More than 940 cases have been filed in the U.S. District Court, District of New Jersey and centralized before a single judge over alleged side effects with the type 2 diabetes drug canagliflozin, known by the brand names Invokana and Invokamet. The cases were first consolidated in December of last year.
Pending cases target Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, makers of Invokana and Invokamet. Serious complications linked to use of the drugs include diabetic ketoacidosis, kidney damage, and lower limb amputations, most of which involve the toes.
Canagliflozin, the active ingredient in Invokana and Invokamet, is in a family of diabetes drugs known as SGLT2 inhibitors. They work by preventing the absorption of glucose by the kidneys by excreting excess glucose through the urine.
Invokana was approved in March 2013 and became the first SGLT2 inhibitor on the U.S. market. Invokamet, a combination of canagliflozin and the long-used diabetes drug metformin, was approved in August 2014.
Since 2013, the Food and Drug Administration (FDA) has added new warnings or strengthened existing warnings on many SGLT2 inhibitors, particularly Invokana and Invokamet. In May 2015, the FDA ordered all SGLT2 inhibitors to add warnings about the risk of diabetic ketoacidosis, a serious condition in which too much acid builds up in the blood. The agency also required the drugs to warn about the risk of serious urinary tract infections, which can result in serious blood or kidney infections.
In September 2015, the FDA strengthened warnings on Invokana and Invokamet regarding an increased risk of bone fractures and decreases in bone mineral density. In June 2016, the FDA strengthened existing warnings on Invokana, Invokamet, Farxiga and Xigduo regarding acute kidney injury. And in May 2017, the FDA added a black box warning to Invokana and Invokamet regarding an increased risk of lower limb amputations.
In December 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated a handful of Invokana and Invokamet lawsuits in New Jersey federal court over allegations that Johnson & Johnson and Janssen failed to warn consumers about Invokana side effects. The number of cases has jumped to nearly 1,000 in just one year.
Source: U.S. District Court, District of New Jersey