What is Invokana?
Invokana (canagliflozin) is in a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors include other prescription medications such as Farxiga and Glyxambi that are used to help regulate blood sugar levels in adult patients with type 2 diabetes.
According to the Mayo Clinic, type 2 diabetes is a condition that impairs the body’s ability to make use sugar (glucose) as an energy source. Insulin is a hormone that helps cells absorb glucose from the bloodstream to use it as a source of energy, but in patients affected by this disease, its effects are substantially reduced. Because of that, sugar stays in the blood until its levels become high enough to cause health complications.
Like other SGLT2 inhibitors, Invokana works by forcing the kidneys to extract sugar from the blood and expel it through the urines. This class of drugs, however, is not approved to treat type 1 diabetes patients.
Why is Invokana Dangerous?
On May 15, 2015, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding all 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 lead to hospitalization.
Additional risks associated with canagliflozin 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 diabetic ketoacidosis (DKA) and ketosis in patients treated with this antidiabetes agent from March 2013 to June 6, 2014. All patients required emergency room visits or hospitalization for urgent treatment.
Since June 2014, the FDA has continued to receive additional reports for DKA in patients treated with SGLT2 inhibitors.
In May 2016, the regulatory agency 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 (a life-threatening condition) related to the use of certain type 2 diabetes medications, including Invokana. According to the report, the regulator received reports of 101 confirmable cases of acute renal damage, as reported to FAERS from March 2013 to October 2015.
Patients who have suffered severe side effects from the drug may be eligible to file an Invokana lawsuit and seek compensation for their injuries.
Lauren A. on May 16, 2016
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Why you should file an Invokana Lawsuit?
Filing an Invokana lawsuit may be an option for diabetes patients who suffered ketoacidosis, amputations, kidney failure and other severe side effects after taking the drug. The drug manufactured and sold by Johnson & Johnson has been allegedly linked to aseveral life-threatening risks of which the public was never adequately informed about. Renal damage, heart attacks, other cardiovascular issues and DKA might have permanent or even fatal consequences on patients who suffer them, and lawyers allege that the drug’s label failed to appropriately address these risks.
Affected patients and their loved ones may be able to bring their case in front of a federal court and request compensation with the help of a dangerous drug attorney.
For more information, contact Attorney Group. We will help you by providing all the legal assistance you need to fully understand your options. If you’re eligible to file a claim, we will connect you with the best law firm available to assist you with your particular needs.
Invokana and SGLT2 Inhibitors Side Effects
Invokana, like many drugs, can come with a number of side effects, ranging from common to rare. The most common of them include:
- Low blood sugar
- Frequent urination
- Urinary tract infection
More infrequent adverse reactions 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 side effects include kidney disease, pancreatitis, hives and stomach cramps.
Other SGLT2 inhibitors are marketed under various brand names and are manufactured by drug makers Janssen, AstraZeneca and Boehringer Ingelheim.
Brand names/generic names and active ingredients 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
All these drugs can come with risks, especially when combined with another diabetes medication.
What is Invokana Ketoacidosis?
Diabetic ketoacidosis, or DKA, is a serious and in some instances fatal condition. In patients who 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. These substances can accumulate in the blood, posing a danger to the body and potentially requiring hospitalization.
According to the American Diabetes Association, When low blood sugar is combined with dehydration, shock, and fatigue, ketoacidosis can lead to a diabetic coma if left untreated.
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, however, 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 them.
The regulator’s Safety Communication has set forth the risks of the drugs, and have provided the ground for lawyers who allege that drugmakers failed to adequately warn the public about them. Failure to warn of side effects of a medication can be a basis of a product injury liability, regardless of whether the drug has been recalled.
Current state of the legal proceedings
So far, most of the other SGLT2 medications lawsuits are in their early stages, but the cases of plaintiffs who sued the manufacturers after suffering an Invokana side effect keep growing day after day.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized almost one thousand claims in the New Jersey multidistrict litigation (MDL) No. 2750, overseen by Judge Brian R. Martinotti.
To help the parties understand how the mass tort litigation might play out, several bellwether trials have been set. The results of these initial trials often determine whether the pharmaceutical company might wish to pay a settlement to plaintiffs to avoid being submerged by legal expenses.
Invokana bellwether trials have been scheduled for September 2018. Judge Martinotti has directed the parties to identify a total of six plaintiffs who suffered from kidney injury and other six who suffered from ketoacidosis. Other cases that include different type of injuries such as foot and leg amputation might be set later.
Have You Seen an Invokana Lawsuit Commercial?
You may have seen an Invokana lawsuit commercial on television and wondered if you’re eligible to receive a financial reward for all the damage you or your loved ones may have suffered. We at Attorney Group strive to provide you with all the information you need to understand your options and make an informed choice.
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 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. A few months earlier, the regulator released information that these drugs may decrease bone density among patients using them and also increase the overall risk of bone fracture development.
- June 2014The FDA identifies 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis linked to SGLT2 inhibitor use.
- January 2014A second SGLT2 inhibitor, dapagliflozin, gets approved.
- 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.