FDA Gives Invokana Black Box Amputation Warning
Based on new data from two large clinical trials, the FDA issued a new Black Box warning for the Type 2 diabetes drug, Invokana, Invokamet and Invokamet XR. Both studies the organization reviewed showed an increased risk of leg and foot amputations to patients using Invokana. Because of this, the FDA required Invokana to have a Black Box warning, the most severe warning the FDA can give, about leg and foot amputations.
Studies Confirm Amputation Risk
The FDA made the decision after reviewing two large studies the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus).
CANVAS found that 7 out of 1,000 patients taking Invokana will need lower-limb amputation. This is a twofold risk of amputation. Invokana is the best-selling inhibitor drug on the market for Type 2 diabetes, therefore hundreds of thousands of people who take Invokana are completely unaware that a seemingly innocent cut on a toe, may lead to amputation because of their Invokana use.
CANVAS-R also showed the same risk of leg and foot amputations compared to patients treated with a placebo. Amputations of the toe and middle of the foot were the most common, however; amputations involved the leg, below and above the knee also occurred. Some even had multiple amputations, which involved both limbs.
Invokana’s Other Risks
On May 15, 2015, the United States Food and Drug Administration (FDA) issued a safety communication that Invokana may lead to diabetic ketoacidosis (DKA). DKA is a dangerous complication of diabetes. Around 14% of all diabetics are hospitalized because of it. This illness can lead to coma and death. Sixteen percent of all diabetes-related deaths are linked to DKA.
DKA happens when the body starts using fats as fuel instead of sugar or glucose. Insulin aids the body in using sugar as fuel, but when a person has diabetes the body cannot use sugar for fuel. Instead, it uses fat. When the fat is brown down, it causes the body to produce acidic chemicals. These chemicals are called ketones. Ketones build up and poison the body. This build up can cause organs to malfunction.
After an Invokana Injury
Consult a doctor before stopping any medication, but make sure you contact us immediately. We are litigating these cases right now and have over 40 cases pending in Philadelphia alone. The Michael Brady Lynch Firm has decades of experience going against large pharmaceutical companies and winning multi-million dollar judgments.
You deserve compensation. It can never replace what you have lost, but it can help you recover medical expenses, lost wages and the loss of an ability to work. The consultation is completely free, and you are under zero obligation. We are available 24/7 to take your call.