SGLT2 Inhibitor Medications and Ketoacidosis: What You Need to Know
Invokana® is a new drug that is being widely prescribed for the treatment of Type 2 diabetes. It is offered as a monotherapy or in combination with metformin (Invokamet). Invokana is the first to market in a new class of T2D drugs called sodium glucose cotransporter-2 (SGLT2) inhibitors.
How Do SGLT2 Inhibitors Work?
Invokana’s mechanism of action is to control diabetic blood sugars by interfering with critical mechanisms in the human blood supply: the transporting and absorption of glucose (blood sugar) and sodium. Due to this mechanism of action, sugar is not metabolized and is excreted through the kidneys in a population already at risk for kidney disease.
Invokana has been on the market since spring, 2013 and since that time has had a significant number of adverse event reports related to kidney failure and ketoacidosis. Ketoacidosis is a condition due to starvation or uncontrolled Type I diabetes. Ketones are acid compounds that form in the blood when the body breaks down fats and proteins when it fails to metabolize nutrients systemically. Because untreated ketoacidosis can lead to death, typical cases of ketoacidosis usually lead to hospitalization.
Safety Announcement From the FDA About SGLT2 Inhibitor Side Effects
On May 15, 2015, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory linking this type of drug to diabetic ketoacidosis, a condition which can result in organ failure and death. An alarming number of FDA Adverse Event Reports have also linked this drug to kidney failure. The drug is contraindicated in patients with severe kidney impairment, but is not contraindicated in patients with less than severe kidney impairment. An analysis of the FDA adverse event database shows that patients taking Invokana are several times more likely to report kidney failure than those taking non-SGLT2 drugs for Type 2 diabetes. This is likely due to the mechanism of Invokana—rather than metabolizing blood sugar as insulin would do, it diverts the sugar through the kidneys, resulting in an overloaded renal capacity and potential kidney failure.
A review of the clinical trial data in the CANVAS study for Invokana also reveals that, within the first 30 days of use, the use of Invokana is associated with a 600% increase in cardiovascular events, including heart attack and stroke.
Invokana is marketed in the United States by Janssen Pharmaceuticals, a Johnson & Johnson Company. Invokana is already a blockbuster drug, with first quarter sales for 2015 at $278 million and yearly sales estimated to approach or exceed $1.3 billion.
Other SGLT2 Inhibitor Drugs That Have Been Linked to Ketoacidosis
The attorneys at Wayne Wright, LLP are reviewing cases of individuals who have taken Invokana (and the drugs listed below) who have suffered kidney failure, heart attack, stroke, died, or have been hospitalized for diabetic ketoacidosis. The drugs at issue are:
- Invokana® (canaglifozin)
- Invokamet® (canaglifozin and metformin)
- Farxiga® (dapaglifozin)
- Xigduo XR® (dapagliflozin and metformin extended-release)
- Glyxambi® (empagliflozin and linagliptin)
The Attorneys at Wayne Wright LLP May Be Able to Help You
If you or someone you love has been seriously injured by taking any of these drugs, you may be able to recover damages for your medical expenses, lost wages, and pain and suffering. The injury lawyers at Wayne Wright, LLP are experienced in going up against companies that have caused their clients harm. To speak with an attorney about your case, call us at 210-888-8888 to set up your free consultation.