The Food and Drug Administration has issued new safety warnings about Invokana, an antidiabetic medication, which may increase the risk of severe urinary tract infection and diabetic ketoacidosis leading to kidney failure.
Invokana, the brand name for canagliflozin, is an antidiabetic agent used for the treatment of Type 2 diabetes. It may have been responsible for multiple cases of kidney failure due to severe urinary tract infection (UTI) or diabetic ketoacidosis. It may also increase the risk of heart attack and other serious side effects which may result in hospitalization, need for dialysis and may be life-threatening. Invokana lawsuits have been filed by multiple patients who experienced UTI or ketoacidosis leading to kidney failure and dialysis. The manufacturer, Janssen Pharmaceuticals and its parent, Johnson & Johnson, have been accused of failure to warn the medical community and the public about the risk of kidney failure and other dangers of Invokana.
Patients who experienced have experienced serious side effects including severe urinary tract infection, kidney failure, ketoacidosis, or heart attack after taking Invokana, may be eligible for compensation for their injuries.
Invokana (canagliflozin) is used to treat type 2 diabetes. It is a member of the SGLT2 (sodium-glucose co-transporter 2) inhibitor class of antidiabetic medication which decrease blood sugar by action on the kidney which causes excess glucose to be excreted through the urine.
The Risks of Taking Invokana
Invokana may cause a number of serious side effects including kidney failure and others that may be life-threatening.
Kidney Failure – The kidneys are responsible for filtering waste products from the bloodstream. They are also important for maintaining blood sugar and electrolyte levels and help to regulate fluid balance and blood pressure. When the kidneys are damaged by medications or toxins or become severely infected, they may stop functioning correctly. This may cause the buildup of waste products in the blood which results in a need for dialysis.
Invokana works to lower blood sugar by encouraging the kidneys to release excess sugar through the urine into the bladder. When sugar is present in the urine, the chance of developing a urinary tract infection is increased. Severe urinary tract infections may spread into the bloodstream and may damage the kidneys. Invokana may increase the chance of severe urinary tract infection and may increase the risk of kidney failure.
Symptoms of urinary tract infection usually include pain upon urination, urinary urgency, and urine that smells but it may progress quickly to a severe infection because Invokana increases the amount of sugar in the urine. More advanced symptoms may include flank pain (sides of lower back), fever, swelling and flu-like symptoms. Any unusual symptoms should be reported to a physician.
Ketoacidosis – In type 2 diabetics, the sugar in the blood is not available for the body to use as energy because insulin is not working correctly. Even though blood sugar levels are very high and may cause damage to body tissues, the cells are starved of energy which triggers the body to breakdown fat. This metabolism of fat, results in the production of an acidic substance known as ketones which when released in the blood, may have serious consequences. One of these consequences is an increased blood potassium level which may result in disturbance of blood pressure, heart rhythm, and muscle contraction, and may produce changes of consciousness.
Heart Attack – Also called myocardial infarction, heart attack occurs because the supply of oxygen to the heart muscle has suddenly been cut off. This often happens because of a sudden blockage in blood vessels and if the oxygen is not restored, heart muscle may die. Changes in electrolyte levels such as increased potassium levels, increased blood pressure and other conditions may increase the chance for heart attack.
If patients are taking Invokana or other SGLT2 inhibitors, they should seek medical attention when any symptoms of kidney failure, ketoacidosis, urinary tract infection or heart attack occur. Warning symptoms may include:
- dizziness, fainting
- extreme fatigue
- muscle weakness
- difficulty breathing, hyperventilation
- increased urination and thirst
- nausea, vomiting, abdominal pain
- increased heart rate
- chest pain
- urinary or flank pain
If any of these symptoms occur, the patient should stop taking Invokana and seek medical attention right away.
Women who are pregnant or intend to become pregnant should talk to their physician about Invokana risks before taking the medication.
Insulin is normally used by the body to transport glucose from the bloodstream into the cells where it can be used as energy. Type 2 diabetics have often become resistant to insulin and the sugar remains in the bloodstream. When the cells do not have sugar to provide energy, the body begins to break down fat.
Hundreds of patients who took Invokana may have experienced severe side effects due to the medication’s effects and may have caused kidney failure that required hospitalization and dialysis. Other patients have been injured by the increased risk of ketoacidosis or heart attack.
Hundreds of side effects caused by SGLT2 inhibitors, including Invokana, have been reported to the FDA. Some of these effects have been serious and resulted in hospitalization, kidney dialysis, and were potentially life threatening.
SGLT2 inhibitors which may have caused medical injury include:
- Invokana – canagliflozin
- Invokamet – canagliflozin and metformin
- Farxiga – dapagliflozin
- Xigduo XR – dapagliflozin and metformin
- Glyxambi – empagliflozin and linagliptin
Invokana (canagliflozin) was approved in March, 2013 and within two years, serious side effects were already being reported to the FDA. Some of these effects occurred shortly after the patient began taking Invokana. In May, 2013, the FDA issued the first Invokana safety warning. This initial warning stated that physicians and patients should be made aware of the increased risk for the development of the serious condition, diabetic ketoacidosis after taking Invokana.
On December 4, 2015, the FDA posted another safety warning on the agency website with additional information about Invokana including an increased risk of serious urinary tract infection which may result in kidney failure and a need for dialysis. The potential for kidney failure was specifically linked to urosepsis, a urinary tract infection that has become severe enough to infect the kidney and potentially spread into the bloodstream.
As part of the safety warning, the FDA has required that manufacturers of SGLT2 inhibitors including Invokana, add these warnings to the labeling and prescribing information. The companies are also being required to conduct additional post-marketing studies regarding the increased risk of ketoacidosis, kidney failure and other serious effects.
In addition to kidney failure and ketoacidosis, some patients have had other serious effects such as heart attack. Despite hundreds of serious adverse events reported to the FDA and many cases of medical injury, the company has not recalled Invokana and continues to market the medication.
Hundreds of Invokana lawsuits have already been filed by patients and their family members who were injured after taking Invokana. The manufacturer has been accused of failing to warn the public and the medical community about the increased risk of serious side effects of Invokana including severe urinary tract infection, kidney failure, ketoacidosis, heart attack and others.
If patients have experienced kidney failure, serious urinary tract infection, dialysis or hospitalization due to ketoacidosis, they may be eligible for compensation. Medical injury compensation may include treatment costs, future medical treatments, lost wages and pain and suffering. In some cases, plaintiffs are also eligible for punitive damages when the company knew about the dangers but promoted the medication anyway.
Patients who have been injured after taking Invokana may be eligible for compensation for medical treatment costs, future treatment costs, lost wages and pain and suffering. In addition, if the company can be shown to have known about the risks but failed to warn the medical community or public, they may be liable for punitive damages.
Though hundreds of Invokana and other SGLT2 lawsuits may have been filed in both the U.S. and Canada, many more are expected and no settlements have been announced yet. Each medical injury case is different and though previous antidiabetic lawsuits have resulted in hundreds of thousands of dollars in compensation, there are no guarantees. Each case must be evaluated separately by a legal expert.