Product News and Recalls

FDA: DPP-4 Inhibitors Like Januvia May Cause Severe Joint Pain

fda issues warning on DPP-4 inhibitorsThe U.S. Food and Drug Administration (FDA) has issued a safety communication warning that certain type 2 diabetes drugs, called dipeptidyl peptidase-4 (DPP-4) inhibitors, may lead to severe joint pain in patients taking them. Among the diabetes drugs named in the announcement are Merck’s Januvia (sitagliptin) and AstraZeneca and Bristol-Myers Squibb’s Onglyza (saxagliptin); as well as Incretin mimetic drugs containing linagliptin or alogliptin.

Januvia was approved by the FDA in late 2006 as a treatment for patients with type 2 diabetes. However, Januvia, as well as another Merck DPP-4 inhibitor marketed as Janumet, has been linked in medical studies to pancreatitis and pancreatic cancer. For instance, a University of California study found a sixfold increase in pancreatitis cases among patients taking Januvia. Similar results were observed in patients taking Byetta, another incretin mimetic. Moreover, it has not sufficiently been proven that Januvia or Byetta have any advantage over other types of diabetes medications.

Patients who were diagnosed with pancreatitis or pancreatic cancer after using Januvia or Byetta have come forward and filed pancreatitis and pancreatic cancer lawsuits. These lawsuits have been centralized along with others concerning Januvia, Janumet, Byetta, and Victoza in a multidistrict litigation in the Southern District of California.

The FDA’s recent safety announcement comes after a review of the agency’s adverse event reporting system and pertinent medical literature turned up multiple cases of severe join pain in patients who took a DPP-4 inhibitor. Pain began anywhere from one day to several years after taking the medication. After suspending use of the drug, patients’ symptoms were relieved. In some cases, restarting a DPP-4 inhibitor caused patients’ joint pain to return.

For now the FDA advises DPP-4 inhibitor users not to stop taking their medications, but to contact a health care professional immediately should they experience severe and persistent joint pain. The agency is advising practitioners to consider whether use of a DPP-4 inhibitor may be responsible for a patient’s joint pain.

Speak with your doctor before starting or stopping any medications. If you or someone you know was diagnosed with pancreatitis or pancreatic cancer after using a DPP-4 inhibitor like Januvia, contact Lopez McHugh today for a free legal consultation with one of our experienced pharmaceutical attorneys. You may be entitled to compensation through a pancreatitis or pancreatic cancer lawsuit.