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Accept No Substitutes 

Q: My son takes extended-release methylphenidate once daily for his ADHD. I recently heard that there were concerns about this medication when the generic is used. Should I be worried?

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A: Yes. In November 2014, the FDA issued a warning about generic extended-release methylphenidate. When methylphenidate (initial brand name Ritalin) was first used, it needed to be administered three times daily because its effects wore off quickly. To circumvent this, a very effective extended release formula was developed — Concerta, by Janssen Pharmaceuticals, which allowed patients to take the medication once daily. This was an advance, as it allowed, for example, students to go to school all day without having to take medication while at school. Eventually, generic and cheaper versions of this extended-release methylphenidate medication were approved and marketed. Later, the FDA began to receive reports of problems, and upon analyzing the medications determined that two of the generic brands (manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Limited) may deliver the medication to the body at a slower rate, seven to 12 hours after it is taken. One generic brand also manufactured by Janssen, but marketed by a company called Actavis, was found not to have problems. At this point, the FDA has changed the ratings for the Mallinckrodt and Kudco brand generics, and they should no longer be substituted for Concerta. If your son is being treated with extended-release methylphenidate, he should be receiving either Concerta or the generic from Actavis. Talk to your pharmacist about this if you are unsure. They will see that you get an appropriate, effective brand.


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