Saturday, August 29, 2015

Class-Wide DPP-4 Diabetes Med Effect: Joint Pain -- FDA Warns, On Friday


I'll note this almost solely to complete the record, here -- since we try to run down all material items related to Merck.

As we've previously indicated, in fairly short order, the SGLT-2 class will be supplanting the DPP-4 class as the oral diabetes med of first choice (beyond metformin -- a Merck drug, but now long generic). This FDA revision will likely hasten that coming switch-over, at least for prescribers with patients complaining of recurrent joint pains, along with their diabetes. Not good news, here in the US -- for Kenilworth -- but only a minor headwind near term, overall, for the behemoth that is Merck's annual revenue tide, rolling in. Here's the FDA press alert -- and the list of covered products:

. . . .The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.

Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. . . . [Affected DPP-4 class products]:

Januvia (sitagliptin), Janumet (sitagliptin and metformin), Janumet XR (sitagliptin and metformin extended release), Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Tradjenta (linagliptin), Glyxambi (linagliptin and empagliflozin Jentadueto (linagliptin and metformin), Nesina (alogliptin), Kazano (alogliptin and metformin), Oseni (alogliptin and pioglitazone). . . .


So it goes. . . . Meanwhile, our eyes will be on the night skies for a few evenings now. . . smilingly so, immortal and beloved. . . .

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