The SGLT2 inhibitor class of type 2 diabetes medications is expected to continue to grow in the coming months with new treatments on the verge of Food and Drug Administration (FDA) approval and positive cardiovascular outcomes data. But the drugs remain saddled with a growing list of side effects.
The FDA is currently reviewing a new SGLT2 inhibitor from Pfizer and Merck called ertugliflozin, an oral therapy that lowers blood glucose levels by allowing excess glucose to be secreted through the urine. Merck is also poised to obtain clearance for other ertugliflozin combination drugs, such as one that includes the long-used diabetes treatment metformin as well as with Merck’s DPP4 inhibitor Januvia.
Lexicon and Sanofi are also collaborating on an SGLT2 inhibitor called sotagliflozin for both type 1 and type 2 diabetics. Sotagliflozin inhibits the SGLT1 protein responsible for glucose absorption in the gastrointestinal tract, as well as SGLT2, the protein responsible for the reabsorption of glucose by the kidney. This drug is not expected to be eligible for review for another year or two.
The first SGLT2 inhibitor, Invokana, was approved in 2013, and since then the FDA has added new warnings or strengthened existing warnings on all or some of the drugs in this class. For example, the FDA warned in May 2015 that all drugs in the class could increase the risk of ketoacidosis, a serious condition in which too much acid builds up in the blood. The agency also warned that SGLT2 inhibitors cold cause serious urinary tract infections.
In September 2015, the FDA strengthened warnings for Invokana and Invokamet that use could increase the risk of bone fractures and lower bone mineral density. In June 2016, the FDA also strengthened warnings on Invokana, Invokamet, and Xigduo regarding an increased risk for acute kidney injury.
In May 2017, the FDA added its strongest warning to Invokana and Invokamet – a boxed warning – regarding an increased risk for lower limb amputations.
Invokana makers Johnson & Johnson’s Janssen Pharmaceuticals face hundreds of lawsuits alleging the drug company did not adequately warn of Invokana side effects.
Modern Medicine Network