Since the new class of type 2 diabetes drugs known as SGLT2 inhibitors hit the market in 2013, the drugs have been repeatedly called out by the Food and Drug Administration (FDA) for various but serious adverse events. Yet, drug makers continue to develop new versions of this drug hoping to cash in on the billions of dollars spent on diabetes treatments.
SGLT2 inhibitors currently on the market include Invokana and Invokamet, Farxiga and Jardiance. The drugs work to lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
Drug makers Merck and Pfizer are currently collaborating on the development of ertugliflozin as a monotherapy, in combination with Merck’s Januvia from another class of diabetes drugs, and in combination with the long-used treatment metformin. Ertugliflozin is expected to be up for FDA approval later this year.
Lexicon and Sanofi are also collaborating on the SGLT2 inhibitor sotagliflozin, which also inhibits SGLT1. SGLT1 is the protein responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is the protein responsible for the reabsorption of glucose by the kidney. This drug is being tested in both type 1 and type 2 diabetics, and is not expected to be up for review for another year or two.
Since SGLT2 inhibitors were approved, the FDA has strengthened or added new warnings to the safety labels of the drugs. Here is a rundown of risks that emerged after the drug hit the market:
May 2015 – The FDA issued a Drug Safety Communication that SGLT2 inhibitors were linked to ketoacidosis, a condition in which too much acid builds up in the blood. If left untreated, ketoacidosis can lead to diabetic coma or death.
At the same time, the FDA warned that SGLT2 inhibitors had ben linked to serious urinary tract infections, which in some cases resulted in a serious blood infection called urosepsis, or a kidney infection called pyelonephritis.
September 2015 – The FDA issued a Drug Safety Communication that it was strengthening the warnings for the SGLT2 inhibitors Invokana and Invokamet regarding an increased risk for bone fractures, as well as adding a new warning about decreases in bone mineral density.
June 2016 – The FDA announced that it was strengthening existing warnings on SGLT2 inhibitors Invokana, Invokamet and Xigduo regarding an increased risk for acute kidney injury.
October 2016 – the FDA announced it was investigating an increased risk of lower limb amputations in patients taking Invokana and Invokamet.
December 2016 – The U.S. Judiciary Panel on Multidistrict Litigation consolidated dozens of lawsuits in New Jersey federal court alleging Johnson & Johnson and its subsidiary Janssen Pharmaceutical failed to warn consumers of serious health risks involving its diabetes treatments Invokana and Invokamet.