September 29, 2017 – San Diego, CA. In May 2017 the FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information.
Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin
(Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning to be added to the canagliflozin drug labels to describe this risk.
What is Invokana (canagliflozin)?
According to the American Diabetes Association (ADA) 29.1 million Americans, or 9.3% of the population, had diabetes in 2012. Diabetes is a medical condition that causes blood glucose, or sugar, levels to increase to higher than normal amounts. When a patient has diabetes, their body does not use insulin correctly, causing insulin resistance.
In March of 2013, the FDA approved Invokana for use by patients with diabetes. The company behind the drug, Johnson & Johnson, claimed it would improve glucose control in people with Type 2 diabetes. The drug is a new class of diabetes called SGLT2, or sodium-glucose co-transporter 2.
Leg and Foot Amputations aren’t the only side effect of Invokana.
Back in May of 2015 the FDA issued a warning that SGLT2 inhibitors can cause diabetic ketoacidosis. Without enough insulin, the body starts to break down fat for fuel and builds up toxic acids in the bloodstream. The signs and symptoms of this condition develop rapidly, usually within 24 hours. Some complications with diabetic ketoacidosis are low potassium, swelling in the brain, and low blood sugar. If left untreated, this condition is fatal.
Symptoms of diabetic ketoacidosis:
- Frequent urination
- Excessive thirst
- Abdominal pain
- Vomiting & nausea
- Shortness of breath
- Fruity-scented breath
The FDA found around 20 cases of diabetic ketoacidosis in patients taking SGLT2 inhibitors. These cases occurred from March 2013 to June 2014 and the patients required treatment in an ER or hospital for the condition.
What is involved in the Invokana Settlement Lawsuits?
As with any defective drug lawsuit claim, lawyers begin the process called “discovery phase” whereby they seek out any information about Invokana as they can find. This can include anything found by the FDA, or even the drug manufacturer. This information gathering is then compiled and studied generally by more than one lawyer. Many times when lawyers work together it’s known as a co council agreement.
When the trial begins a jury will review all the facts found during discovery and then decide what Invokana damages should be awarded to those hurt from the drug. Many times this is a long drawn out process. Many questions are asked to determine the extent of the Invokana injury, any medical treatment that was needed as a result of the injury. Other factors include:
- Any lost wages and medical expenses and or economic damages.
- Are there any long term injuries that could affect the plaintiff’s health in the future?
- What is the mental and physical well being of the plaintiff?
The first of what could be multiple lawsuits are to begin at the end of 2018. However there is little reason to believe the drug maker, Janssen, a division of Johnson & Johnson would settle as of today. Many times drug manufacturers will set aside a monetary pool of money to settle drug lawsuit cases.
Invokana Amputation Lawsuit – How to file an Invokana Claim.
If you or someone you love has suffered in any way as a result of using Invokana diabetes medication, you need to take action. You can do so by seeking the help of our Invokana lawsuit attorney & lawyers who have been holding corporations, like Janssen, accountable for the harm they have inflicted on consumers for decades.