An Invokana lawsuit may be an option for diabetes patients who suffered ketoacidosis and other severe side effects after taking the drug. Invokana, manufactured and sold by Johnson & Johnson, has been allegedly linked to an increased risk of kidney failure, heart attacks, other cardiovascular issues and ketoacidosis, which is characterized by dangerously high blood acid levels. Affected patients and their loved ones may be able to file a lawsuit and recover compensation with the help of a dangerous drug attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Invokana lawsuit attorney who can assist you throughout the legal process.
Have You Seen an Invokana Lawsuit Commercial?
You may have seen an Invokana lawsuit commercial on television and wondered whether you or a loved one have been affected by Invokana or other SGLT2 inhibitors and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Invokana?
Invokana, which contains the active ingredient canagliflozin, is in a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors includes other drugs such as Farxiga and Glyxambi that are used to help regulate blood sugar levels in adult patients with type 2 diabetes.
This class of drugs, however, is not approved to treat type 1 diabetes patients. Along with other members of the SGLT2 inhibitor class, Invokana works by triggering the kidneys to take sugar from the body through the urine to lower blood sugar levels.
Other SGLT2 inhibitors are marketed under various brand names names and are manufactured by drug makers Janssen, AstraZeneca and Boehringer Ingelheim.
Brand names/generic names and active ingredients for affected SGLT2 inhibitors include:
- Invokana/Canagliflozin, containing canagliflozin
- Invokamet/Canagliflozin and Metformin, containing canagliflozin and metformin
- Farxiga/Dapagliflozin, containing dapagliflozin
- Xigduo XR/Dapagliflozin and Metformin ER, containing dapagliflozin and metformin extended-release
- Jardiance/Empagliflozin, containing empagliflozin
- Glyxambi/Empagliflozin and Linagliptin, containing empagliflozin and linagliptin
These kinds of drugs can come with risks, including ketoacidosis, kidney complications, dehydration, higher blood cholesterol levels, and low blood sugar when an SGLT2 inhibitor is combined with another diabetes medication.
Lauren A. on May 16, 2016
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How Does Invokana Work?
According to the Mayo Clinic, type 2 diabetes is a condition that affects the body’s ability to break down sugar (glucose) as an energy source. Insulin is the body’s means of breaking down sugar in the blood for its cells to have energy, and type 2 diabetes either causes the body to resist the effects of insulin, or to produce inadequate amounts. If glucose levels in the blood are too high, it can be dangerous and cause health complications. Like other SGLT2 inhibitors, Invokana works by triggering the kidneys to take sugar from the body through the urine to lower blood sugar levels.
On May 15, 2015, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding SGLT2 inhibitors, including Invokana, on the basis that the drugs may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
Invokana risks may include the following injuries or complications:
- Ketoacidosis, which may lead to diabetic coma or death
- Cardiovascular complications
- Kidney damage or failure
- Bone fracture risk
- Decreased bone mineral density
As of May 2015, the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All patients required emergency room visits or hospitalization for treatment.
Since June 2014, the FDA has continued to receive additional reports for DKA in patients treated with SGLT2 inhibitors.
In May 2016, the FDA issued a drug safety communication reporting that “interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).”
In June 2016, the FDA issued a safety communication strengthening an existing warning regarding the risks of acute kidney injury related to the use of certain type 2 diabetes medications, including Invokana. According to the report, the FDA received reports of 101 confirmable cases of acute kidney injury, as reported to FAERS from March 2013 to October 2015. Some cases reported incidences of hospitalization.
Patients who have suffered severe side effects from the drug may be eligible to file an Invokana lawsuit and seek compensation for their injuries.
Invokana Side Effects
Invokana, like many drugs, can come with a number of side effects, ranging from common to rare. More common Invokana side effects, according to WebMD, can include:
- Low blood sugar
- Frequent urination
- Urinary tract infection
More infrequent Invokana side effects include:
- Low blood pressure
- Faintness or weakness
- High levels of magnesium in the blood
- High levels of potassium in the blood
- Allergic reaction
- Dry mouth
- High levels of cholesterol
- High levels of hemoglobin
Rare Invokana side effects include kidney disease, pancreatitis, hives and stomach cramps.
Due to the FDA safety communication regarding SGLT2 inhibitors, including Invokana, Invokana ketoacidosis claims may be filed that allege the drug maker failed to disclose risks of ketoacidosis associated with the drug.
Ketoacidosis is also known as diabetic ketoacidosis, or DKA. For bodies that lack adequate amounts of insulin, certain hormones begin to break down fat as an alternative source of energy, which causes the production of toxic acids called ketones. Ketones can accumulate in the blood, posing a danger to the body and potentially requiring hospitalization.
According to the American Diabetes Association, ketoacidosis can lead to a diabetic coma if left untreated, which may result in Invokana coma claims being filed. When low blood sugar is combined with dehydration, shock, and fatigue, it could result in a diabetic coma, or even death.
Signs and symptoms of DKA, according to the Mayo Clinic, typically develop quickly, and can include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Fruity-scented breath
DKA can be triggered by factors such as heart attack, emotional or physical trauma, surgery, high fever, stress, or alcohol or drug abuse.
Has There Been an Invokana Recall?
As of January 2017, there is no known recall of Invokana or other SGLT2 inhibitors. The FDA’s Safety Communication, however, has set forth the risks of the drugs, and Invokana lawsuits allege that drug makers failed to adequately warn of the dangers associated with the drug.
According to the FDA, patients who take Invokana or other SGLT2 inhibitors should pay close attention for any signs and symptoms of acidosis and that ketoacidosis related to the use of SGLT2 inhibitors may be present even if blood sugar levels are not very high.
The FDA has advised healthcare professionals to inform patients and caregivers of the signs and symptoms of metabolic acidosis, such as tachypnea or hyperventilation, anorexia, abdominal pain, nausea, vomiting, lethargy, or mental status changes, and instruct them to seek medical attention immediately if they experience the signs or symptoms.
Additionally, an Invokana lawsuit claims that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Have There Been Invokana Lawsuit Settlements?
Some cases settle early in the claims process, but it is not expected that there will be early Invokana settlements. In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time, initial trials known as bellwether trials take place.
The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
It is expected that Invokana settlements will follow this pattern, although the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Invokana Lawsuit News
- May 2017FDA issues new drug safety communication confirming increased risk of leg and foot amputations with Invokana. According to the alert, the agency is requiring new warnings to the drug's labeling information to describe the risk.
- January 2017Federal judge issues case management order announcing that a special mediator will coordinate pre-trial proceedings as well as the discussion of any potential settlements.
- December 2016Lawsuit claims that the manufacturers of Invokana failed to provide adequate warnings regarding the risk of kidney complications related to the use of the medication.
- December 2016The Judicial Panel on Multidistrict Litigation issues transfer order, centralizing all federal Invokana lawsuits and moving them to the U.S. District Court for the District of New Jersey.
- July 2016Invokana lawsuit alleges that the plaintiff, after beginning treatment with the medication, developed diabetic ketoacidosis. Additionally, the drug manufacturer failed to provide an adequate warning to consumers and/or their health care providers of the defects of the drug.
- June 2016The FDA issued a safety communication strengthening an existing warning regarding the risks of acute kidney injury related to the use of certain type 2 diabetes medications, including Invokana
- May 2016The FDA issues a drug safety communication reporting that “interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).”
- April 2016Reports that the FDA has released information that Invokana and other SGLT2 inhibitor class drugs may decrease bone density among patients using them and also increase the overall risk of bone fracture development.
- February 2016An Invokana lawsuit alleges that the drug caused keotacidiosis and other severe side effects.
- May 2015FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood.
- June 2014The FDA identifies 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis linked to SGLT2 inhibitor use.
- January 2014The FDA approves a second SGLT2 inhibitor, dapagliflozin.
- March 2013Canagliflozin (Invokana) becomes the first SGLT2 inhibitor to be approved by the FDA.
How an Invokana Lawsuit Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Invokana may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.