The Food and Drug Administration has launched an investigation into a class of drugs used to treat diabetes. The class of drugs are known as SGLT2 inhibitor Type 2 diabetes medications and include Johnson & Johnson’s Invokana, AstraZeneca’s Farxiga (dapagliflozin) and Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin).
SGLT2 inhibitors work by stopping the kidneys from reabsorbing glucose into the blood and passing it out in urine. The FDA has received reports potentially linking these drugs to a form of acute pancreatitis, which occurs when the pancreas, the organ responsible for creating insulin, swells and suddenly becomes inflamed. Acute pancreatitis is painful, and about 10 percent of cases are fatal. Common symptoms include nausea and vomiting, rapid pulse, swollen abdomen and fever. Treatment usually involves hospitalization, antibiotics and a liquid diet. The most common causes of acute pancreatitis are gallbladder stones or heavy alcohol consumption. But some medications can also cause it. The FDA previously warned about acute pancreatitis in the DPP-4 class of Type 2 diabetes drugs, and is now investigating adverse event reports for SGLT2 inhibitors.
While the FDA announced it intended to explore further this potential link, it took caution that no conclusions have been drawn thus far. “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA said on its website. “It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”
Invokana is the best-selling drug in this class and has had a checkered history. After the drug’s approval in 2013, the FDA found certain safety issues concerning the drug including diabetic ketoacidosis (DKA), kidney injury and urinary tract infections that may lead to blood infections.
If you or a loved one have taken Invokana or a similar drug and have suffered kidney injury, please contact Attorney Joe Saunders for a free initial consultation.