FDA: Two Generic Versions of ADHD Drug Not As Effective
In some patients, the medications were released more slowly than extended-release Concerta
FRIDAY, Nov. 14, 2014 (HealthDay News) -- Two generic versions of the attention-deficit/hyperactivity disorder drug Concerta may not work as effectively as the brand-name product does, the U.S. Food and Drug Administration said Thursday.
The agency analyzed available data and conducted laboratory tests on the two generic versions of Concerta (methylphenidate hydrochloride extended-release tablets) made by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd.
The generic versions were approved by the FDA on the basis that they released the drug in the body over a period of 10 to 12 hours, to achieve the same effect as a three-times-per-day dose of immediate-release methylphenidate hydrochloride. But in some patients, the two generic versions may deliver the drug in the body at a slower rate. This slower release rate means the drug may be less effective, the FDA warned. Experts said the warning is warranted.
While the two other generic versions are still approved and can be prescribed, they are no longer recommended as suitable alternatives for Concerta, the FDA said. The agency has given Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. six months to confirm the effectiveness of their products or withdraw them from the market. There are no serious safety concerns associated with these two generic versions of Concerta, and patients should not make changes in their drug treatment before consulting with their doctor.
Concerta is manufactured by Janssen Pharmaceuticals Inc., which also makes a generic version of the drug marketed by Actavis. It is identical to Concerta, the FDA said.