August 28, 2015 — The U.S. Food and Drug Administration (FDA) has issued a Safety Communication about the risk of severe, disabling joint pain from type-2 diabetes medications in the dipeptidyl peptidase-4 (DPP-4) inhibitor class.
The warning was issued after a search of the FDA adverse event database identified 33 cases of severe joint pain associated with DPP-4 inhibitors. It is likely that many more cases were never reported.
Nearly all of the reports involved patients on Januvia (sitagliptin), the most popular DPP-4 inhibitor. Januvia was approved in October 2006 and was the first drug in its class. It is made by Merck & Co. and raked in nearly $2 billion in sales in the first part of 2015, despite concerns about pancreatic cancer.
The FDA warned that some patients developed joint pain in as little as one day, with 22 cases occurring in the first month of starting the drug. In some cases, symptoms did not appear for up to one year after initiating treatment.
The joint pain was also very severe in many cases. Ten patients had to be hospitalized due to severe pain. Fortunately, most patients got better after stopping the medication. Eight patients who re-started a DPP-4 inhibitor experienced recurrent joint pain.
The FDA recommends:
Contact your health care professional right away if you develop severe and persistent joint pain while taking one of these medicines. Do not stop taking your DPP-4 inhibitor medicine without first talking to your health care professional.
DPP-4 diabetes medications include:
- Januvia (sitagliptin)
- Janumet (sitagliptin and metformin)
- Janumet XR (sitagliptin and metformin extended release)
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin extended release)
- Glyxambi (linagliptin and empagliflozin)
- Jentadueto (linagliptin and metformin)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
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