FDA Proposes Withdrawal of Generic Concerta Over Concerns About Bioavailability

On November 4, 2016, the FDA announced that it is proposing withdrawal of approval of certain generics of Concerta (methylphenidate extended release) due to concerns about bioequivalence.    This applies only to the generics made by Mallinckrodt and Kudco, not the one made by Actavis.

Starting shortly after these generics entered the market, the FDA began to receive reports that the generics were ineffective.  This is not unusual, but the numbers of patients lodging complaints was much higher than expected, which triggered an investigation.   At that time, the FDA asked the companies to prove that their drugs were bioequivalent to brand Concerta or withdraw the drugs from the market.   Two studies were commissioned by the FDA.  One, in healthy adults, has been completed and demonstrated that the Mallinckrodt product did not demonstrate bioequivalence under newer FDA standards, and that the release rate of the drug was slower than the brand name equivalent.  This could explain why the drug was not working for some patients.  It's possible that it could have caused other issues as well, such as increased loss of appetite or insomnia.  Another study, in children with ADHD, is still ongoing.

Where does that leave us?  The FDA has allowed pharmacies to dispense generic Concerta while proceedings to withdraw the drugs from the market are ongoing, however, they have encouraged pharamacies not to substitute Mallinckrodt or Kudco generics for brand Concerta.

If you are taking one of the generics being investigated, rest assured that the only issue is bioequivalence/effectiveness compared to brand name Concerta.   There are no other safety issues with these generics.  However, since these drugs are likely to soon to be pulled from the market, you should make an appointment to discuss which medication and dose you will switch to.

If you are taking brand name Concerta or the Actavis brand, just make sure you keep getting the same generic.  You should be fine as the Actavis brand is identical to brand name Concerta.

It's too soon to know for sure if prices will rise, however, users of Concerta or its generics should be prepared for another round of shortages.