What is Invokana?
Invokana (generic: canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor drug used to control blood sugar in patients with type 2 diabetes, a disease that affects nearly 30 million Americans — almost 10% of the U.S. population — each year. The medicine 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 U.S. Food & Drug Administration (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”). From March 2013 to June 6, 2014, at least 20 cases of ketoacidosis in patients who used these diabetes medications were reported to the FDA’s Adverse Events Reporting System (FAERS).
Diabetic ketoacidosis does not usually occur in patients with type 2 diabetes, 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 urinary tract infections (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
Source: Mayo Clinic
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, ketoacidosis was diagnosed by a healthcare professional, and hospitalization was required to treat the problem. A link between DKA 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
How Can Invokana Cause Kidney Damage?
Invokana increases levels of creatinine, a breakdown product of creatine phosphate in muscle tissues that is usually excreted in the urine through the kidneys. Therefore, Invokana users are more likely to have their kidneys return creatinine to the bloodstream, which, at increased levels, can cause impaired kidney function.
FDA is aware of dozens of cases of life-threatening kidney infections associated with Invokana. Many of these Invokana side effects started as urinary tract infections which progressed into kidney or blood infections. All patients with kidney infections from Invokana required hospitalization, and several required more serious treatment such as dialysis or a kidney transplant, according to the FDA.
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 was issued on the heels of a quarterly report by the Institute for Safe Medication Practices (ISMP) which 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)
- Urinary tract infections (50 cases)
- Dehydration / fluid imbalance (54 cases)
- Kidney stones (11 cases)
- Abnormal weight loss (52 cases)
Janssen told ISMP investigators that most of the injuries are known risks that are warned about on the labeling and/or prescribing information of Invokana; however, the agency’s report questions whether the benefits provided by the drug justify the risks. According to the ISMP, pre-approval clinical trials indicated that Invokana lowered levels of glycated hemoglobin (HbA1c), a primary type 2 diabetes blood sugar measurement, by about only 1%. The drug also caused weight loss (5 to 6 pounds) in most users.
ISMP Data from 2015 Quarters 1 & 2
According to the ISMP QuarterWatch 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 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 Farxiga, 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 and 3.7% of men.
FDA Strengthens Invokana Bone Fracture Warning
The FDA has strengthened warnings for the type 2 diabetes medication canagliflozin — the active ingredient in Invokana and Invokamet — related to an increased risk for 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 labeling.
Before Taking Invokana
Before taking Invokana, be sure to tell your doctor if any of the following risk factors apply to you, as they increase your likelihood of complications:
- 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
Study Links Invokana to Doubled Risk of Amputation
October 1, 2019 – Diabetes patients who took Invokana had a doubled risk for amputations of the toes or feet compared to patients who took a placebo, according to a recent study.
Data presented at the 2019 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, a competing diabetes drug that had proved 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.
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 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 Invokana.
Both plaintiffs 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 was 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 Janssen Pharmaceuticals knew that Invokana could increase the risk of amputation, yet chose to keep this information secret in an effort to maximize profits.
FDA Requires ‘Black Box Warning’ on Amputation Risk with Invokana
May 16, 2017 – 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 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 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 she had a stroke after taking Invokana has filed a products liability lawsuit against Janssen Pharmaceuticals and Johnson & Johnson.
According to the lawsuit, Plaintiff used Invokana to treat her type 2 diabetes from February 2015 through June 2015. She claims she took the drug as prescribed, and believed the claims made by the defendants that it was safe to use as directed.
However, after beginning treatment, plaintiff alleges that she had a stroke. She claims that Janssen and J&J failed to warn about the risk of stroke, and that she was unaware the drug could cause such a condition. She adds that had she known, she would have opted to take a diabetes drug with fewer potential side effects.
The case joins a growing number of Invokana lawsuits filed in courts across the U.S., most of which are alleging diabetic ketoacidosis and kidney failure injuries from the drug.
Plaintiff in the new case brings counts of manufacturing defect, defective design, failure to warn, breach of warranties, negligence, fraudulent and negligent misrepresentation, fraudulent concealment, and fraud.
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 multidistrict litigation (MDL No. 2750) “to provide for the fair and equitable sharing among plaintiffs and their counsel” for expenses incurred during the litigation process.
According to a Pretrial Order (PDF) issued March 21, 2017, the funds apply to all Invokana and Invokamet lawsuits pending in MDL No. 2750.
“Common benefit work product includes all work performed for the benefit of all plaintiffs, including pre-trial matters, discovery, trial preparation, a potential settlement process, and all other work that advances this litigation to conclusion,” the Order states.
Last December, a panel of judges ordered that all Invokana and Invokamet lawsuits filed on the federal level would be transferred to the District of New Jersey as part of an MDL to be overseen by Judge Brian R. Martinotti. At the time of the filing, the litigation included about 55 lawsuits alleging the medications may cause serious injury, and that Janssen failed to adequately warn about these risks. The cases have enough similarity to consolidate, according to the JPML.
“The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage,” the Transfer Order states. “The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.”
Invokana Lawsuits Consolidated in New Jersey
December 19, 2016 – A panel of judges has ordered that all federal lawsuits alleging ketoacidosis and kidney failure from the diabetes medications Invokana and Invokamet will be transferred to the District of New Jersey before Judge Brian R. Martinotti.
Johnson & Johnson and its subsidiary Janssen Pharmaceuticals currently face about 55 Invokana lawsuits in federal courts across the U.S. The complaints allege that the companies failed to adequately warn about the risk of Invokana side effects, which include diabetic ketoacidosis, kidney failure, heart attack, stroke and more.
The multidistrict litigation will only include lawsuits regarding Invokana and Invokamet. Similar claims have been alleged against other diabetes medications from the sodium glucose co-transporter 2 (SALT-2) inhibitor class. JPML determined that the litigation will not include claims stemming from the 4 other drugs because there was a risk of complicating case management in the litigation. The 4 other drugs are not made by Janssen or J&J.
“Centralizing competing defendants in the same MDL may unnecessarily complicate case management, due to the need to protect trade secret and confidential information,” the transfer order stated. “In addition, a multi-defendant MDL may prolong pretrial proceedings, because of, inter alia, the possible need for separate discovery and motion tracks, as well as the need for additional bellwether trials.”
FDA Strengthens Kidney Injury Warning on Invokana
June 14, 2016 – The Food & Drug Administration has 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.
Invokana Lawsuit Filed in Illinois
April 29, 2016 – An Illinois man who allegedly suffered kidney damage after taking Invokana has filed a products liability lawsuit against Janssen Pharmaceuticals.
According to the lawsuit, plaintiff began taking Invokana to treat his type 2 diabetes in September 2013, and shortly thereafter developed severe kidney injuries which resulted in physical and emotional damages including “pain and suffering, emotional distress, loss of enjoyment of life, and economic loss including significant expenses for medical care and treatment which will continue in the future.”
Plaintiff is accusing Janssen of actively concealing information about the side effects of Invokana. The lawsuit was filed in U.S. District Court for the Southern District of Illinois under case number 3:15-cv-1180 (PDF). Plaintiff is seeking compensatory and punitive damage in excess of $75,000.
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 – As the number of lawsuits filed in Philadelphia over Invokana continues to grow, Janssen has begun looking to send the complaints elsewhere.
The drugmaker filed a forum non conveniens motion last week 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.
“Plaintiff’s decision to file suit in Philadelphia County is part of a trend where plaintiffs who have no connection to Pennsylvania demand that the taxpayers and courts of Philadelphia County hear their claims,” Meiser said. “In this case, we are asking the court to dismiss the claims of the plaintiff who never lived in Pennsylvania and does not claim her alleged injuries occurred in the state.”
This year has seen numerous Invokana lawsuits filed in the Philadelphia Court of Common Pleas. Last month alone at least 15 such cases were filed, and court records indicate at least 33 pending cases on the books there.
Although the plaintiffs have not yet sought to consolidate the lawsuits into a mass tort, a request has been made to informally coordinate case management and other status conferences for complaints related to Invokana.
The litigation has thus far centered on allegations that Invokana causes kidney failure and diabetic ketoacidosis (DKA). Jeffries claims in her lawsuit that she developed both conditions as well as a stroke from using Invokana.
The forum non conveniens motion argues that Jeffries’ complaint should be moved to Tennessee because she allegedly used the drug, was injured and underwent medical care in that state. Additionally, the motion contends that the lawsuit has no connection with Pennsylvania, as none of the research and development, marketing or decision making that led to the development of Invokana are based in Pennsylvania.
Invokana Lawsuit Filed in New Jersey
April 25, 2016 – A Texas woman who allegedly developed ketoacidosis and kidney damage after taking the type 2 diabetes medication Invokana (generic: canagliflozin) has filed a product liability lawsuit against Janssen Pharmaceuticals in U.S. District Court for the District of New Jersey, Trenton Division.
According to the lawsuit (case number 3:15-cv-08070-AET-LHG), Plaintiff Maria Puente began taking Invokana in October 2013 and was shortly thereafter diagnosed with both diabetic ketoacidosis and kidney damage. Her husband Carlos is claiming loss of consortium in the case.
The suit alleges Maria’s injuries were “preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”
As a result of these actions, Maria suffered a number of adverse health consequences including:
- the requirement of continued healthcare services
- medical and related expenses
- diminished capacity for the enjoyment of life
- diminished quality of life
- increased risk of premature death
- aggravation of preexisting conditions
- activation of latent conditions
- other losses and damages
Invokana Linked to Ketone-Related Events in Type 1 Diabetics, Study Finds
April 14, 2016 – Following a recent warning by the FDA which suggested that type 2 diabetics who take Invokana may face an increased risk of acid buildup in their blood, a new study has identified a similar risk in patients with type 1 diabetes.
For the study, a research team led by Anne L. Peters, MD, of the Keck School of Medicine at the University of Southern California looked at data from 351 type 1 diabetes patients with baseline HbA1c 7% to 9%. Test subjects were on a stable insulin regimen of multiple daily insulin injections or continuous subcutaneous insulin infusion for a minimum of 8 weeks prior to screening.
Participants were randomly assigned to take Invokana 100 mg (n = 117) or 300 mg (n = 117) or a placebo once daily before their 1st meal of the day. The researchers aimed to determine the effect of Invokana as an add-on to insulin on glycemic control and weight, as well as the incidence of severe adverse events including diabetic ketoacidosis.
At week 18, the incidence of ketone-related events was 5.1% among those treated with Invokana 100 mg, 9.4% with the 300 mg dosage, and none in the placebo group. Most adverse events occurred after patients had taken the drugs for at least 1 month.
DKA injuries requiring hospitalization occurred in 4.3% of the Invokana 100 mg group and 6% of the 300 mg group. Of the 12 participants who developed ketoacidosis, the range of blood glucose levels at the time of hospitalization was 9.4 mmol/L to over 44.4 mmol/L; 5 participants had blood glucose concentrations.
Patients who took the 100 mg dose of Invokana had a median time of 116 days to a serious ketosis event compared to a median of 32 days with the 300 mg dose. Coexisting factors were present in all test subjects who suffered an adverse event including:
- Infusion-site infection
- Food poisoning
- Insulin pump failure/malfunction
- Non-compliance with insulin regimen
- Decreased food intake.
There was no difference in baseline characteristics between patients who suffered a ketone-related injury compared to those who were not injured that would appear to predict additional risk, the researchers found.
“People with type 1 diabetes who use an SGLT-2 inhibitor are at increased risk for DKA, which appears to be dose related,” Peters said. “If [canagliflozin is] used in this off-label fashion, patients should be fully educated as to this risk and willing to monitor ketones at times of illness or other stress, and only the lowest dose of the SGLT-2 inhibitor should be used.”
California Woman Seeks Punitive Damages Against Janssen
March 31, 2016 – A California woman who allegedly developed kidney failure after taking Invokana has filed a product liability lawsuit seeking punitive damages from drugmaker Janssen Pharmaceuticals.
According to the complaint, which was filed in the U.S. District Court for the Central District of California, plaintiff was prescribed Invokana to treat the symptoms of type 2 diabetes. The woman claims that after taking the medication as directed, she was hospitalized in April 2015 and then again in May 2015 for acute kidney injury and acute kidney failure, respectively. Had Janssen adequately warned about the risk of these conditions, plaintiff alleges she would have never taken Invokana, as there are safer alternatives available.
Plaintiff further alleges that although the Invokana label mentions the kidneys, it does so in a very general manner, stating 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 lawsuit.
Like others who have filed complaints against Janssen, plaintiff in this case blames the company for failing to adequately research Invokana to determine its safety, and for aggressively promoting the drug as a safe treatment for diabetes while simultaneously downplaying its risks.
She further alleges that Invokana is significantly more dangerous than the ordinary consumer would expect, and that Janssen knew or should have known that the drug’s warning label was incorrect and misleading. Plaintiff asserts counts of strict liability, design defect, failure to warn, negligence, breach of warranties, fraud, misrepresentation, fraudulent concealment, negligent misrepresentation and violation of the Fair Business Practices Act of 1975, and seeks both compensatory and punitive damages in excess of $75,000.
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 Kidney Damage, DKA
March 16, 2016 – Another product liability lawsuit has been filed against Janssen Pharmaceuticals over injuries allegedly caused by Invokana. The new lawsuit was filed by a Texas woman who claims Janssen is responsible for her development of ketoacidosis after taking Invokana. Her complaint was filed in New Jersey; she is seeking $10 million in damages from the drugmaker.
According to the suit, plaintiff started taking Invokana to treat the symptoms of her type 2 diabetes in Oct. 2013. She claims that shortly after beginning treatment, she suddenly began developing severe injuries including diabetic ketoacidosis and kidney damage. As a result of these problems, the woman stopped taking Invokana in Nov. 2013.
Ketoacidosis occurs when a person’s blood contains too much toxic acid or ketones. Kidney damage has also commonly been linked to Invokana through adverse events reported to the FDA. The agency recently issued a public safety communication regarding the link between SGLT2 inhibitor diabetes drugs like Invokana and ketoacidosis, which can lead to diabetic coma (passing out for long periods of time or even death if left untreated).
Louisiana Man Alleges Ketoacidosis, Kidney Damage from Invokana
March 2, 2016 – A man who claims he suffered both kidney damage and diabetic ketoacidosis after taking Invokana has filed a product liability lawsuit against Janssen.
According to the complaint, which was filed last month in the U.S. District Court for the Eastern District of Louisiana, Janssen failed to disclose “unreasonably dangerous risks” associated with Invokana, and that this caused plaintiff Charles Maddox significant damages.
Maddox claims he began taking Invokana to treat diabetes in July 2014, and was diagnosed with kidney damage and diabetic ketoacidosis in February 2015. He claims that Janssen knew of these potential health risks, yet willfully failed to warn the public and medical community about of them.
“The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit states. “This conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
Maddox is suing Janssen for breach of warranty, manufacturing a defective drug, negligence and fraudulent misrepresentation. Plaintiff is seeking both compensatory and punitive damages as a result of his injuries. 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 – An Alabama woman who allegedly developed diabetic ketoacidosis after taking Invokana has filed a product liability lawsuit against Janssen Pharmaceuticals.
According to allegations raised in the complaint, plaintiff began taking Invokana in December 2014, and shortly thereafter developed diabetic ketoacidosis. 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. She also claims the company was negligent for marketing Invokana ‘off-label’ to treat type 1 diabetes and lower blood pressure. The complaint was filed in the Southern District of Alabama under case number 1:15-cv-00636.
Ketoacidosis is a dangerous, potentially fatal medical condition that occurs when there isn’t enough insulin in the body. FDA has warned diabetes patients who use SGLT2 inhibitor drugs like Invokana to be aware of the symptoms of ketoacidosis, which include thirst, frequent urination, nausea, abdominal pain, weakness, fruity-scented breath and confusion.
The Alabama lawsuit is similar to another complaint (case #15-12-00653) recently filed in the Philadelphia Court of Common Pleas by a man who claims he was diagnosed with diabetic ketoacidosis just 3 months after beginning treatment with Invokana.
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 is 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, 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.
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 Pharmaceutical 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 injury and death cases in all 50 states.
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 suit and we can help.