Invokana and Other Diabetes Drugs
Drugs in SGLT2 Inhibitor Class Used to Treat Type 2 Diabetes Linked to Serious Side Effects
The FDA (U.S. Food and Drug Administration) recently released a series of alarming safety warnings regarding multiple, widely-used medications used to treat Type 2 Diabetes. These medications belong to a specific class of prescription medicines known as SGLT2 inhibitors.
The FDA announced these warnings after receiving an influx of reports linking prescriptions in the SGLT2 inhibitor class, most notably Invokana (generic name: Canagliflozin), to Ketoacidosis (DKA), significant cardiac events, blood infections, and serious urinary tract infections resulting in kidney infections and/or kidney failure.
SGLT2 inhibitors: Which Drugs Comprise this Dangerous Class?
Drugs classified as sodium-glucose cotransporter-2 (SGLT2) inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with Type 2 Diabetes. If left untreated, Type 2 Diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Invokana and other SGLT2 inhibitors are prescribed to patients in order to lower blood sugar by causing the kidneys to remove sugar from the body via urine. They can be taken as single-ingredient products as well as in combination with other diabetes medicines such as metformin.
SGLT2 Inhibitors and their Manufacturers
- Invokana (Canagliflozin) - Janssen Pharmaceuticals
- Farxiga (Dapagliflozin) - Bristol-Meyers Squibb Company, and AstraZeneca Pharmaceuticals
- Jardiance (Empagliflozin) - Boehringer Ingleheim Pharmaceuticals with Eli Lilly and Company
- Invokamet (Canagliflozin and Metformin) - Janssen Pharmaceuticals
- Xigduo XR (Dapagliflozin and Metformin extended-release) - Bristol-Meyers Squibb Company, and AstraZeneca Pharmaceuticals
- Glyxambi (Empagliflozin and Linagliptin) - Boehringer Ingleheim Pharmaceuticals with Eli Lilly and Company
Dangerous Side Effects Linked to Invokana and Other SGLT2 inhibitors
The FDA's recent announcements serve to warn anyone diagnosed with Type 2 Diabetes who is taking Invokana, or other drugs in the SGLT2 inhibitor class, of the potentially life-threatening side effects that these drugs may cause. The FDA is mandating that drug manufacturers disclose the dangerous complications linked to these frequently-prescribed diabetes medications to consumers due to mounting patient reports supporting this link.
Invokana and Fournier's Gangrene
The FDA has warned that Invokana can cause a deadly bacterial infection called Fournier’s gangrene. The bacteria can penetrate the tissue under the skin of the genitals, usually through a cut. The infection then spreads quickly, potentially affecting the thighs, stomach, and chest.
Fournier’s gangrene most often occurs in men between the ages of 50-79, and having diabetes is a risk factor. Patients taking Invokana are at an increased risk for skin ulcerations that can lead to infection. Symptoms of Fournier’s gangrene include:
- Pain and swelling of the genitals or anus
- Unpleasant odor coming from the affected skin tissue
- Crackling sound when touching the affected skin
Invokana, SGLT2 Inhibitors and Ketoacidosis
Since being FDA approved in 2013, Invokana along with each of the drugs in the SGLT2 Inhibitor class, have been individually linked to cases involving diabetic patients developing Ketoacidosis. All patients in these instances required hospitalization or treatment in an emergency department. Ketoacidosis, also referred to as Diabetic Ketoacidosis (DKA) in diabetic individuals is a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of Ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
Other Life-threatening Side Effects
In addition to Ketoacidosis, the FDA also identified additional serious side effects experienced by patients taking SGLT2 Inhibitors. These include life-threatening blood infections (Urosepsis), and urinary tract infections which, in turn, resulted in kidney infections (Pyelonephritis) and/or kidney failure. All patients in these cases were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat the kidney failure.
In a separate study conducted by the manufacturer of Invokana, Janssen Pharmaceuticals, an increased risk of diabetic patients experiencing a serious cardiac episode, like a heart attack, while taking the drug was observed. This study found that users of Invokana were 6.49 times more likely to suffer a cardiac event within the first 30 days of use than a study participant who was prescribed a placebo.
Our Attorneys Are Here to Help If You've Suffered Serious Side Effects from Unsafe Medicines
Most people take medications, like Invokana and other SGLT2 Inhibitors to recover from an illness or help treat a chronic condition, like Diabetes. The last thing they expect is to wind up in the hospital or deal with serious complications because of the drug they thought would help them.
If an unsafe medication turned your world turned upside down, we know your health is a top priority. You may wonder whether you have a case. You may have questions about what to do. Medical bills pile up. Maybe you can't work. You're probably under a lot of physical, mental, emotional, and financial stress.
Unfortunately, many patients who suffer serious side effects from a medication don't realize that they may have a case until it's too late. There are time limits to file a claim, so if you're unsure whether you need a lawyer, it's better to be safe than sorry. Contact us today for your free, legal consultation to learn your legal options.
Call 1-866-943-3427, or fill out the form at the top right of this webpage. There's no obligation to use our services, so there's nothing to lose.
Sources: “FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections.” FDA.gov. December 4, 2015.
“FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood.” FDA.gov. May 5, 2015.