FDA Safety Communication Warns that a Class of Type 2 Diabetes Drugs Can Cause Severe Joint Pain

Last week the Food and Drug Administration (FDA) issued a safety communication warning Type 2 diabetes patients that a class of diabetes drugs can cause severe and disabling joint pain.

The drug class—dipeptidyl peptidase-4 (DPP-4) inhibitors—includes Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). These drugs work by making more insulin available to the body.

“The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling,” the agency said in the safety announcement, which used the generic names of the drugs, NBC News reports.

The FDA has added new warnings about joint pain to the labels of all medicines in this drug class. The drugs are already linked with some potentially severe side effects. Januvia can cause pancreatitis, a severe inflammation of the pancreas that is not only painful but can also be deadly. A trial of more than 16,000 patients showed patients taking Onglyza had an increased risk of hospitalization due to heart failure, Reuters reported.

Januvia was the first drug in the DPP-4 class to be approved, receiving FDA approval in 2006. DPP-4 inhibitors are used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes. Type 2 diabetes, when untreated, can lead to serious problems, including blindness, nerve and kidney damage, and heart disease, the FDA explains. DPP-4 inhibitors are available as single-ingredient products and in combination with other diabetes medicines such as metformin. Janumet, Kombiglyze XR, Glyxambi, Jentadueto, and Oseni are among the combination medicines.

The FDA advises patients not to suddenly stop taking a DPP-4 inhibitor medicine, but to contact a physician right away if they experience “severe and persistent joint pain.” “Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate,” according to the FDA statement.

The FDA said the side effects can be caused by the drugs, but not always. In a search of the medical literature and the FAERS database (FDA Adverse Events Reporting System), the FDA identified cases of severe joint pain associated with DPP-4 inhibitors. According to the FDA’s analysis, people taking medications in this particular class did have a higher risk of severe joint pain. “Patients started having symptoms from one day to years after they started taking a DPP-4 inhibitor. After the patients discontinued the DPP-4 inhibitor medicine, their symptoms were relieved, usually in less than a month,” according to the FDA. But the agency said some patients developed severe joint pain again when they restarted the same medicine or began taking another DPP-4 inhibitor.

The FDA encourages patients and health care professionals to report side effects involving DPP-4 inhibitors to the FDA MedWatch program: www.fda.gov/medwatch/report.htm.

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