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DPP-4 Inhibitor Type 2 Diabetes Drugs Can Cause Severe Joint Pain, FDA Warns

Filed August 31st, 2015 F.A. Kelley

The Food and Drug Administration (FDA) has issued a safety communication warning patients with Type 2 diabetes that a class of diabetes drugs can cause severe, possibly disabling, joint pain.

“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.

Dipeptidyl peptidase-4 (DPP-4) inhibitors include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). These drugs work by making more insulin available to the body. Januvia was the first DPP-4 inhibitor to be approved. Januvia received 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. Proper control of diabetes may lessen the patient’s risk of heart attack or stroke, WebMD says. 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 without discussing this first with a doctor. Any patient who experiences “severe and persistent joint pain” when taking a DPP-4 inhibitor should contact a physician right away. “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 identified cases of severe joint pain associated with DPP-4 inhibitors using a search of the medical literature and the FAERS database (FDA Adverse Events Reporting System). According to the FDA’s analysis, people taking medications in this class did have a higher risk of severe joint pain. Symptoms can start any time from “from one day to years after they started taking a DPP-4 inhibitor.” The FDA says symptoms eased, “usually in less than a month” after the patient discontinued the DPP-4 inhibitor. But, the agency cautioned, 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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