Most type 2 diabetes patients already live at risk of amputation. Most common are amputations of the lower leg, foot or toe, as blood flow to the extremities slows to a perilous rate. Now, federal officials say that Invokana increases the risk even higher. In fact, the FDA’s most recent announcement goes out of its way to make clear that canagliflozin, the drug’s active ingredient, “causes” an increase in the risk for leg and foot amputations, especially toe amputations and procedures involving the middle of the foot. Most FDA warnings aren’t that strong.
Studies Show Causal Link
The agency’s decision comes after the results of two major studies, CANVAS and CANVAS-R, were finally published. In both research projects, clinical trial reviewers observed a near doubling in the risk of leg and foot amputations. In a single year, patients taking Invokana for the CANVAS trial required amputations at a rate of 5.9 in 1,000. The risk for patients taking a placebo was half that, at 2.8 in 1,000. CANVAS-R showed comparable numbers. 7.5 out of every 1,000 Invokana patients in the trial underwent amputation procedures. Only 4.2 in 1,000 placebo patients did.
While hundreds of injured patients have already filed Invokana lawsuits, most of these pending claims involve other severe side effects, from diabetic ketoacidosis to kidney failure. But with the results of these newly-published clinical trials, legal experts believe that patients who underwent amputation procedures while taking Invokana may also be eligible to file suit.
If you or a loved one took Invokana for your Type II Diabetes and suffered a foot or leg amputation as a result of taking the drug, do not hesitate to contact our experienced product liability attorneys for a free case evaluation. You may be entitled to substantial financial compensation.
Label Changes To Reflect Ketoacidosis Risk
Reviewing adverse event reports filed between 2013 and 2014, the FDA identified 20 patients in whom Invokana was linked to a form of elevated blood acidity; all required emergency medical intervention.
As a result, the FDA cautioned patients taking Invokana and other SGLT2 inhibitors to monitor for difficulty breathing, nausea and vomiting, excessive fatigue, abdominal pain and disorientation, all early warning signs of ketoacidosis.
What Is Diabetic Ketoacidosis?
The agency continued to monitor incoming reports, eventually identifying 73 cases of ketoacidosis from 2013 to 2015 – all of which required hospitalization. For the FDA, those warning signs were clear enough to warrant a label change. As of December 4, 2015, Invokana’s label reads:
“Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance with type 1 and type 2 diabetes mellitus receiving […] SGLT2 inhibitors, including Invokana […] Patients treated with Invokana who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels […] If ketoacidosis is suspected, Invokana should be discontinued.”
That warning may be enough to save future patients, but critics say it’s come too late for many people.
Patients Are Now Filing Lawsuits
Consumer advocate groups, including the Institute for Safe Medication Practices, have been warning about Invokana’s link to ketoacidosis for more than a year. As we’ve seen, the FDA publicly announced the possibility in May of 2015. The drug’s manufacturer, however, did nothing, according to plaintiffs in a series of new Invokana lawsuits. Rather than warn the public, Janssen Pharmaceuticals, a subsidiary of corporate giant Johnson & Johnson, actively defended its product, patients claim.
The FDA’s ketoacidosis labeling revision came on December 4, 2015, and only 6 days would pass before the first Invokana lawsuit was filed. Brought by Arthur Portnoff, a former Invokana patient, the lawsuit claims Janssen Pharmaceuticals was well-aware of the drug’s serious risks, but failed to warn doctors. Shockingly, Portnoff says he began taking Invokana in November of 2014 and was diagnosed with diabetic ketoacidosis only three months later. His lawsuit, filed in the Philadelphia Court of Common Pleas, was registered under the case number 15-12-00653.
In Alabama, Woman Calls Invokana “Defective, Dangerous”
On December 8, 2015, Luana Jean Collie added her own voice to what legal experts believe will become a major litigation. Collie, a resident of Orange Beach, Alabama, says she began taking Invokana in December 2014, believing the drug a “safe and effective” choice to treat her type 2 diabetes. But only months later, she was suffering the severe consequences of ketoacidosis.
Shocked to learn that numerous red flags were seemingly ignored by the drug’s manufacturer, Collie took action, filing a lawsuit in the US District Court for the Southern District of Alabama. She accuses Janssen of failing “to properly assess and publicize alarming safety signals” and suppressing “information revealing serious and life-threatening risks.”
Portnoff and Collie will not be alone in their calls for justice. In the first three months of 2015 alone, Invokana sales raked in $278 million for Janssen Pharmaceuticals. The drug has proved a blockbuster, among health care professionals and alike, many of whom are still unaware of its substantial risks. As public awareness grows, and more patients come forward, the legal community expects numerous Invokana lawsuits to be filed in the coming months.
Can I File An Invokana Lawsuit?
Any patient who was prescribed Invokana and then suffered from ketoacidosis or underwent an amputation may be eligible to file a personal injury lawsuit against the drug’s manufacturer. Attorneys are also investigating claims that Invokana may be linked to kidney failure, cardiovascular complications, and bone fractures.
In a lawsuit, harmed patients may be able to claim damages for:
- past and future medical expenses,
- lost wages,
- a diminished capacity to work,
- emotional anguish and
- pain and suffering.
Banville Law’s experienced dangerous drug attorneys are currently providing free consultations to patients who believe they may have a potential Invokana claim. Case evaluations come at no charge and no obligation.
New Type 2 Diabetes Drug Linked To Severe Health Complications
Approved on March 29, 2013, Invokana is one of several “new generation” type 2 diabetes drugs known as “SGLT2 inhibitors.” All drugs within this class have been found to increase the risk of ketoacidosis:
- Invokana (active ingredient: canagliflozin), manufactured by Janssen Pharmaceutical, a subsidiary of Johnson & Johnson
- Invokamet (active ingredients: canagliflozin and metformin), manufactured by Janssen Pharmaceutical
- Jardiance (active ingredient: jardiance), manufactured by Eli Lilly and Boehringer-Ingelheim
- Glyxambi (active ingredients: empagliflozin and linagliptin), is also made by Lilly and Boehringer
- Farxiga (active ingredient: dapagliflozin), manufactured by AstraZeneca
- Xigduo XR (active ingredients: dapagliflozin and metformin), manufactured by AstraZeneca
What Are SGLT2 Inhibitors?
SGLT2 inhibitors (or “sodium-glucose cotransporter-2 inhibitors”) block the kidney’s natural ability to filter blood glucose from urine. Rather than returning the body’s main energy source to the blood stream, Invokana forces glucose to be excreted. In light of the drug’s mechanism of action, health experts have said that the newly-identified dangers could have been “reasonably expected.”
The drug is approved only for use in patients with type 2 diabetes, who suffer from “insulin resistance.” In these patients, the body’s cells are unable to convert glucose into energy, leading to dangerously high blood sugar levels and long-term organ degeneration. And while Invokana may increase the body’s ability to dispose of excess glucose, the drug seems to increase blood acids, or “ketones,” as well.
Can Invokana Cause Kidney Failure?
That is the troubling suggestion made by QuarterWatch, a publication of the Institute for Safe Medication Practices, in a report released in March 2015.
Independently reviewing serious adverse event reports filed in April, May and June of 2014, QuarterWatch’s analysts identified more than 50 reports in which patients taking Invokana suffered symptoms of impaired kidney function, including total kidney failure. Dehydration, kidney stones, and urinary tract infections were other commonly reported adverse events. In conclusion, QuarterWatch questioned whether or not Invokana’s benefits truly outweighed its potential risks.
On December 4, 2015, the FDA released new information, and a new warning, on Invokana, implicating the drug in a rash of severe urinary tract infections, many of which seem to have spread quickly to the kidneys. From March 2013 to May 2015, the agency identified 19 reports of such infections – all 19 patients required hospitalization. In fact, several required dialysis to forestall the onset of kidney failure.
Potential Risks Of Heart Attack, Stroke
Only two months prior to Invokana’s approval, members of an FDA advisory committee raised serious concerns about the drug’s link to another class of severe complications: cardiovascular events.
Contrasting data from an Invokana clinical trial to the results of a study involving another SGLT2 inhibitor, Dr. Sidney Wolfe, co-founder of the Public Citizen’s Health Research Group, found that patients taking Invokana presented marked elevations in hematocrit, the concentration of red blood cells. He noted that increases in hematocrit can lead to “thrombotic events,” or blood clots, and may in turn result in heart attack and stroke. Wolfe pointed out that thirteen patients in the Invokana trial had experienced “cardiovascular events.”
Doctor Hyon Kwon, an FDA official, backed up Wolfe’s concerns with his own observations of increased cardiovascular risks.
Our Attorneys: Banville Law
The attorneys handling SGLT2 lawsuits, which include Invokana lawsuits, are lead by attorney Laurence P. Banville, Esq. Mr. Banville has extensive experience in the area of mass torts and is active in several mass tort litigations including:
- Zofran child birth defect lawsuits
- Xarelto internal bleeding lawsuits
- Pradaxa internal bleeding lawsuits
- Essure birth control lawsuits
- IVC Filter migration lawsuits
- SGLT2 kidney and ketoacidosis lawsuits
Our lawyers are licensed to practice law in the state of New York, however, we work with other firms on jointly representing cases outside of New York.
Latest Invokana Updates
By Laurence P. Banville
Invokana is a type 2 diabetes drug that has been associated with numerous critical health complications. These complications suffered by patients have led to several lawsuits being filed. Below you will find information about Invokana latest updates as well as lawsuits that are being filed all over the country.
October 3, 2017 – Texas Man Filed Invokana Lawsuit Over Amputation
A Texas man filed an Invokana lawsuit in the U.S. District Court for the District of New Jersey on September 29. In his suit, the man claims that his toe had to be amputated and some of the bone in his foot needed to be removed when he developed a diabetic ulcer after using Invokana. The complaint claims that the amputation, which is a side effect of the diabetes drug, has left him permanently disabled with limited mobility. He states that he was prescribed the drug in May of 2015 but was hospitalized with a severe diabetic ulcer on his left foot in October of 2015.
September 18, 2017 – Invokana Prescriptions May Have Decreased As A Result Of FDA Warning
The FDA issued a warning in May 2017 about a link between the diabetes drug, Invokana, and amputations of the foot, leg, or toes. A new label will be required for the medication with the strongest warning available, a “black box” warning. A recent report that was published by MedPage Today indicated that many doctors and hospital-affiliated medical groups may be avoiding the use of Invokana as a result of the FDA warning. Some doctors are even switching patients currently taking the drug to another diabetes medication. Other doctors are debating if the risks outweigh the benefits. The amputation risk was discovered from the results of the CANVAS study in which the data from 2 clinical trials showed the use of Invokana almost doubled the risk of amputation.
August 31, 2017 – Invokana Lawsuit Filed Alleging Failure To Warn Of Potential Side Effects
An Alabama man filed an Invokana lawsuit in the U.S. District Court for the District of New Jersey on August 18 against drugmaker Johnson & Johnson and its subsidiary Janssen. In his suit, he claims that the companies withheld information from the medical community and consumers regarding the risk of stroke when taking Invokana by not providing adequate label warnings about this potential side effect. He indicates that he began the diabetes medication in July 2015 and after only one month on the drug he suffered an ischemic stroke which the suit claims is a direct result of his use of Invokana. His lawsuit will join many others in the Invokana litigation which raise similar allegations of inadequate warning labels on the diabetes medication.
July 6, 2017 – Study Results Show Increased Risk Of Amputations For Invokana Users
Data from the CANVAS and CANVAS-R studies were announced by Johnson & Johnson regarding its diabetes drug Invokana. The data was published in the New England Journal of Medicine and was presented at the annual meeting of the American Diabetes Association. The data showed that Invokana was successful in reducing the risks of heart attacks and strokes, however, the risk of amputations was increased when using the drug. In both studies (CANVAS and CANVAS-R), the increased risk of amputations was identified and was almost double that of the placebo.
June 16, 2017 – New Study Finds Diabetic Ketoacidosis Risk Doubled For Invokana Users
A new study was conducted by researchers from Brigham and Women’s Hospital in Boston. The results were published on June 8, in the New England Journal of Medicine and they indicate that Invokana and other SGLT2 inhibitors double the risk of suffering diabetic ketoacidosis in comparison to other diabetes treatments or medications. The study used a large claims database of commercially insured U.S. patients and researchers were able to identify over 50,000 patients who received new prescriptions of SGLT2 inhibitors from April 1, 2013, to December 31, 2014. Researchers then looked for reports of hospitalization for diabetic ketoacidosis from among those patients and compared them to those who were prescribed a different diabetes treatment during the same time to obtain their results.
May 11, 2017 – Bellwether Trials Scheduled To Be In September 2018 For Invokana MDL
On May 1st, a case management order was issued which outlined the schedule for selecting bellwether cases for the Invokana MDL. The multidistrict litigation was recently consolidated in December 2016 in New Jersey against Johnson & Johnson subsidiary Janssen Pharmaceuticals. There are more than 230 suits included in the MDL right now, with thousands expected to be filed and included. The complaints allege that the manufacturers didn’t properly warn consumers of the serious health risks associated with the diabetes drug, such as kidney failure, ketoacidosis, heart attacks, and more. Judge Brian Martinotti is overseeing the Invokana MDL and his order also calls for each side to provide recommendations for the trial pool cases by Jan. 5, 2018 and that the court intends to select 3 bellwether trial cases by Jan. 19, 2018.
April 17, 2017 – Invokana Lawsuit Filed Over Side Effect Risks
An Invokana lawsuit was filed in mid-March in U.S. District Court for the District of New Jersey. All seven plaintiffs reside in Texas and all allege that the manufacturers of Invokana failed to warn consumers and the medical community of the possible risks posed by the side effects of the diabetes drug All of the involved plaintiffs for this suit claim to have taken the drug prior to December 2015 when the warning label was changed to include the risk of diabetic ketoacidosis as a side effect, as mandated by the FDA.
March 17, 2017 – Invokana Lawsuit Alleges Wrongful Death
A lawsuit was filed last month in the U.S. District Court for the District of New Jersey by the family of a deceased Florida woman. The suit alleges that the deceased woman passed away due to a fatal stroke which it claims was a side effect of the diabetes drug Invokana. She suffered a stroke in April 2015 after beginning the medication a year earlier in July of 2014. She passed away on December 4, 2015, a few months after suffering the stroke. The year following her death, in June, the FDA required the makers of Invokana and other SGLT2 inhibitors to add to the warning labels to include information about the link between the drug and kidney risks. This newly filed suit will join many others similar suits in the consolidated Invokana MDL located in New Jersey.
February 21, 2017 – Invokana Lawsuit Plaintiffs Fight For Cases To Remain In PA
Janssen Pharmaceuticals, a maker of Invokana and one of the defendants in lawsuits regarding the drug, filed a motion recently requesting the transfer or dismissal of 106 cases in the U.S. District Court for the Eastern District of Pennsylvania. Plaintiffs in these cases are fighting back, arguing that the motion goes against every factor the court should consider. The defendant made the request prior to the creation of the new MDL which is housed in New Jersey. Many plaintiffs had hoped for a consolidation of the 106 cases still pending in PA court into a mass tort.
January 5, 2017 – Janssen Tests Diabetes Drug, Invokana For Other Uses
Janssen Pharmaceuticals should soon have the results of CANVAS as it finishes up the 7-year long study on Invokana meant to test the effectiveness of the drug on reducing adverse cardiac events. Several risks are still associated with the diabetes drug including ketoacidosis which is referenced in many adverse event reports to the FDA and personal injury or wrongful death lawsuits filed against the manufacturer. The CANVAS study included about 4,300 patients and Janssen is hoping for positive study results to hopefully boost sales.
December 13, 2016 – Invokana MDL Created In New Jersey
An order was issued on December 8th by the Judicial Panel for Multidistrict Litigation approving the request to centralize the Invokana litigation to a single court. The litigation will be centralized in the U.S. Court for the District of New Jersey where there are already 29 cases filed. The combined litigation has 55 cases and the panel expects another 44 cases to be filed. All Invokana lawsuits are filed against Janssen Pharmaceuticals, the maker of Invokana and subsidiary of Johnson & Johnson. In order to centralize the litigation, the cases must have a lot in common. All the cases filed claim diabetes drug, Invokana, causes diabetic ketoacidosis and kidney failure.
November 8, 2016 – Motion Filed To Consolidate Invokana Lawsuits In MDL
The U.S. Judicial Panel on Multidistrict Litigation filed a motion in September to consider consolidating all Invokana lawsuits into a multidistrict litigation. The motion indicates that the FDA received multiple reports of kidney damage resulting from the use of the diabetes drug, Invokana, which led to several label changes in May, June, and August of 2016. There are currently at least 56 Invokana lawsuits pending across the country in 11 different courts.
October 5, 2016 – FDA Approves Extended-Release Diabetes Drug, Invokamet
Diabetes drug Invokamet was recently approved by the FDA for expanded use. Invokamet XR is an extended-release drug meant to be used for the treatment of type 2 diabetes. It falls into the same class of drugs, SGLT2 Inhibitors, as Invokana, which was the first of its kind approved by the FDA in 2013. The prescribing information comes with a box warning for lactic acidosis. The drug should not be used for the treatment of type 1 diabetes.
September 14, 2016 – Janssen Will Present Abstracts On Invokana At Annual Diabetes Meeting
Janssen announced on Friday, September 9th that nine presentations on Invokana will be featured at the 2016 European Association for the Study of Diabetes Annual Meeting. Some of the topics covered will include clinical findings on the effects of Invokana in combination with phentermine on weight management in overweight and obese adults and clinical findings that show Invokana slows progression of renal function decline independent of glycaemic effects. The meeting will take place in Munich, Germany on September 12-16.
August 26, 2016 – Arizona Woman Files Invokana Lawsuit After Developing Diabetic Ketoacidosis
A female plaintiff filed a lawsuit on July 25th in the U.S. District Court for the District of New Jersey. Her complaint alleges that the defendants, the manufacturers of the diabetes drug Invokana, were negligent in that they failed to warn or concealed from consumers the potential side effects of the drug. The plaintiff claims to have developed Diabetic Ketoacidosis while using Invokana and continues to suffer from injuries as a result. The Arizona resident is one of many who have filed suit claiming they were not warned of the life-threatening risks the new-generation diabetes drug posed, and that the manufacturers should have included warnings on the label. The FDA has released several safety communications since their approval of the drug in 2013 but did not require a warning about ketoacidosis on the label until December of 2015.
April 8, 2016- California Woman Who Suffered Invokana Kidney Failure Seeks Punitive Damages
A California woman is suing Janssen Pharmaceuticals and Johnson & Johnson for injuries she allegedly suffered due to the use of the type 2 diabetes drug Invokana. She is seeking over $75,000 in damages for kidney failure she alleges Invokana caused. The plaintiff stated she was taken to hospital in April 2014 and May 2015 for acute kidney injury and acute kidney failure after she had started taking the drug. She alleges that had the defendants fully disclosed the risks associated with the drug, she would not have used it.
March 18, 2016- $10 Million Invokana Lawsuit Filed By Texan Woman
A woman from Texas filed a lawsuit against the manufacturers of Invokana, alleging that she suffered serious injuries after she took the drug for type 2 diabetes. The woman is seeking over $10 million for compensatory and punitive damages. Her lawsuit was filed in the U.S. District Court for the District of New Jersey.
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