The lawsuits involving Invokana state 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.
What is the Purpose of Invokana
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.
Invokana is an antidiabetic drug of the subtype 2 sodium-glucose transport (SGLT-2) inhibitors class. It helps improve glycemic control in patients with type 2 diabetes, and it’s often used in combination with other drugs such as metformin or sulfonylureas.
Patients affected by type 2 diabetes slowly become more and more resistant to the effects of insulin, a hormone required by cells to properly use glucose (blood sugar). Since cells cannot use sugar anymore, it starts reaching toxic levels in the blood, leading to a condition called hyperglycemia.
Many antidiabetic medications act by reducing the serum sugar levels or by improving the effectiveness of insulin itself. SGLT-2 inhibitors mechanism of action is a quite peculiar one. They block glucose kidney reabsorption, meaning that the sugar that reaches the kidney cannot go back to the blood and is thus eliminated through the urines.
Sugar removed this way amounts to an average of about 119 grams (476 kilocalories) per day. Since the glucose molecule possesses osmotic properties, additional water is excreted through diuresis reducing blood pressure.
Difference between Type 1 and 2 Diabetes
Type 1, also known as “childhood onset,” is a genetic condition in which the patient’s pancreas fails to produce insulin. Essentially, the organ does not function.
Type 2 is also known as “adult onset.” While some people are genetically predisposed to this condition, it is largely caused by lifestyle issues, such as obesity, excess consumption of sugar and lack of physical activity. While the pancreas is usually fully functional, the body’s cells have stopped responding to insulin. The condition is known as “insulin resistance.”
Invokana Injuries & Side Effects
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.
Is Invokana Safe During Pregnancy
Invokana has been classified by the FDA as pregnancy risk category C. Although no human tests are available to assess its risks, in rat fetuses this drug damaged kidney development. Traces of this drug were found in the milk of lactating rats, meaning that breastfeeding mothers should talk to their doctors before taking it.
On September 2015, the FDA modified the drug’s label to warn patients about a possible risk of bone fractures. Clinical studies showed an increased occurrence of fractures as early as 12 weeks after treatment initiation. The drug has also been linked to decreases in bone mineral density at the hip and lumbar spine, causing the bones to break even after a minor trauma is sustained.
Invokana Lawsuit Videos
Invokana Lawsuit News
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
A blockbuster diabetes drug called Invokana has pulled in hundreds of millions of dollars for big pharma, but the FDA recently announced that the treatment is causing even more problems with diabetics, but the FDA are the people who allowed that to happen. Joining me now to explain what’s happening is Tim O’Brien. Tim, a dysfunctional FDA has allowed it to happen again. It seems like every week we’re talking about a new blockbuster drug that’s killing people by the blockbuster thousands. Invokana is no different. To read more, click The Ring of FireSGLT2 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
For additional information, click Levin Law Invokana News
FDA and Scientific Studies Regarding Invokana
FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga & Xigduo XR"The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)." To read more, click FDA Drug Safety
FDA revises labels of SGLT2 inhibitors [including Invokana] to include warnings about too much acid in the blood and serious urinary tract infections"Patients 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." 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 Settlement Information
As of this time, there have been no large group settlements involving Invokana and the potential link to kidney and heart injuries. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.