A recent lawsuit in the U.S. has made some news with allegations of a drug company covering up data related to the dangers of Invokana, a diabetes medication that can cause ketoacidosis and other serious side effects
The “invokana mass tort settlement” is a lawsuit that has been filed against Invokana. The plaintiff claims that the company failed to warn them of the risks associated with taking Invokana.
(As of February 13, 2018)
Please note that we no longer accept Invokana and Invokamet cases.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a class of medications that have been authorized by the Food and Drug Administration (FDA) to treat low blood sugar in persons with type 2 diabetes.
Ketoacidosis and kidney damage have been connected to diabetes drugs like Invokana is a Japanese word meaning “to invoke” (canagliflozin).
However, the FDA has cautioned that SGLT2 inhibitors like Invokana might cause diabetic Ketoacidosis (DKA), which is characterized by high blood acid levels. SGLT2 inhibitors have also been linked to Fractures of the bones and renal damage, according to the FDA.
A number of manufacturers—including Johnson & Johnson, which makes Invokana—sell diabetic medications that are associated with harmful side effects.
Hundreds of lawsuits currently await trial against Invokana in federal and state courts. Plaintiffs argue that Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) misrepresented the risks of the medication and failed to warn patients about Invokana’s side effects.
What Are the Invokana Side Effects?
Ketoacidosis has been linked to Invokana and comparable medicines. There’s also evidence that the medications may lead to kidney damage, cardiac issues, Fractures of the bones, and other health issues.
Ketoacidosis
The American Diabetes Association lists the following symptoms of ketoacidosis:
- Breathing problems
- Nausea
- Vomiting
- Pain in the abdomen
- Confusion or inability to concentrate
- Unusual tiredness or drowsiness
- Skin that is dry or flushed
Kidney Damage
Invokana and related medicines may induce reduced renal function, according to adverse event statistics. The following are some of the adverse kidney effects related with these drugs:
- Failure of the kidneys
- Kidney problems
- Fluid imbalances/dehydration
- Stones in the kidneys
- Infections of the urinary tract
- Weight loss that is abnormal
In June 2016, the FDA introduced new kidney warnings for Invokana, Invokamet, Farxiga, and Xigduo XR, saying that the drugs were linked to adverse event reports of acute kidney injury that in some cases required hospitalization. Symptoms of kidney injury include decreased urine and swelling in the legs or feet. Some patients have filed Invokana Failure of the kidneys lawsuits, claiming that the manufacturer did not sufficiently warn of possible renal side effects.
Cardiovascular Consequences
The cardiovascular safety of Invokana was a point of contention among panel members before the medicine was authorized by the FDA. One clinical research found 13 cardiovascular (CV) events in the Invokana group compared to only one CV event in the placebo group, which raised concerns. Eight of the 15 members of the panel voiced misgivings about probable CV events, citing “concern with the rather small number of evidence to inform this risk” and “unresolved issues” about increased stroke and other events.
Other Issues to Consider
In addition to concerns over cardiovascular data, researchers have expressed concern over Invokana clinical research showing unsafe increases in low blood pressure symptoms and Infections of the urinary tract.
Dr. Sydney Wolfe of Public Citizen, a major consumer watchdog organization, testified before Congress in 2013 that the potential hazards of Invokana exceeded the potential benefits, and that the medicine should not be allowed.
Since then, additional safety organizations, such as the Institute for Safe Medication Practices (ISMP), have said that Invokana was not adequately examined in clinical studies at the time of FDA approval. The group questions whether the advantages of Invokana exceed the dangers, which is a key criterion for FDA approval.
Drugs like Invokana and SGLT2 have also been associated to:
- Cancers of the breast and bladder
- Pancreatitis
- Infections caused by yeast
- Fractures of the bones
Has the FDA issued any Invokana warnings?
The FDA has investigated hundreds of adverse event reports from individuals who were hospitalized after taking these medications.
The FDA issued a warning in May 2015 that SGLT2 inhibitors like Invokana might induce ketoacidosis, a disease in which the body creates excessive amounts of ketones (blood acids), causing the blood to become too acidic. According to the FDA, it has evaluated scores of adverse event reports from individuals who needed hospitalization after taking these medications.
The FDA amended the labeling of Invokana and Invokamet in September 2015 to add information concerning the risk of bone fractures and reduced bone mineral density. After the FDA ordered Janssen to do a post-marketing study after Invokana was authorized, the FDA amended the warning.
In June 2016, the FDA added a warning concerning SGLT2 renal side effects. The FDA issued the warning after receiving more than 100 adverse event reports. The EPA said at the time that renal side effects are likely underreported and may be more widespread than their limited data suggest.
The FDA issued a black box warning (the most serious warning it can issue) in May 2017 for the risk of toe, foot, and limb amputations. The warning was based on the findings of two clinical studies, which found that individuals with type 2 diabetes who used Invokana were twice as likely to need an amputation as those who took a placebo.
Which Medications Are Linked to Ketoacidosis?
Ketoacidosis and other serious side effects are possible with the following SGLT2 inhibitors:
- Invokana is a Japanese word meaning “to invoke” (canagliflozin)
- Invokamet (canagliflozin/metformin) is a drug that is used to treat diabetes.
- Jardiance is a term used to describe a person who (empagliflozin)
- Xigduo XR (dapagliflozin/metformin) is a combination of dapagliflozin and metformin.
- Farxiga is a fictional character created by Farxiga (dapagliflozin)
- Glyxambi (empagliflozin/linagliptin) is a drug that is used to treat diabetes.
Have Patients Who Have Been Injured Filed Lawsuits Against Janssen?
Patients with diabetes who used these medicines and were injured may be able to sue for medical expenditures, lost earnings, pain and suffering, and funeral expenses (in the case of a fatal injury).
Hundreds of cases are awaiting trial right now. A federal court panel in New Jersey merged these lawsuits into a multidistrict litigation (MDL) in December 2016.
Janssen might be held liable for a variety of things.
Liability for dangerous drug injuries typically falls on the companies that manufacture and market the drugs in question. For example, Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) sells Invokana and would be the primary target in a lawsuit. A lawsuit would have to prove that Janssen was in some way negligent in the manufacture and/or sale of Invokana. In other words, a successful lawsuit needs to show that Janssen did not do enough to protect the public from possible harm resulting from Invokana use.
Currently, lawsuits accuse Janssen Pharmaceuticals of doing one or more of the following:
- Keeping information from the FDA hidden
- Invokana’s hazards and advantages are being misrepresented.
- Failure to do necessary safety studies to assure the safety of the product
- Failure to alert patients about the dangers of Invokana
Who Was Eligible to File an Invokana Lawsuit?
A person who took Invokana (or a comparable medicine) and had ketoacidosis, renal damage, or another form of unanticipated harm might be eligible for an Invokana lawsuit. A patient’s mortality while using an SGLT2 inhibitor may potentially be grounds for legal action.
Frequently Asked Questions
Is there a lawsuit against Invokana?
A: No. There is no lawsuit against Invokana, but there are lawsuits against certain other prescription diabetes medications that contain nitrates.
Can Invokana cause DKA?
Why was Invokana taken off the market?
A: Invokana was taken off the market due to a large number of reports that the drug caused severe side effects, including kidney damage and death. A class-action lawsuit has also been filed against its manufacturer, Janssen Pharmaceuticals Inc., who is being accused of falsely downplaying or ignoring adverse reactions to their drugs.
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