DPP-4 Inhibitors for Diabetes Can Cause Severe Joint Pain, FDA Says

August 28, 2015

Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause joint pain so intense it is disabling, the US Food and Drug Administration (FDA) warned today.

Fortunately, the pain goes away, usually in less than a month, once patients stop taking the medicine.

The agency said it identified 33 cases of severe arthralgia associated with DPP-4 inhibitors from October 16, 2006, through December 31, 2013, in its FDA Adverse Event Reporting System database. Twenty-eight of the cases involved sitagliptin (Januvia, Merck & Co, Inc). Sitagliptin accounts for more than 80% of all DPP-4 prescriptions in the country, according to a spokesperson for Merck.

Saxagliptin (Onglyza, AstraZeneca), linagliptin (Tradjenta, Boehringer Ingelheim Pharmaceuticals), alogliptin (Nesina, Takeda Pharmaceutical Company), and vildagliptin, which is not marketed in the United States, accounted for the rest of the 33 cases.

Patients began experiencing joint pain anywhere from 1 day to years after they started taking the drugs. For 10 patients, disabling pain required hospitalization.

Clinicians prescribe DPP-4 inhibitors in conjunction with diet and exercise to reduce blood sugar levels in patients with type 2 diabetes. They are either combined with other diabetes drugs such as metformin or dispensed as stand-alone products.

More information about today's announcement is available on the FDA website.

To report problems with DPP-4 inhibitors, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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