The lawsuit involving Invokana states the manufacturer failed to warn patients and physicians of the increased risks of kidney failure, myocardial infarction (heart attacks), and ketoacidosis. Plaintiffs attorneys argue that if the manufacturer had properly warned, then doctors would have prescribed a medication other than Invokana for patients with type 2 diabetes, and certainly patients would have had their health monitored on a more frequent basis for potential signs of heart issues, renal impairment, and high level of ketones.
Why is Invokana Prescribed
Invokana is a prescription medication used in combination with diet and exercise to lower blood sugar and improve glycemic control in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and a range of other problems. Invokana helps lower a person's blood sugar by causing the kidneys to remove sugar through the urine.
Side Effects of Invokana
The most serious potential side effects and risks caused by Invokana are myocardial infarction (heart attack), kidney damage and ketoacidosis.
Kidney failure occurs when your kidneys stop functioning without the use of dialysis or a kidney transplant. Kidneys help filter waste products from the blood. They are also involved in helping to control blood pressure, electrolyte balance, and red blood cell production. When your kidneys stop functioning properly, waste products, fluids, and electrolytes build up in the body and can cause weakness, shortness of breath, lethargy, confusion, abnormal heart rhythms and sudden death.
Myocardial infarction (commonly known as a heart attack) is the irreversible death of cells within the heart caused by a restriction of blood. It occurs when there is a blockage in the arteries preventing blood from reaching portions of the heart, and thus oxygen and nutrients no longer reach the heart muscle. Basically a portion of the heart is being starved of oxygen and nutrients, a condition called "cardiac ischemia." If this condition lasts too long, the starved heart tissue dies.
Ketoacidosis is a medical condition where high levels of ketones are produced in the body. Ketoacidosis can result in a patient suffering a diabetic coma, extended hospitalization, and even death. Ketoacidosis develops when the body is unable to produce enough insulin, which insulin plays a major role in helping sugar (glucose) enter cells, and provides needed energy to the muscles and other tissues. Without enough insulin, the body breaks down fat as an alternative source of energy, which causes a buildup of toxic acids in the bloodstream called ketones. Excess ketones result in ketoacidosis if untreated.
If you are currently taking Invokana, you should pay close attention for any signs of kidney failure, heart problems and acidosis and seek immediate medical attention if you experience symptoms such as chest pain, dizziness, faintness, increased heart rate, increased pulmonary rate, difficulty breathing, hyperventilation, weakness, changes in urination, anorexia, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medication without first talking to your medical provider, but be especially careful to take appropriate measures to monitor for signs of kidney issues, heart problems, and acidosis, and immediately seek appropriate medical care if you have any concerns.
Invokana Lawsuit Videos
Invokana Lawsuit Videos
FDA and Scientific Studies Regarding Invokana
FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors [such as Invokana] for diabetes to include warnings about too much acid in the blood and serious urinary tract infectionsPatients should stop taking their SGLT2 inhibitor [such as Invokana] and seek medical attention immediately if they have any symptoms of ketoacidosis, 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. Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine. Contact a health care professional if you experience any of these symptoms. To read more, click FDA Drug Safety
FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the bloodThe U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. To read more, click FDA Drug Safety
Invokana Recall Information
As of this time, there has not been a recall of Invokana related to kidney failure, myocardial infarction or ketoacidosis. However, the U.S. Food and Drug Administration has issued two safety announcements warning patients to stop taking Invokana, and seek immediate medical help, if they suffer any symptoms of ketoacidosis, such as nausea, vomiting, abdominal pain, tiredness, or trouble breathing.
Invokana Lawsuit NewsManufacturer of Invokana Admits Link to Acute Kidney Injuries:
Janssen is now expressly warning that acute kidney injuries are associated with using Invokana. In light of the mounting litigation over claims that Invokana causes kidney failure and other kidney injuries, it seems as though Janssen has read the tea leaves, and knows that a label change, whether voluntary or FDA-mandated, was needed.. To read more, click Drug Safety NewsPerspective: SGLT2 inhibitors may predispose to ketoacidosis:
Based on the physiology of SGLT2 and pharmacology of SGLT2 inhibitors, there are several biologically plausible mechanisms whereby this class of drugs has potential to increase the risk of developing diabetic ketoacidosis. Future research should be directed toward identifying which patients are at greatest risk for this side effect, and also to optimizing pharmacotherapy in order to minimize risk to patients. To read more, click The Journal of Clinical Endocrinology & Metabolism
Much of the recent bad news surrounding the new “miracle” diabetic drug Invokana (canagliflozin) has to do with a condition known as ketoacidosis, which can cause a dangerous rise in blood acidity. This in turn can lead to coma and even death. However, there is another increasingly apparent problem with this drug; and there is powerful evidence that both the drug maker and the FDA were aware of it. That issue is the risk of Invokana myocardial infarction (heart attacks). To read more, click Levin Law NewsThe Invokana Kidney Damage and Ketoacidosis Lawsuit – The Beginning is Now Officially Upon Us:
Invokana (canagliflozin) is the latest in a line of drugs designed to treat Type 2 (adult-onset) diabetes. Like its predecessors, glitazone (Actos, Avandia) and sitagliptin (Januvia), it has been implicated in a number of adverse events that have resulted in patient health complications, hospitalizations and even death. To read more, click Levin Law NewsSGLT2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: FDA:
The US Food and Drug Administration (FDA) warned today that sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to ketoacidosis requiring hospitalization. The warning includes the SGLT2 inhibitors canagliflozin (Invokana, Johnson & Johnson), dapagliflozin (Farxiga, AstraZeneca), and empagliflozin (Jardiance, Lilly/Boehringer), as well as three combination products that include an SGLT2 inhibitor: canagliflozin plus metformin (Invokamet, Johnson & Johnson), dapagliflozin plus metformin extended release (Xigduo XR, AstraZeneca), and empagliflozin plus linagliptin (Glyxambi, Lilly/Boehringer). To read more, click Medscape NewsFDA Issues Warning for Type 2 Diabetes Drugs: SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis:
A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns. These prescription drugs are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine. The drugs are sold under the brand names: Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin). To read more, click WebMD