making any changes on their medications.
Janssen Pharmaceuticals Inc. is the manufacturer of Concerta. It also manufactured a generic version of Concerta, which is marketed by Actavis.
