Type 2 diabetes affects about 25 million people in the United States, or more than 8% of the nation’s population. Type 2 diabetics suffer from an excess of blood sugar (glucose) because their bodies do not use insulin properly.
Diabetics are a lucrative market for pharmaceutical companies. While exercise and diet are often the best means of controlling type 2 diabetes, drug manufacturers have promoted a number of medications to help diabetics manage their disease. One approach targets the kidney, which plays an important role in the body’s reabsorption of blood sugar.
The Food and Drug Administration (FDA) approved Invokana in 2013 to help type 2 diabetics control their blood sugar levels. Invokana is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Drugs in that class reduce blood sugar levels by preventing the kidneys from returning glucose to the bloodstream.
The Role of Kidneys and SGLT2 in Blood Sugar Maintenance
Kidneys help maintain appropriate blood sugar levels by removing glucose before it is lost through urination. The SGLT2 protein enables the kidneys to return the “filtered” glucose to the bloodstream. In people who do not suffer from diabetes, the return of glucose helps the body maintain its supply of blood sugar.
The kidneys continue to return glucose to the blood even when the body’s supply of blood sugar is already too high. By preventing the SGLT2 protein from doing its job, an SGLT2 inhibitor forces the kidneys to release more glucose into urine, reducing the amount of glucose in the bloodstream.
Several SGLT2 inhibitors have been tested for the control of type 2 diabetes. One of those, developed by the Japanese pharmaceutical company Mitsubishi Tanabe Pharma, is known by the generic name canagliflozin. Mitsubishi Tanabe Pharma licensed canagliflozin to Janssen Pharmaceuticals, a division of Johnson & Johnson, which markets the drug under the trade name Invokana.
Invokana and Ketoacidosis
The body uses blood sugar as its source of energy. When blood sugar supplies are inadequate, the body begins to burn fat to obtain energy. That process produces chemicals called ketones. Blood becomes acidic when it contains too many ketones. An excess of ketones in the blood produces a condition known as ketoacidosis. In diabetics, the condition is often referred to as diabetic ketoacidosis, or DKA.
Ketoacidosis is usually rare in type 2 diabetics. When it occurs, however, it can be life-threatening. According to the American Diabetic Association, ketoacidosis “is a serious condition that can lead to diabetic coma or even death.”
On May 15, 2015, the FDA warned patients that Invokana and certain other SGLT2 inhibitors might lead to ketoacidosis. The FDA’s warning followed its discovery of 20 cases in which patients were hospitalized for DKA between March 2013 and June 2014 while taking a SGLT2 inhibitor. Since DKA is rarely observed in type 2 diabetics, SGLT2 inhibitors are the most likely cause of DKA’s appearance in those patients.
The FDA warning indicates that more reports of DKA in patients who are taking SGLT2 inhibitors have surfaced since June 2014. While the FDA has not yet taken additional action, it has cautioned patients who take SGLT2 inhibitors to watch for signs of ketoacidosis and to seek medical advice immediately if those symptoms appear.
Other drugs in the class of SGLT2 inhibitors covered by the FDA warning are dapagliflozin (marketed by AstraZeneca as Farxiga) and embagliflozin (marketed by Eli Lilly and Boehringer as Jardiance). The FDA is continuing to gather data and may decide to require drug manufacturers to issue a formal warning as they continue to market Invokana and other SGLT2 inhibitors.
Symptoms of Ketoacidosis
If you take Invokana, you should be aware that any of the following symptoms may be caused by ketoacidosis:
- frequent urination
- a very dry mouth or unquenchable thirst
- shortness of breath or difficulty breathing
- dry or flushed skin
- a fruity odor on your breath
- nausea or vomiting
- abdominal pain
- unusual fatigue or sleepiness
Vomiting is a particularly important symptom. Ketoacidosis often becomes life-threatening after a patient experiences prolonged vomiting. If you are taking Invokana and experience an episode of vomiting that lasts more than two hours, you need to obtain medical attention immediately.
The FDA has cautioned patients not to discontinue their use of Invokana unless advised to do so by a doctor. Rather, diabetics who are taking Invokana should discuss the risks and benefits with their physician. Make sure, however, that your doctor is familiar with the FDA warning.
If you experience symptoms of ketoacidosis and are using Invokana, tell your doctor immediately. If you doctor seems to be unconcerned or unfamiliar with the FDA warning, consider getting a second opinion. You can also ask your doctor for a ketone test, which is a fast and simple test of the urine. Other diabetic medications may be more suitable for you if the test reveals that you have elevated ketone levels.
Additional Risks – Kidney Failure, Coma, Stroke and Heart Attack
In addition to ketoacidosis, Invokana patients should be aware of the possibility of additional risks associated with this medication. During clinical trials, 13 patients taking Invokana experienced major cardiovascular events (heart attacks and strokes). This is in contrast to only one patient in the placebo group. Patients who have taken Invokana and experienced a heart attack, stroke, kidney failure, or diabetic coma, should contact an injury attorney right away to preserve his or her rights.
Compensation for Injuries Caused by Invokana
If you or a family member took Invokana and were hospitalized after developing ketoacidosis, or after having suffered a heart attack, stroke, kidney failure, or diabetic coma, you may be entitled to compensation. Drug manufacturers frequently market drugs without completing adequate testing to assure their safety. In other cases, they are aware of potentially dangerous side effects but they fail to warn patients (and their doctors) that those side effects might occur.
The Institute for Safe Medication Practices reports that Invokana was not tested in a sufficiently large population for a sufficient length of time to assure its safety before it was released. Patients may now be experiencing the harm that results from incomplete testing data.
Compensation for injuries caused by Invokana may include reimbursement of lost income and medical expenses incurred to treat the illness, as well as compensation for pain and suffering, emotional anguish, and loss of enjoyment of life. Wrongful death damages may be available to family members of a patient who died as a result of taking Invokana. Since there are strict time limits for making compensation claims against a pharmaceutical company, contact a personal injury lawyer immediately so that your claim can be evaluated before you lose the right to seek compensation. The attorneys at Advocate Law Group have decades of experience handling product liability and personal injury claims. We work with leading product liability firms nationwide to help our clients obtain results. Contact us for a free case evaluation.