FDA looking into generic long-acting methylphenidates and variable effect

FDA looking into generic long-acting methylphenidates and variable effect

The following post from the FDA appeared today about complaints that generic long-acting methylphenidates (brand name-Concerta) may not work equally well.

“In the case of the ADHD drug — certain generic versions of methylphenidate hydrochloride  (Concerta, Janssen Pharmaceuticals) — the issue is a possible lack of therapeutic effect, which may be linked to product quality issues, according to the FDA.

A drug’s appearance on the list, which grows quarter by quarter, does not mean the FDA has concluded that the drug actually poses the health risk reported through FAERS. Instead, the agency is studying whether there is indeed a causal link. If it establishes one, the FDA then would consider a regulatory response such as gathering more information to better describe the risk, changing the drug’s label, or mandating a risk evaluation and mitigation strategy.”

If you have followed my blogs, I wrote about this in January 2014, as patients were mentioning that “my medicine isn’t working any more.” So, what to do?

Turns out that Watson Pharmaceutical makes generic Concerta with the original OROS technology that delivers methylphenidate in a very specific fashion. Mallinkrodt Pharmaceutical makes the generic Concerta without the OROS technology. The reason the FDA originally approved this generic was that it shown to be “bioequivalent” on a pharmacokinetic chart. How can you tell the difference? The OROS pill is barrel shaped, Mallinkrodt is a “flatten oblong” pill. IF you receive your medication from mail order, this will help you identify what pill you’re getting. If in doubt, call the mail order pharmacy and ask specifically about brand of generic.

What to do? I have been advising my patients on generic Concerta who are complaining about diminish effect to change to the Watson brand. This change may not be needed if the Mallinkrodt brand works for you. If not, the your doctor needs to write Watson brand specifically on your prescription.

But where to find it? As of this posting, Walgreen’s dispenses the Watson brand and Target and CVS dispense the Mallinkrodt brand. This is because they have different medication distributors. Who would have know?

So, what to do? If your medication is working, the brand of generic Concerta doesn’t matter. If your generic Concerta was working and has “lost its effect”, check the manufacture. If you were changed to Mallinkrodt, and you were better with the “barrel” shape pill, go back to Watson brand. Don’t simply conclude that generic Concerta doesn’t work. Unfortunately that is likely to happen to new patients started on generic Concerta who get the Mallinkrodt brand.

Hope this insight is helpful.