Short Description:FDA Notice: Be Wary of Some Generic Versions of Concerta
Whether generics are really therapeutically equivalent to branded versions of drugs has long been controversial. The US Food and Drug Administration (FDA) requires that generic companies demonstrate “bioequivalence” before they can be marketed, although these studies are conducted with healthy volunteers. Nonetheless, most of our patients are taking generics, and we hardly ever hear complaints.
Rarely, the FDA itself flags problems with generics—as they recently did regarding two generic versions of Concerta (methylphenidate extended-release) (http://1.usa.gov/11VqUyF). The FDA’s action came after it re-examined previously submitted data for the three generic versions of Concerta currently on the market. They found that the generic versions manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland delivered methylphenidate (MPH) at a slower rate over 10 to 12 hours than branded Concerta. Only Janssen Pharmaceutical’s generic version (marketed as Actavis) released MPH at the same rate.
The FDA’s action included downgrading the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. That means these two generics are still approved for use and can be prescribed, but are no longer recommended as automatic substitutes for Concerta.
What this means for prescribers depends on the scenario. Scenario A: Your patient is on one of the slow versions of Concerta and is doing perfectly well—no change needed. Scenario B: Your patient is on a slow generic and isn’t doing well—switch to Concerta or Activis. Scenario C: You are newly starting a patient on Concerta, or switching from brand to generic—specify on your script that you want it to be filled with Activis.
By the way, the FDA told Mallinckrodt and Kudco Ireland in November to fix their products within six months or to voluntarily withdraw them from the market. We’ll keep you apprised.
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