Diabetics May Seek Compensation for Ketoacidosis Caused by Invokana
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UPDATED: Jul 16, 2015
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Diabetics who were hospitalized with ketoacidosis after taking Invokana may be entitled to compensation. Invokana, known by the generic name canagliflozin, belongs to a class of drugs called SGLT2 inhibitors. A recent warning by the Food and Drug Administration (FDA) suggests that SGLT2 inhibitors cause a dangerous increase in the amount of acid carried in a patient’s blood, producing a life-threatening condition known as ketoacidosis.
Diabetes and SGLT2 inhibitors
Diabetes is a disease that results in too much blood sugar (glucose). Glucose is one of the body’s essential fuels. When food is digested, glucose is released into the bloodstream and absorbed into cells, producing energy and growth.
The pancreas manufactures insulin to help cells absorb glucose. The cells in diabetics who suffer from the most common form of the disease, type 2 diabetes, do not respond properly to insulin, leaving too much glucose in the blood. That condition can create a variety of health complications that include heart problems, hypertension, hearing and visual impairments, nerve damage, kidney disease, and other disorders.
Known formally as sodium-glucose cotransporter 2 inhibitors, SGLT2 inhibitors prevent kidneys from filtering glucose and returning it to the body’s bloodstream. By forcing kidneys to release glucose from the body in urine, SGLT2 inhibitors reduce the body’s supply of blood sugar. Drugs such as Invokana are therefore seen as beneficial to type 2 diabetics when used in combination with exercise and diet.
The Food and Drug Administration approved Invokana for sale in 2013. Marketed by Janssen Pharmaceuticals, Invokana is the most widely prescribed of the SGLT2 inhibitors, with sales in excess of $278 million in the first quarter of 2015. Other SGLT2 inhibitors are dapagliflozin, which AstraZeneca markets as Farxiga, and empagliflozin, marketed as Jardiance by Eli Lilly and Boehringer.
Risks and benefits of Invokana
In its May 2014 Quarterly Report, the Institute for Safe Medication Practices (ISMP) asked whether the risk of taking Invokana outweighs its benefits. At that time, known risks included kidney damage, urinary tract infections, and abnormal weight loss. When the ISMP reported that data to Janssen Pharmaceuticals, the drug company responded that its patient warnings covered most of those issues. The warnings do not, however, mention the risk of developing ketoacidosis.
Given the limited testing of Invokana prior to wining FDA approval, the ISMP questions whether the risks of Invokana outweigh its benefits. It raised that question a year before the FDA issued its warning about the potential link between Invokana and ketoacidosis.
Ketoacidosis and the FDA warning
The FDA based its warning on a study of its database of reported adverse reactions to medications. Over a 15 month period that ended in June 2014, the FDA received reports that 20 diabetics who took a SGLT2 inhibitor had been hospitalized with ketoacidosis. The FDA continued to receive “adverse event” reports linking SGLT2 inhibitors to ketoacidosis after June 2014.
Ketoacidosis is a condition characterized by a buildup of ketones in the blood. It occurs when the body relies on fat for energy because it cannot use glucose. As fat breaks down, it produces waste products called ketones. While ketones can be a source of energy, ketones are derived from fatty acids. When they accumulate, they can make the body’s blood supply dangerously acidic.
Ketoacidosis is a life-threatening condition. Symptoms include:
- stomach pain
- muscle pain
- loss of alertness
- extreme thirst
- frequent urination
- nausea and vomiting
- fruity smelling breath
Frequent and extended vomiting is a sign that the condition has reached a dangerous stage. If you suspect that you are suffering from ketoacidosis, you should regard your condition as a medical emergency.
Ketoacidosis is easily detected by a blood test. Treatment for the condition often requires hospitalization. If left untreated, ketoacidosis can lead to severe illness, prolonged loss of consciousness (coma), and death.
Compensation for ketoacidosis caused by Invokana
The FDA warning indicates that SGLT2 inhibitors like Invokana may cause ketoacidosis. The FDA is continuing to investigate that risk. It may eventually require drug companies to warn diabetics of the potentially dangerous side effect of taking those medications. It could also decide to remove Invokana from the market.
At this point, the evidence raises questions as to whether drug companies knew or should have known that Invokana and similar drugs are linked to ketoacidosis. The evidence also raises questions as to whether those pharmaceutical companies should have warned doctors and their patients so that they could make a fully informed assessment of the risks and benefits of using Invokana.
If you took Invokana or another SGLT2 inhibitor and developed ketoacidosis, you may have a claim for compensation. The medical expense of hospitalization and treatment, lost income while recovering from the condition, and your pain, suffering, and emotional distress are all included in the measurement of compensation that you might be entitled to receive.
Each case must be evaluated by a personal injury lawyer who represents clients in claims against pharmaceutical companies. If the claim has merit, it should be pursued by an attorney who has experience handling these difficult cases. Keep in mind that the time for making a claim is limited by law. If you do not act promptly, you may lose your right to seek compensation. Consult with a knowledgeable personal injury attorney immediately if you were diagnosed with ketoacidosis after taking Invokana.