With new diagnoses of type 2 diabetes (T2D) at record highs, hundreds of thousands of men and women have been prescribed Invokamet (canagliflozin + metformin) to manage their disease. However, the drug has been linked to thousands of instances of life-threatening complications such as diabetic ketoacidosis and forced amputations of the toes, feet and legs. Many patients have filed lawsuits against the Janssen Pharmaceuticals blockbuster drug.
What Is Invokamet?
Invokamet is the brand name combination of canagliflozin and metformin. It was developed by Janssen Pharmaceuticals for use in treating type 2 diabetes. The drug was approved by the Food and Drug Administration in March 2013, but it wasn’t long until patients began to report adverse side effects previously not listed on the drug’s label.
This prompted the Food and Drug Administration to conduct an independent study which showed patients taking Invokamet were twice as likely to undergo amputations compared to those taking a placebo. In 2017 The FDA issued a Black Box Warning, demanding label changes to outline the serious risk of leg and foot amputations associated with the drug. This warning came on the heels of another FDA warning from 2015, which described an increased risk in developing potentially fatal diabetic ketoacidosis.
What Is Type 2 Diabetes?
Type 2 diabetes is a condition that alters the body’s ability to process and regulate sugars in the blood. The main causes for the disease are poor diet and lack of exercise, though there are also proven genetic risk factors.
Type 2 diabetes rates have skyrocketed since the late 1960’s, with approximately 392 million people diagnosed with the disease in 2015. Those diagnosed with type 2 diabetes have a ten year shorter life expectancy due to a host of complications associated with the disease, including: cardiovascular disease, stroke, lower limb amputations, and increased rates of hospitalizations.
Type 2 Diabetes Symptoms
Type 2 Diabetes can only be diagnosed by a licensed healthcare professional. If you experience any of the following symptoms, contact your physician immediately:
- Increased thirst and frequent urination
- Increased hunger
- Weight loss
- Blurred vision
- Slow-healing sores or frequent infections
- Areas of darkened skin
Type 2 Diabetes Risk Factors
Weight and inactivity are thought to be the two main causes of type 2 diabetes, though there are additional factors that may put a person at increased risk in developing the disease.
- Fat distribution (primarily in the abdomen)
- Family history of diabetes
- Increased age
- Gestational diabetes
- Polycystic ovarian syndrome
It is still unclear why many of these factors create an increased risk for type 2 diabetes. However, if you experience any of these signs or symptoms, it is recommended you undergo yearly screenings by your health care provider.
Invokamet And the FDA
The FDA has issued numerous warnings outlining the safety risks of Invokamet since its 2013 approval. Independent clinical studies have linked the drug to adverse conditions such as bone fractures, diabetic ketoacidosis (DKA), heart attack, kidney failure, and amputations of the foot, leg and toes.
A number of these complications were not originally listed as side effects of the drug. This prompted many people who were diagnosed and subsequently took Invokamet, to file lawsuits against Janssen Pharmaceuticals. In their Invokamet lawsuit, they are attempting to hold the manufacturer accountable for what they’re calling a “defective drug”.
May 15, 2015: “The U.S. Food and Drug Administration is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.”
May 16, 2017: “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.”
Both warnings included directions for patients and doctors who chose to continue their type 2 diabetes treatment with Invokamet. Despite these warnings that outline large increases in risk for developing both conditions, Janssen has yet to pull Invokamet from the market. Those injured by the drug have vowed to pursue the manufacturer in courts of law.