FDA Issues Severe, Persistent Joint Pain Warning for DPP-4 Inhibitors
Severe, Persistent Joint Pain Warning Issued for Diabetes Drug Class
The US Food and Drug Administration is warning that use of dipeptidyl peptidase-4 inhibitors may cause joint pain, which may be severe and disabling. DPP-4 inhibitors are a class of drugs used as adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes.
The FDA reported cases of severe joint pain in patients using DPP-4 inhibitors through a search of the FDA Adverse Events Reporting System (FAERS) database and medical literature. Symptoms appeared from one day to years after patients started DPP-4 inhibitor therapy.
Patients' symptoms were relieved after discontinuing the drug within a month. However, some patients experienced severe joint pain again when they restarted the same drug or another DPP-4 inhibitor.
A new "Warning and Precaution" has been added to the drug labels of all drugs in this class. The FDA recommends that patients do not stop their DPP-4 inhibitor therapy but contact their healthcare professional immediately if they experience severe and persistent joint pain.Affected products include:
- Alogliptin and metformin
- Alogliptin and pioglitazone
- Linagliptin and empagliflozin
- Linagliptin and metformin
- Saxagliptin and metformin extended-release
- Sitagliptin and metformin
- Sitagliptin and metformin extended-release