What is Invokana?
Invokana (generic: canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to control blood sugar in patients with type 2 diabetes mellitus, a disease that affects nearly 30 million Americans (or almost 10% of the population) each year. The drug works by increasing the removal of glucose from the kidneys. Invokana was developed by Mitsubishi Tanabe Pharma, and is marketed under license by Janssen, a division of Johnson & Johnson.
SGLT2 Inhibitors May Cause Ketoacidosis: FDA Warning
On May 15, 2015, the FDA issued a Drug Safety Communication warning that Invokana and other SGLT2 inhibitors had been linked to diabetic ketoacidosis (also known as DKA, diabetic acidosis, metabolic ketoacidosis or ketoacidosis). Between March 2013 and June 6, 2014, at least 20 cases of DKA in patients who used these drugs were reported to the FDA’s Adverse Events Reporting System.
Ketoacidosis does not usually occur in type 2 diabetics, according to the FDA, and the reports were “atypical in that glucose levels were only mildly elevated at less than 200 mg/dL in some reports, while patients with type 1 diabetes who have DKA typically have glucose levels greater than 250 mg/dL.”
As a result of these problems, on Dec. 4, 2015, FDA announced new warnings to the products’ labeling regarding ketoacidosis and serious UTIs. The new labels will include information about the side effects, as well as prescribing and monitoring recommendations for healthcare providers.
Which Drugs are SGLT2 Inhibitors?
In addition to Invokana, other diabetes medications in the SGLT2 inhibitor class include:
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin and metformin hydrochloride extended-release)
- Difficulty breathing
- Abdominal pain
Invokana users with any of these symptoms should contact their doctor right away. However, FDA cautions that patients should never stop taking their diabetes medications without talking to their prescribing doctor first.
In all patients, DKA was diagnosed by a healthcare professional, and hospitalization was required to treat the problem. A link between ketoacidosis and SGLT2-inhibitor initiation was noted in all cases, according to the FDA. The median time to onset of symptoms after initiation of the drugs was 2 weeks (range, 1–175 days).
In most cases, a high anion-gap metabolic acidosis accompanied by elevated blood or urine ketones was noted. Potential triggering factors identified in some patients included acute illness changes, urosepsis, trauma, reduced caloric / fluid intake, and reduced insulin dose.
In addition to hypoinsulinemia, other factors that may have contributed to the development of a high anion-gap metabolic acidosis included hypovolemia, acute renal impairment, hypoxemia, reduced oral intake, and a history of alcohol use. However, in about half of the cases, no triggering factor could be found for the development of DKA.
Invokana Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure) / Kidney Cancer / Kidney Infections (Pyelonephritis) / Kidney Stones
- Amputations of the leg, foot, toe
- Bone Fractures / Bone Abnormalities
- Bone Fractures / Kidney Cancer
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
- Yeast Infections (both men and women)
Invokana Kidney Failure
Invokana lowers blood glucose levels by blocking the kidneys from reabsorbing glucose, causing some to be excreted from the body through the urine. However, it is believed that this same mechanism of action increases the risk of kidney problems and UTIs. Signs and symptoms of kidney failure include:
- Reduced amount of urine
- Swelling in the legs, ankles, and/or feet
- Unexplained shortness of breath
- Excessive drowsiness or fatigue
- pain / pressure in your chest
Urinary Tract Infections (UTIs)
Some of the most common side effects associated with Invokana are urinary tract infections (UTIs), which develop when bacteria travel though the urethra and into the bladder, causing an infection. Bacteria are more likely to develop in this area for people who take Invokana, because the medication expels sugar through the urine. The extra sugar presence can create additional bacteria. UTIs can be life-threatening when they spread into the kidneys and cause blood infections.
Another commonly reported side effect in Invokana users — both male and female — is the development of yeast infections (Candidiasis). The problem was first noted during pre-approval clinical trials, in 10% of women and 8% of men treated with the medication.
Yeast infections are caused by the overgrowth of a type of yeast called Candida, usually Candida albicans. This yeast is normally found in small amounts in the human body; however, Invokana can cause more yeast to grow, resulting in painful and sometimes dangerous symptoms.
The FDA warning comes just days after a quarterly report by the Institute for Safe Medication Practices (ISMP) questioned whether the potential risks of Invokana outweigh the benefits. The drug was approved in March 2013 despite concerns about side effects linked to it and other similar diabetes medications.
Invokana hit the market just as heart attack concerns were being raised about Avandia, bladder cancer was linked to Actos, and reports of pancreatic cancer were associated with the Byetta pen, Januvia, Janumet and Victoza. During the first year after Invokana was approved, ISMP found nearly 500 adverse event reports submitted to federal drug regulators, which is more than 92% of drugs monitored by the institute.
Many of the reports involved kidney failure / impairment (54 cases), UTIs (50 cases), dehydration / fluid imbalance (54 cases), kidney stones (11 cases) and abnormal weight loss (52 cases). Janssen told ISMP investigators that most of the injuries are known risks that are warned about on Invokana’s labeling; however, the ISMP report questions whether the benefits provided by the drug justify the risks.
According to the report, pre-approval clinical trials indicated that Invokana typically lowered levels of glycated hemoglobin (HbA1c), a primary type 2 diabetes blood sugar measurement, by about only 1%. The drug also caused weight loss of a mean of 5 to 6 pounds in users.
ISMP Data from 2015 Quarters 1 & 2
According to the ISMP QuarterWatch (PDF) issued Jan. 13, 2016, both prescriptions and adverse event reports are increasing for SGLT2 inhibitor diabetes drugs. The increased prescription rates come despite repeated warnings from the FDA and ISMP, as well as a lack of long-term data on the potential health risks posed by the medications.
“Despite the lack of long-term data on safety and benefits, these new drugs have moved rapidly into widespread clinical use, according to data from IMS Health,” the ISMP report states. “We observed increasing numbers of reports of metabolic acidosis – a potentially life-threatening disorder that has been the focus of two FDA Drug Safety Communications.”
Other findings from the report:
- By the second half of 2015, there were 1.1 million prescriptions for Invokana, 411,000 for Farxia, and 136,000 for Jardiance.
- Over the past year, there were at least 168 adverse event reports submitted to the FDA involving ‘metabolic acidosis’ linked to Invokana, 80 associated with Farxiga, and 12 with Jardiance.
- The most commonly reported side effect of SGLT2 inhibitors was genital fungal infections, which in clinical trials affected 11.4% of women treated with Invokana, and 3.7% of men.
FDA Strengthens Invokana Bone Fracture Warning
The FDA has strengthened warnings for the type 2 diabetes medication canagliflozin (Invokana, Invokamet) related to an increased risk of bone fractures, according to a drug safety communication issued September 10. To address these concerns, the agency has added a new “Warning and Precautions” section and revised the “Adverse Reactions” section of the Invokana and Invokamet drug labels. Click here to learn more.
Before Taking Invokana
Before taking Invokana, be sure to tell your doctor if any of the following factors apply to you, as they increase your likelihood of having medical problems:
- Kidney disease
- Liver disease
- Heart disease
- High blood pressure
- Low blood pressure
- An electrolyte imbalance
- High cholesterol
- If you are on a low-salt diet
- If you take insulin or another diabetes drug
- It is unknown whether Invokana can harm a fetus or an infant being breastfed, so make sure to talk to your doctor if you are pregnant or plan on becoming pregnant
SGLT2 Inhibitor Drugs Linked to Flesh-Eating Genital Infections
August 29, 2018 – FDA is warning that type-2 diabetes drugs from the SGLT2 inhibitor class have recently been linked to a gruesome genital infection called necrotizing fasciitis of the perineum, also known as Fournier’s gangrene. The condition has been conclusively diagnosed in at least a dozen patients, all of whom required hospitalization and surgery, including one who died from complications resulting from the condition.
Two New Invokana Amputation Lawsuits Filed in New Jersey
January 4, 2018 – Two recent lawsuits filed in New Jersey State Court have brought renewed attention to the amputation risk associated with Janssen’s type 2 diabetes medicine Invokana.
Both plaintiffs in the new cases were forced to have a foot and leg amputated below the knee after less than 1 year after beginning treatment with Invokana. Meanwhile, many physicians have weaned their diabetic patients off the drug while others have used a “wait and see” approach.
One of the plaintiffs is a 60-year-old man who started using Invokana in January 2017. Within 12 months, the man lost his left foot and right leg below the knee, according to the lawsuit. The other complaint was filed by a 53-year-old man who was required to undergo a below-knee amputation of his right leg in December 2015 after beginning a regimen of the drug in April 2015.
Both plaintiffs have since discontinued treatment with Invokana in favor of diabetes medicines with fewer side effects, according to the lawsuits. The complaints allege that Johnson & Johnson subsidiary Janssen Pharmaceuticals knew that Invokana could increase the risk of amputation, yet chose to keep this information secret in an effort to maximize profits.
Study Links Invokana to Doubled Risk of Amputation
October 1, 2019 – Diabetes patients who take Invokana had a doubled risk for amputations of the toes or feet compared to patients who took a placebo, according to a new study.
Data presented last month at the annual meeting of the American Diabetes Association (ADA) indicated that Invokana can significantly reduce the risk of severe heart problems in diabetes patients with established or elevated risk for heart disease.
Invokana was also found to the reduce risk of hospitalization for heart failure and protect against kidney function decline. Unfortunately, use of the drug was also associated with a doubled risk for lower limb amputations. The combined studies included a cohort of 10,142 type 2 diabetes patients.
The research was conducted to demonstrate that Invokana does not cause heart complications. Results showed that it reduced the combined risk of non-fatal heart attack, heart-related death, and non-fatal stroke by 14% compared to a placebo.
For every 3 strokes, heart attacks, or cardiovascular deaths prevented by Invokana, though, there were 2 amputations, 71% of which were of toes or the lower foot.
The risk for amputations with Invokana boosted sales of Jardiance (generic: empagliflozin), a competing diabetes drug that had already shown effective at reducing risk of cardiovascular death without the risk of amputation. In a study published in New England Journal of Medicine (NEJM) in September 2015, investigators reported that Jardiance reduced the risk for heart attack, strokes, and cardiovascular deaths by 14%, which is the same with Invokana.
FDA Requires Boxed Warning on Amputation Risk with Invokana
May 16, 2017 – The FDA has concluded that patients who take Invokana and Invokamet for the treatment of type 2 diabetes face an increased risk of leg and foot amputations.
Based on data from 2 large clinical trials — the CANVAS and CANVAS-R studies — FDA is requiring that labels of Invokana and Invokamet be updated with a boxed warning about an increased risk of amputations associated with use of the drugs.
Final results from CANVAS and CANVAS-R indicated that patients treated with canagliflozin were about twice as likely to have a foot or leg amputation compared to those who received a placebo. Specifically, CANVAS found that over a year’s time, the amputation risk was equivalent to:
- 5.9 out of every 1,000 patients treated with canagliflozin
- 2.8 out of every 1,000 patients treated with placebo
Over the same time period, CANVAS-R found the risk to be:
- 7.5 out of every 1,000 patients treated with canagliflozin
- 4.2 out of every 1,000 patients treated with placebo
Invokana Kidney Failure Lawsuit Filed in New Jersey
May 1, 2017 – A woman from New Jersey has filed a lawsuit against Johnson & Johnson and its Janssen subsidiary for failing to warn about the risk of kidney failure from Invokana.
According to the lawsuit (PDF), Plaintiff Jessica Calongne developed an acute kidney injury less than a month after starting treatment with Invokana, which eventually led to kidney failure (end-stage renal disease or “ERSD”).
Calongne alleges that she was prescribed Invokana for the treatment of diabetes in April 2015, and developed ERSD by the end of the next month. She claims J&J misrepresented that Invokana is a safe and effective treatment for diabetes when in fact the medicine can lead to adverse health consequences which require hospitalization, including diabetic ketoacidosis (DKA) and kidney failure.
Calongne alleges that her injuries were preventable and the result of J&J’s failure to adequately test Invokana and warn the public and medical community about its potential health risks. Plaintiff also claims the manufacturers withheld information in an effort to maximize profits. Calongne’s lawsuit will be consolidated as part of multidistrict litigation No. 2750.
Indiana Woman Alleges Ketosis from Invokana
April 6, 2017 – A woman from Indiana who claims that side effects of Invokana caused her to develop severe dehydration and profound ketosis has filed a products liability lawsuit in the U.S. District Court for the District of New Jersey. Plaintiff Teresa Ross was prescribed Invokana in 2013 for the treatment of type 2 diabetes, and developed starvation ketosis and dehydration in May 2015 as a result of her use of the drug, according to the lawsuit.
Court Establishes ‘Benefit and Expenses Fund’ for Invokana MDL
March 30, 2017 – A Common Benefit Fee and Expense Fund has been established in the Invokana MDL “to provide for the fair and equitable sharing among plaintiffs and their counsel” for expenses incurred during the litigation process. The funds apply to all Invokana and Invokamet lawsuits pending in MDL No. 2750, according to a Pretrial Order issued last week.
Plaintiffs Fight to Stop Transfer of Invokana Lawsuits to New Jersey
January 12, 2017 – More than 100 plaintiffs with lawsuits alleging kidney damage from Invokana are challenging Janssen’s attempt to transfer the cases to the multidistrict litigation (MDL) in New Jersey. Janssen recently filed a motion seeking to stay and then transfer or dismiss 106 Invokana lawsuits that were originally filed in Pennsylvania state court. Plaintiffs responded to the motion Monday, arguing that the transfer would go against “virtually all of” the factors courts should consider when trying the cases.
Invokana Lawsuits Consolidated in New Jersey
December 19, 2016 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits alleging kidney failure and diabetic ketoacidosis from Invokana and Invokamet will be transferred to the District of New Jersey for pretrial handling before Judge Brian R. Martinotti. J&J and Janssen currently face about 55 such complaints in courts across the U.S. However, it is expected that this number will grow into the hundreds or even thousands by the time the litigation process is complete.
Janssen Wants Invokana Lawsuits Transferred to New Jersey
December 1, 2016 – Janssen Pharmaceuticals is seeking to move over 100 Invokana lawsuits from the Philadelphia Court of Common Pleas to federal court in New Jersey. Plaintiffs’ counsel proposed that the cases be consolidated and tried together as part of a mass tort proceeding in state court; however, Janssen has pointed to the Class Action Fairness Act (CAFA) as the basis for removal to federal court.
Plaintiffs’ Lawyers Request MDL for Invokana Litigation
September 30, 2016 – Two plaintiffs filing Invokana lawsuits have requested that a multidistrict litigation (MDL) be established to consolidate the cases into a single jurisdiction for pretrial handling. Earlier this month, a plaintiff from New York filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federal Invokana lawsuits in the U.S. District Court of New Jersey. A similar request has also been made by plaintiffs in Philadelphia, suggesting a mass tort program.
FDA Strengthens Kidney Injury Warning on Invokana
June 14, 2016 – The Food & Drug Administration today upgraded existing warnings about the risk of acute kidney injury with SGLT2 inhibitors (Invokana, Invokamet, Farxiga, Xigduo XR). From March 2013 to October 2015, the agency received at least 101 confirmable reports of the condition — some requiring emergency hospitalization and dialysis treatment — associated with the drugs.
Invokana Elevates Risk of Ketoacidosis-Related Events in Type 1 Diabetics, Study Finds
June 13, 2016 – In a Phase II study of type 2 diabetes patients, Invokana administered with insulin was superior to a placebo-insulin combo at both lowering mean glucose levels and glycemic variability, according to FiercePharma. However, the drug also increased the rate of serious adverse events related to diabetic ketoacidosis. Still, Janssen is continuing to explore the potential for Invokana as a treatment for type 1 diabetes, in part because “there have not been a great number of targets for intervening in the disease,” according to Jim List, Janssen’s global head of cardiovascular and metabolism.
FDA Issues Invokana Amputation Warning
May 18, 2016 – The interim safety results from an ongoing clinical trial found an increase in leg and foot amputations — mostly affecting the toes — associated with canagliflozin, the active ingredient in Invokana, according to an FDA Drug Safety Communication issued today. Healthcare professionals have been advised to follow the recommendations in canagliflozin drug labels and to monitor patients for “any new pain or tenderness, sores or ulcers, or infections in their legs or feet,” the agency said.
Janssen Seeks to Push Invokana Lawsuits Out of Philadelphia
May 16, 2016 – Janssen has filed a forum non conveniens motion seeking to have the case Jeffries v. Janssen Pharmaceuticals transferred from the Philadelphia Court of Common Pleas to Tennessee, the plaintiff’s home state. This is the first such motion to be filed over Invokana in Philly, but Janssen is reviewing “all other cases filed in Philadelphia and will file such motions when similar out-of-state facts exist,” according to company spokeswoman Kaitlin Meiser.
Invokana Lawsuit Filed in New Jersey
April 25, 2016 – A Texas woman who allegedly suffered kidney damage and ketoacidosis after taking Invokana has filed a product liability lawsuit (PDF) against Janssen Pharmaceuticals in the U.S. District Court of New Jersey Trenton Division. According to the complaint, the woman only took the medication for about a month before developing both conditions. Plaintiff’s husband is claiming loss of consortium in the case.
Invokana Linked to Ketone-Related Events in Type 1 Diabetics, Study Finds
April 14, 2016 – Ketone-related adverse events occurred in 5-10% of type 1 diabetes patients who took 100 mg or 300 mg doses of Invokana in addition to insulin, according to a study published in Diabetes Care. The researchers looked at 351 patients with type 1 diabetes who were randomly assigned to take Invokana or a placebo once daily before breakfast. After 18 weeks, 5.1% of patients on the 100 mg dose and 9.4% of patients on the 300 mg dose had suffered a ketone-related adverse event. Additionally, injuries requiring hospitalization occurred in 4.3% of patients on the 100 mg dose and 6% on the 300 mg dose.
California Woman Seeks Punitive Damages Against Janssen
March 31, 2016 – A California woman who allegedly developed acute kidney injury and acute kidney failure after taking Invokana has filed a product liability lawsuit against Janssen Pharmaceuticals. Plaintiff alleges that although Invokana warning labels mention the kidneys, they only state that a “possible side effect” is “kidney problems.” This warning doesn’t adequately convey the dangers or address the actual risk of kidney failure, according to the complaint.
Invokana Linked to Increased Heart Attack, Stroke Risk During First 30 Days of Treatment
March 25, 2016 – During post-marketing clinical trials, several type 2 diabetes patients treated with Invokana had strokes or heart attacks. After the 30-day period passed, the risk factors suddenly and inexplicably leveled out. The researchers were unable to determine exactly why this occurred, although it is has been well documented that diabetes drugs can increase cholesterol levels, leading to heart problems.
Texas Woman Claims Invokana Caused DKA, Kidney Damage
March 16, 2016 – Another product liability lawsuit has been filed against Janssen Pharmaceuticals by a Texas woman who allegedly suffered diabetic ketoacidosis and kidney damage after taking Invokana. According to the complaint, the woman started taking Invokana in Oct. 2013, and soon thereafter was diagnosed with both conditions. The suit was filed in New Jersey; plaintiff is seeking $10 million in damages from Janssen.
Louisiana Man Claims He Suffered DKA, Kidney Damage from Invokana
March 2, 2016 – Charles Maddox, who alleges he developed kidney damage and diabetic ketoacidosis after taking Invokana for less than 7 months, has filed a product liability lawsuit against Janssen Pharmaceuticals. The complaint accuses Janssen of failing to warn of the “unreasonably dangerous risks” associated with Invokana, and seeks both compensatory and punitive damages for breach of warranty, manufacturing a defective drug, negligence and fraudulent misrepresentation. The case is: Charles Maddox v. Janssen Pharmaceuticals Inc. et al, case No. 2:2016-cv-01189 at US District Court for the Eastern District of Louisiana.
Alabama Woman Alleges Diabetic Ketoacidosis from Invokana
February 11, 2016 – A woman from Alabama who was allegedly diagnosed with ketoacidosis just 3 months after beginning treatment with Invokana has filed a product liability lawsuit (PDF) against Janssen Pharmaceuticals. Plaintiff claims she was unaware of the risk of DKA from Invokana, and accuses Janssen of negligence for failure to adequately warn or properly study the drug.
Tennessee Man Says Kidney Failure Caused by Invokana
February 9, 2016 – A man from Tennessee who claims he got kidney failure after taking Invokana has filed a product liability lawsuit against the manufacturers. Plaintiff alleges he relied on claims made by the defendants that Invokana was safe for the treatment of type 2 diabetes, and blames his injuries on the companies’ failure to warn about the potential health risks associated with the drug. The complaint was filed Dec. 14, 2015, in the U.S. District Court for the Western District of Tennessee.
Has There Been a Recall?
To date, Invokana has not been recalled in the U.S. or any other country. However, the drug has only been on the market a short time (Invokana was approved in March 2013) and the investigation into its potential health risks is still in its early stages. It often takes many years and countless hours of attorney time before all the facts leading to a recall emerge.
Invokana Settlement Information
Invokana settlements have not yet been paid to victims and the litigation is still ongoing. As more complaints continue to be filed, the expected settlement amounts will continue to increase.
If you’ve been injured by Invokana, there is still time to file a suit. However, it is important that you act now in order to protect your legal rights – Invokana lawsuits are bound by state-imposed statutes of limitations (SOL), which means there is a limited amount of time in which to file your claim.
Is There a Class Action?
No class action has yet been filed in the Invokana litigation. Instead, our lawyers are handling individual lawsuits for people who have been injured by the drug. At some point, the complaints may be consolidated into a multidistrict litigation (MDL) for pretrial discovery and investigation, as well as a possible settlement. In an MDL, each complaint is separate, and clients are not required to settle their case as part of a class action group. Each client gets to make their own decision as to whether to take their case to trial or not.
Some of the claims made in Invokana lawsuits accuse the manufacturers of:
- Failure to warn of risks
- Manufacturing a defective drug
- Misrepresenting the dug’s risks and benefits
Because there is a time limit to file your claim, it is important that you seek professional legal advice quickly if you feel you were injured by Invokana. For more information about this drug, its dangers, side effects and potential health risks, please visit our Invokana FAQ page.
Do I Have an Invokana Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new ketoacidosis cases in all 50 states.
Again, if you or a loved one was injured by the side effects of Invokana, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.