The FDA has approved Invokana to reduce end-stage kidney disease, decreased kidney function, cardiovascular health and heart failure in adult patients living with Type 2 diabetes and diabetic kidney disease (nephropathy). Invokana is an SGLT2 inhibitor associated with amputation and diabetic ketoacidosis risks. The FDA’s recent move makes Invokana the only SGLT2 drug to address diabetic kidney disease and hospitalizations related to heart failure. Currently, one in three Type 2 diabetes patients also lives with diabetic kidney disease.
Canagliflozin, the generic form of Invokana, and other SGLT2 inhibitors treat diabetes by removing excess blood sugar from the body through the urine. The FDA approved Invokana in 2013 for this purpose and, based on the FDA’s latest assessment, this method assists with reduced kidney failure.
Data Behind the Decision
Swaying the FDA’s decision, data from the Phase 3 CREDENCE study was published in April 2019 and presented at the June American Diabetes Association meeting. The study found that patients given 100mg of Invokana experienced a 30-percent lower risk for end-stage kidney disease (ESKD), 20-percent lower risks for cardiovascular death, heart attack and stroke, and 39-percent lower hospitalization risks for heart failure, compared to patients given a placebo. Approximately 4,401 patients living with Type 2 diabetes and Stage 2 or 3 diabetic kidney disease were involved.
Nevertheless, Invokana continues to elevate patient risks for diabetic ketoacidosis, genital mycotic infections, limb amputations and bone fractures.
The purpose of this study was to find a solution to the progression of diabetic kidney disease, which may necessitate dialysis if left untreated, and to reduce the number of cardiovascular-related hospitalizations. CREDENCE built upon a 2008 FDA measure, which requires pharmaceutical companies to assess their drugs’ cardiovascular effects on a larger scale for safety. Among all diabetes medications, SGLT2 inhibitors is the first class to have a secondary preventative measure for cardiovascular events.
Overarching Trend for SGLT2 Inhibitors
Invokana is not the only SGLT2 inhibitor to provide a secondary preventative measure. Farxiga was also approved for reducing hospitalization related to heart failure in patients living with Type 2 diabetes. The FDA also granted Fast-Track designation to Jardiance for reducing hospitalizations related to heart failure and cardiovascular deaths.
For Farxiga, the FDA based its decision on the DECLARE-TIMI 58 CV Outcomes study. Researchers examined over 17,000 patients living with Type 2 diabetes and heart disease for over four years. Patients given Farxiga were 27 percent less likely to be hospitalized for heart failure than those given a placebo. Between both groups, data shows that patients had similar incidents of heart attack, stroke or death from heart disease.
Concerning Side Effects
The FDA’s decision comes at a time when the alarming side effects of Invokana and other SGLT2 inhibitors have come to light. Patients using these drugs have elevated risks for:
- Kidney injury
- Low blood pressure
- Low blood sugar
- Yeast infections and UTIs
- Urosepsis and pyelonephritis
- Necrotizing fasciitis of the perineum
- Hypersensitivity reactions
- Bone fractures
Of the above conditions, diabetic ketoacidosis (DKA) often serves as the catalyst. Patients may develop DKA when their insulin levels drop too low, which prevents cells from receiving energy and causes the body to overproduce ketones, or blood acids. This sets off a chain reaction that may lead to:
- Renal toxicity
- Kidney failure
- Sudden weight loss
- Organ and bone damage
- Heart attack
- Heart failure
- Pulmonary edema
- Blood clots
Many patients who were given Invokana and other SGLT2 inhibitors without being informed of the possible risks have experienced severe, life-threatening complications. If you or a loved one have found yourself in this situation, it’s time to hold the drug manufacturers responsible. To speak with one of our dangerous drug lawyers, give us a call today.