The FDA issues warning about type 2 diabetes drugs and joint pain, stating that the pain may be severe and disabling. The drugs included in the warning are all from the drug class dipeptidyl peptidase-4 (DPP-4) inhibitors. The risk is serious enough that the FDA added a new “Warning and Precaution” to the labels of all drugs in this class. These include sitagliptin, saxagliptin, linagliptin, and alogliptin.DPP-4 inhibitors are oral medications used in conjunction with diet and exercise to lower blood sugar levels in adults living with type 2 diabetes. They can be prescribed as single-ingredient drugs or in combination with other medicines used to treat diabetes, such as metformin (see Table 1 below).Searching the available medical literature and the FDA Adverse Event Reporting System (FAERS) database resulted in the identification of several cases of severe joint pain linked to DPP-4 inhibitor use. Symptoms started as early as the first dose up to years after that dose. Discontinuing the DPP-4 inhibitor typically relieved all related pain within a month. However, some patients experienced severe joint pain again after restarting the same drug or a different DPP-4 inhibitor.The FDA is encouraging all health care professionals and patients to report any side effects connect to DPP-4 inhibitor use. Reports can be made to the FDA MedWatch program by either:

• Completing and submitting the report Online.

• Downloading form or calling 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form

• Submitting by fax to 1-800-FDA-0178.

FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain