A painful inflammation of the pancreas called acute pancreatitis is a potential new safety issue identified with the new class of type 2 diabetes treatments known as SGLT2 inhibitors. The side effect was identified through the Food and Drug Administration (FDA) adverse event tracking database, which identifies potential hazards with drugs each quarter.
The FDA identifies potentially harmful side effects with medications to determine if further action – such as additional or strengthened warnings – are required. The agency said it is currently evaluating the need for regulatory action regarding the link between SGLT2 inhibitors and acute pancreatitis. SGLT2 inhibitors include the brand names Farxiga, Glyxambi, Invokamet, Invokana, Jardiance, Syndardy, and Xigduo XR.
Other classes of type 2 diabetes medications, such as DPP-4 inhibitors (for example, Januvia) and GLP-1 agonists (for example, Byetta) have been linked to acute pancreatitis. The painful condition can also put users at increased risk of pancreatic cancer.
In March 2013, Invokana became the first SGLT2 inhibitor to be approved in the U.S. Since then, the FDA has strengthened or added new warnings to most SGLT2 inhibitors.
Those warnings include a decrease in bone mineral density, increased risk of bone fracture, risk of serious urinary tract infections, and potentially increased risk in lower limb amputations. The FDA also warned that SGLT2 inhibitors could increase the risk for life threatening conditions such as acute kidney injury, or kidney failure, and ketoacidosis, a condition in which too much acid builds up in the blood.
Consumers who experience any adverse events with SGLT2 inhibitors should report them to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.