DPP-4 inhibitors may cause severe joint pain

September 2, 2015

FDA issued a warning this week that dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause severe and disabling joint pain.

FDA issued a warning this week that dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause severe and disabling joint pain.

The FDA said that sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), and alogliptin (Nesina) may cause joint pain, and the labels of these DPP-4 inhibitors have been revised to include this risk. The DPP-4 inhibitors are indicated for adults with type 2 diabetes, to be used with diet and exercise to lower blood sugar levels. These drug are used as single ingredient products or in combination with other drugs such as metformin.

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After a search of its Adverse Event Reporting System (FAERS) database and the medical literature, FDA identified 33 cases of severe joint pain associated with the use of DPP-4 inhibitors, the agency said in its Drug Safety Communication.  Ten of these patients required hospitalization due to disabling joint pain. In 20 cases of arthralgia, the DPP-4 inhibitor was stopped within the first month of the onset of symptoms. In eight of the 13 other cases, patients were treated for 44 days to a year before stopping DPP-4 inhibitor therapy. In most of the cases, patients’ symptoms resolved within a month after drug discontinuation.

Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their healthcare professional right away if they experience severe and persistent joint pain. “Healthcare professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate,” the FDA wrote.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of DPP-4 inhibitors to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.

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