WHAT IS INVOKANA?
Invokana is a diabetic drug manufactured by Johnson & Johnson. It was designed to treat low blood sugar levels in adults with Type 2 diabetes. It falls into the SGLT2 inhibitors diabetes drug class. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through urine. The FDA approved Invokana March 29th, 2013.
The Canagliflozin Cardiovascular Assessment Study showed the following risk of amputation for patients over a year's time:
5.9 out of every 1,000 patients treated with canagliflozin
2.8 out of every 1,000 patients treated with placebo
This studied the effects of canagliflozin on renal endpoints in adult patients with Type 2 diabetes. The risk of amputation for this studied resulted as follows:
7.5 out of every 1,000 patients treated with canagliflozin
4.2 out of every 1,000 patients treated with placebo
FOOD & DRUG ADMINISTRATION (FDA)
May 18th, 2017
The Food and Drug Administration (FDA) released a Drug Safety Communication and added a Black Box warning regarding the increased risk of leg and foot amputations with Invokana, Invokamet, and Invokamet XR.
Diabetic Ketoacidosis (DKA) warning was amended to include reports of "fatal" injuries. The original DKA warning was added to labels in December 2015.
June 14th, 2016
The Food and Drug Administration (FDA) issued kidney warnings for Invokana, Invokamet, Farxiga, and Xigduo XR. They stated these drugs were linked to reports of acute kidney injury that could require hospitalization.
The FDA released new labeling guidelines for SGLT-2 inhibitors. They required labels to add warnings for Diabetic Ketoacidosis (DKA).
The Food and Drug Administration (FDA) revised Invokana and Invokamet labels to include information about the risk of bone fracture and decreased bone density.
The Food and Drug Administration (FDA) warned that SGLT2 inhibitors, such as Invokana may lead to ketoacidosis, where the body produces high levels of ketones, ultimately causing overly acidic blood.
March 29th, 2013
The FDA approves Invokana.
Impaired Kidney Function
Urinary Tract Infections
Abnormal Weight Loss
INVOKANA LAWSUIT UPDATES
MDL 2750: December 12th, 2016
Judge: Brian R. Martinotti
Venue: District of New Jersey
Judge Brian Martinotti has stated in a July 27th, 2017 Case Management Order (CMO) that the Court will choose the first (3) bellwether cases by January 19th, 2018. The order further explains these cases will not be joint or multi-plaintiff trials.
September 2018 (tentative)