DPP-4 Inhibitor Serious Side Effects. Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors), a class of oral diabetes medications that includes Januvia, Onglyza, Trajenta, and Nesina, treat Type 2 diabetes by blocking DPP-4. Oral DPP-4 inhibitors work by increasing incretin levels in the pancreas which, in turn, inhibits the release of glucagon in the liver. Glucagon is responsible for increasing blood sugar levels. DPP-4 inhibitors are used in combination with diet and exercise to control blood sugar.
The Food and Drug Administration (FDA) recently issued a Drug Safety Announcement warning that DPP-4 inhibitors may cause severe, even 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 indicated in safety announcement. The FDA has directed the manufacturers of all medicines in this drug class to add new warnings about the joint pain risk to the labels.
The personal injury attorneys at Parker Waichman LLP are investigating the association between DPP-4 inhibitor diabetes medications and pancreatitis and joint pain and are also investigating potential lawsuits. If you or someone you know has suffered adverse reactions following treatment with these medications, our personal injury attorneys would like to hear from you.
Millions of Type 2 Diabetics Need Treatment
According to the Centers for Disease Control and Prevention (CDC), 29.1 million Americans—9.3 percent of the population—have been diagnosed with diabetes, an imbalance in the blood sugar that may lead to a number of problems if left untreated. When untreated, Type 2 diabetes may lead to serious health problems, including blindness, nerve and kidney damage, and heart disease, the FDA explains.
Diabetes is one of the leading causes of death in the United States. The CDC notes that the risk of death jumps by 50 percent if an individual has diabetes. Diabetes is also costly. The direct cost for medical care and the intangible costs, such as lost wages, are estimated to amount to $245 billion per year.
DPP-4 inhibitors are available both as single-ingredient medicines and combination drugs. The following medications have received FDA approval.
- Januvia (sitagliptin): Merck
- Onglyza (saxagliptin): AstraZeneca
- Tradjenta (linagliptin): Boehringer Ingelheim
- Nesina (alogliptin): Takeda
- Janumet (sitagliptin and metformin): Merck
- Janumet XR (sitagliptin and metformin extended release): Merck
- Kombiglyze XR (saxagliptin and metformin extended release): AstraZeneca
- Glyxambi (linagliptin and empagliliflozin): Boehringer Ingelheim
- Jentadueto (linagliptin and metformin): Boehringer Ingelheim
- Kazano (alogliptin and metformin): Takeda
- Oseni (alogliptin and pioglitazone): Takeda
Januvia was the first drug of this class to reach the market. Januvia received FDA approval in 2006 and now accounts for about three-quarters of all DPP-4 inhibitor sales.
According to the FDA, between Oct. 16, 2006 and Dec. 31, 2013, the agency identified 33 instances in which DPP-4 inhibitors had been linked to severe joint pain. Januvia was responsible for 28 of those reported cases. The FDA did not recommend Type 2 diabetics cease taking their medication, but encouraged physicians to monitor patients for joint pain potentially linked to Januvia and other DPP-4 inhibitors.
Patients started having symptoms from one day to years after they started taking a DPP-4 inhibitor. Symptoms usually eased in less than a month after the patient discontinued the DPP-4 inhibitor, but some patients developed severe joint pain again when they restarted the same medicine or began taking another DPP-4 inhibitor.