Tuesday, November 18, 2014

Important Information on Generic Versions of Concerta

by Ruth Hughes, PhD

If you, or those under your care, are taking a generic version of Concerta (methylphenidate hydrochloride extended release tablets), be aware that the Food and Drug Administration has some concerns about their bioequivalency—their effectiveness. After receiving numerous complaints about the generic versions made by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd., the FDA has given both companies six months to demonstrate their products’ bioequivalency to Concerta or withdraw them from the market.

The FDA has not identified any serious safety concerns with these generic brands. They are not suggesting you make changes to your treatment (or your child’s treatment) unless you consult with your health care provider. The FDA has not expressed concerns regarding the generic brands (methylphenidate hydrochloride EX) manufactured by Actavis or Janssen.

So what does this mean for you? If someone in your family is currently taking a generic version of Concerta, CHADD recommends that you:

1.    Check with your pharmacist and find out what company is manufacturing your medication.
2.    Share the FDA alert with your pharmacist.
3.    Consult with your health care provider if you are concerned about the effectiveness of your medication, or have any other concerns about its use.
4.    If you and your health care provider determine that it would be best for you to change your prescription for name brand Concerta, be certain to ask if your insurance plan covers this cost.
5.    If it doesn’t, ask your health care provider to contact your insurance company and request an exception from any restrictions requiring generic medications for ADHD.

We will keep you informed on this issue.

Ruth Hughes, PhD, is the former CEO of CHADD. A clinical psychologist by training, she has an adult son with ADHD who is thriving. A former member of CHADD's national board of directors, she served as both Deputy CEO and Chief Program Officer before becoming CEO, and now serves as a special advisor.