Update Invokana Black Box Warning Label Swiftly: FDA

Update Invokana Black Box Warning Label Swiftly: FDA

Introduction

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of Invokana, Invokamet, and Invokamet XR, which are drugs prescribed for treating Type 2 diabetes, to speed track the process to include a Black Box Warning Label to warn about the increased risk of leg and foot amputations.

In 2016, the product labels were updated to reflect acute kidney disorder after taking Invokana following FDA's order. In 2017, the FDA issued a similar notice to Johnson & Johnson to alert the patients about the risk of amputations of the leg and foot. Unfortunately, more than 1,000 patients underwent leg amputation after taking Invokana, and related lawsuits have been filed against J&J and its subsidiary Janssen.

Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have also faced a product liability lawsuit filed by a man from Texas for undergoing transmetatarsal and guillotine amputations of the right foot above the ankle. The plaintiff here holds the defendants responsible for not adequately warning the users and the medical community about a large number of leg and foot amputation problems linked with Invokana. The case was filed in the U.S. District Court for the District of New Jersey.

According to the guidelines published by ADA (American Diabetes Association), Invokana may be considered to reduce major cardiovascular events after lifestyle management and metformin in patients with T2D and established cardiovascular disease.

Over a period of time, Invokana has been linked to aggravating certain medical conditions one of them being 'Ketoacidosis,' a condition in which the body produces high levels of blood acids known as ketones. If left untreated, this condition can be fatal. Since its launch in the U.S. markets, several patients have developed ketoacidosis to the point of needing an emergency room visit or hospitalization.

The most common side effects include genital yeast infections, urinary tract infections, and changes in urination. The side effect listed by the manufacturer is weight loss of between two to three percent. It is also known to lower blood pressure anywhere between three to five mmHg. However, the major side effects mentioned in various lawsuits, are not listed by the manufacturer.

Invokana injury lawsuits are mounting in the consolidated multidistrict litigation (MDL) in the U.S. District Court, District of New Jersey (MDL No: 2750), and the first of Invokana amputation trial is expected to begin in September 2018.