Invokana

July 9, 2015

Invokana (Invokamet) Litigation

InvokanaInvokana drug litigation will address whether manufacturers failed to warn patients and physicians of the increased risks of kidney failure, myocardial infarction (heart attacks), other cardiovascular issues and ketoacidosis.  Invokana litigation will address the issue that had the manufacturers and marketers properly warned of the risks, patients could have been prescribed and taken a substitute medication for their diabetes, or had their health monitored on a more routine basis for potential signs of heart issues, renal function impairment and high ketone levels.

What is the Prescription Drug Invokana (Invokamet) and Why is it Prescribed

Invokana (Invokamet) is a SGLT2 inhibitor used in combination with diet and exercise to improve glycemic control and lower blood sugar in adults with type 2 diabetes mellitus. 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. Diabetes is the seventh leading cause of death in the U.S. SGLT2 inhibitors lower a person's blood sugar by causing the kidneys to remove it through the urine.

What are the Different SGLT2 Inhibitors Being Investigated for Increased Risks of Kidney Failure, Myocardial Infarction and Ketoacidosis

The following brand name prescription medications are being investigated for a potential increased risk of kidney failure, myocardial infarction and ketoacidosis:

Brand Name

Active Ingredients

Invokana

Canagliflozin

Invokamet

Canagliflozin and Metformin

Farxiga

Dapagliflozin

Xigduo XR

Dapagliflozin and Metformin extended-release

Jardiance

Empagliflozin

Glyxambi

Empagliflozin and Linagliptin

What are the Possible Side Effects, Complications and Risks of Invokana (Invokamet)

The most serious potential side effects, problems and risks caused through the use Invokana (Invokamet) 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 regulating blood pressure, electrolyte balance, and red blood cell production. When your kidneys stop properly functioning, 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 necessary 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 process produces a buildup of toxic acids in the bloodstream called ketones. Excess ketones result in ketoacidosis if untreated.

If you are currently taking Invokana (Invokamet) or another SGLT2 inhibitor (such as Farxiga, Xigduo XR, Jardiance or Glyxambia), 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, lethargy and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines 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.

Before taking Invokana (Invokamet), or if you presently are taking Invokana (Invokamet), make sure to tell your doctor if any of the following factors apply to you, as they increase your likelihood of having medical problems by taking Invokana (Invokamet): (1) kidney disease; (2) liver disease; (3) heart disease; (4) high blood pressure; (5) low blood pressure; (6) an electrolyte imbalance (such as high levels of potassium in your blood); (47) high cholesterol; (8) if you are on a low salt diet; or (9) if you use insulin or other oral diabetes medicines. It is unknown whether Invokana can harm a fetus or an infant being breastfed. Make sure to talk to your doctor if you plan to become pregnant, are pregnant or are breastfeeding.

Has There Been a Recall of Invokana (Invokamet) Resulting From any Association with Kidney Failure, Myocardial Infarction or Ketoacidosis

As of this time, there has not been a recall of Invokana (Invokamet) related to kidney failure, myocardial infarction or ketoacidosis. However, the investigation into this drug, from a legal standpoint, is still at its early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that may lead to a voluntary or involuntary recall. However, the U.S. Food and Drug Administration has issued a safety announcement asserting that patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.

Have There Been Any Invokana (Invokamet) Settlements

We are actively investigating problems associated with these drugs.  Every day we are finding more troubling information regarding the correlation between Invokana (Invokamet) and kidney failure, cardiovascular issues and ketoacidosis, and the failure of the manufacturer and marketers to adequately warn of these dangers to the doctors and patients.

Litigation like this takes many years to reach a possible settlement stage, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, individual, small or large group 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.  We are not there yet.  This in no way means you can wait to hire an attorney and file a lawsuit. Just the opposite, if you wait, you could permanently lose all of your rights, even if a settlement occurs in the future. This is because every state has time limitations in which you can file a lawsuit for any injuries that you have sustained or could sustain. This is known as the statute of limitations, as is more thoroughly discussed in the next section.

How Long Do I Have to File an Invokana (Invokamet) Lawsuit

Every state has maximum time limitations on when an injury claim must be filed. These time restrictions are known as statutes of limitations. If a claim is not filed against the manufacturer, marketers, retailers and healthcare providers before the statute of limitation expires, the injured persons are forever prevented from bringing a claim against the entities and persons who may be liable for their injuries.

If you have been potentially injured by the use of Invokana (Invokamet), your statute of limitations may already have expired, or may expire in the very near future. Unfortunately, there is no way for us to tell you without us first reviewing the individual facts of your situation. The one thing we can absolutely state is that every day you wait to retain an attorney may be the last day you can bring a claim.

Will Invokana (Invokamet) Litigation be a Class Action

Invokana (Invokamet) litigation likely will not proceed as a "class action." The term "class action" refers to a type of lawsuit whereby a small group of individuals represent the interests of a very large group of individuals. The small group actually pursues the litigation on behalf of the large group, and the results obtained by the small group are binding on the large group. Our law firm will not pursue class action litigation on behalf of our clients.

Instead, we will bring individual lawsuits on behalf of each of our clients. Most likely, the majority of our individual lawsuits will be combined before one judge in what is called multi-district litigation (MDL). The cases in a MDL are joined for purposes of discovery and investigation, and hopefully settlement. However, as part of a MDL, each individual case is separate, and no one client is forced to settle his/her case as part of a class action group, and no one is bound by the trials of others. Each client gets to make his/her own decision whether to go to trial or not.

FDA and Scientific Studies Regarding Invokana (Invokamet)

2015-05-15: FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood: The 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 (Invokamet) Litigation News

Perspective: 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

Invokana Litigation (Future Lawsuits): Cardiovascular Safety Concerns Were Expressed Early On: Much of the recent bad news surrounding the new 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 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 News.

The Invokana Kidney Damage and Ketoacidosis Litigation (Future Lawsuits) - 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 News

SGLT2 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 (Invokamet), 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 News.

FDA 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 (Invokamet) (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

Contact The Injury Lawyers At The Law Firm Of Hill, Peterson, Carper, Bee & Deitzler, PLLC

Our experienced attorneys are here to help by providing straightforward legal advice and aggressive legal representation. Contact us today at 304-205-1810 or 800-797-9730 to schedule a free initial consultation.