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FDA Warning for DPP-4 Diabetes Drugs and Joint Pain

FDA Warning for DPP-4 Diabetes Drugs and Joint Pain

August 28, 2015 — The FDA is warning that type-2 diabetes drugs in the DPP-4 inhibitor class can cause severe, disabling joint pain.

The warning was issued after a search of the FDA adverse event database and medical literature identified 33 cases of severe joint pain associated with dipeptidyl peptidase-4 (DPP-4) inhibitors since October 2006. Because many adverse events are never reported, it is possible the actual number of cases is much higher.

All but five of those cases involved Januvia (sitagliptin), the most popular DPP-4 inhibitor and the first to gain approval from the FDA. Januvia is currently the best-selling drug from Merck & Co., despite a growing number of lawsuits involving pancreatic cancer.

Ten patients were hospitalized due to disabling joint pain. About two-thirds of patients experienced symptoms of joint pain within one month of starting treatment, but in some cases symptoms did not appear for up to one year.

In most cases, joint pain improved within a month of discontinuing the medication. Several patients experienced recurrent joint when they re-started the same drug. In five cases, the patient experienced severe joint pain with two different DPP-4 inhibitors.

Diabetes medications in the DPP-4 inhibitor class include:

FDA Recommendation

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.

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