Kentucky has one of the highest populations of diabetics in the country, and the problem seems to be getting worse. In 2000 6.5% of Kentuckians was diagnosed with diabetes; that number grew to 13.4% of the population in 2015. Diabetes is the 7th leading cause of death in Kentucky. With numbers like these it is no wonder that the market for diabetes drugs is at an all-time high. One of the fastest growing diabetes medication is Invokana, manufactured by Johnson & Johnson. Invokana® was introduced in 2013 and it is trending to have over $1 billion in sales in 2015.
However, the FDA has issued two separate warnings to consumers regarding the safety of Invokana®. The first warning in 2015 stated that Invokana®, and similar diabetes drugs, may cause ketoacidosis, a condition where the body produces high levels of blood acids that can have serious health consequences. Then in May of 2017, the Food and Drug Administration (FDA) issued a Black Box Warning.
This warning was sent to physicians and the medical community to address two recently published, independent studies indicating that patients prescribed the Type 2 Diabetes drug, Invokana® (also Invokamet® and Invokamet XR®) had two times the likelihood of needing toe, foot or leg amputation as compared to patients who took a placebo drug.
What is Invokana®?
Invokana® is one of a new class of type II diabetes drugs called Sodium-Glucose Costransporter-2 (SGLT-2) inhibitors. SGLT-2 Inhibitors work by altering the normal kidney function so that less sugar is reabsorbed into the blood and the surplus glucose is excreted through the urine. The active ingredient in Invokana® is canagliflozin.
Side Effects of Invokana®
The FDA warning on Invokana came after the agency’s database identified 20 cases of acidosis that required hospitalization in the first 14 months of Invokana’s® introduction. Additionally, there were over 450 additional adverse events reported for Invokana® in its first year on the market.
The serious side effects linked to Invokana® include:
- Kidney failure
- Kidney stones
- Kidney damage
- Urinary tract infections
- Fluid/electrolyte problems
- Weight loss
What are the Symptoms to Look for Regarding Risk of Amputation?
Since the 2015 FDA warning of Ketoacidosis associated with Invokana®, several new studies commenced to study the safety of Invokana®. Two studies called CANVAS and CANVAS-R showed that while Invokana® users were 14% LESS likely to experience a cardiovascular event, the risk of amputation doubled. One of the studies also indicated that people using Invokana® saw a higher rate of bone fractures.
- Foot ulcers
- Pain, tenderness, or sores in legs or feet
Patients should report such symptoms to their medical provider. Patients should not discontinue use of Invokana without speaking to a physician.
Invokana Lawsuits in Kentucky
Kentucky patients who have developed ketoacidosis since beginning Type 2 Diabetes treatment with Invokana may want to explore their legal options. Currently there are a number of lawyers exploring lawsuits against Johnson& Johnson, the maker of Invokana, alleging that the pharmaceutical company did not adequately warn users of the risks of ketoacidosis or of the increased risk of amputation. An attorney can help you to determine if your case warrants investigation.
Please contact Brett H. Oppenheimer, a Kentucky lawyer, who can review your case. Send him a message online or call (502) 242-8877.