In March 2013, the Food and Drug Administration (FDA) approved a novel new type 2 diabetes treatment called Invokana. The drug, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals, was the first in a class of diabetes drugs known as SGLT2 inhibitors. Unlike other diabetes medications that work through the pancreas or liver, Invokana lowers blood sugar by pushing excess sugar through the kidneys where it is excreted through the urine.
The drug was almost an immediate hit, offering the benefit of weight loss to a population of patients often plagued by obesity. Other drugs, such as the Invokana and insulin combo pill Invokamet, and brands Jardiance, Farxiga and Xigduo, were approved.
But the honeymoon was coming to an end. Since 2015, the FDA has strengthened existing warnings or added new warnings to some or all drugs in the class. The only one targeted by all strengthened warnings – Invokana.
Here is a timeline of SGLT2 Inhibitor warnings:
May 2015 – Just two years and two months after Invokana hit the market, the FDA issued a Drug Safety Communication warning that all SGLT2 inhibitors were linked to ketoacidosis, a serious condition in which too much acid builds up in the blood. Ketoacidosis, also known as diabetic ketoacidosis or DKA, can lead to diabetic coma or death if left untreated.
At the same time, the FDA warned that SGLT2 inhibitors were also 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 – Soon after, the FDA issued a second Drug Safety Communication notifying the public that it was strengthening warnings for Invokana and Invokamet regarding an increased risk of bone fractures, as well as adding new warnings about decreases in bone mineral density.
June 2016 – The FDA announced it was strengthening existing warnings on Invokana, Invokamet, Farxiga and Xigduo regarding acute kidney injury, also referred to as AKI or simply kidney damage.
October 2016 – The FDA announces it is investigating data that shows an increased risk of leg and foot amputations – mostly affecting the toes – 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 Janssen failed to warn consumers about serious health risks involving Invokana.