A class of type 2 diabetes drugs, known in the medical community as SGLT2 inhibitors, has been linked to potentially life-threatening side effects, including foot and leg amputations.
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Several brand name drugs, including Invokana, are now being closely monitored by the US Food & Drug Administration, which has already added a prominent warning to the drugs’ labeling about the risk of ketoacidosis, a severe medical condition involving elevated blood acid levels. And more recently, a second major warning was announced for an increased risk of lower limb amputations.
Hundreds of Invokana lawsuits have already been filed by Invokana patients who say they suffered diabetic ketoacidosis or leg and foot amputations after being prescribed the drug.
In response to these developments, the experienced dangerous drug lawyers at Banville Law have begun to investigate potential legal claims. Our attorneys are offering free case eligibility evaluations to patients who believe that Invokana, or any other SGLT2 inhibitor, may have led to ketoacidosis.
Other SGLT2 inhibitors, drugs like Invokamet, Farxiga and Jardiance, all present an increased risk of ketoacidosis, according to the FDA. In coming months, it’s likely that more patients will begin to file lawsuits involving these additional SGLT2 inhibitors.
Canagliflozin, manufactured under the brand name Invokana by Johnson & Johnson subsidiary Janssen Pharmaceutical, is one of many new-generation type 2 diabetes drugs. Known as SGLT2 inhibitors, these drugs knock out one of the kidney’s natural functions: filtering excess glucose from urine.
In patients with type 2 diabetes, the body’s cells have become “insulin resistant,” unable to utilize a hormone that converts glucose, or blood sugar, into energy. Over time, the elevated blood glucose levels that result can lead to kidney, eye, nerve and heart damage.
Invokana forces kidneys to excrete blood glucose in a patient’s urine, rather than sending the sugars back into the blood stream as they would without the drug’s influence. To learn more about the science behind SGLT2 inhibitors, which may explain some of its potential health risks.
On March 15, 2015, the FDA released a major safety announcement, warning the health community about a potentially life-threatening Invokana side effect. According to the agency’s press release:
“type 2 diabetes medicines canagliflozin, dapagliflozin and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”
The FDA has cautioned patients currently taking SGLT2 inhibitors to watch for signs of ketoacidosis, which include:
In a search of its Adverse Event Reporting System, the FDA identified at least 20 cases of ketoacidosis, diabetic ketoacidosis, metabolic acidosis or ketosis among patients prescribed SGLT2 inhibitors including Invokana between March of 2013 and June of 2014. All of these patients required emergency medical intervention or extended hospitalization. The agency reports that it has continued to receive adverse event reports linking Invokana and other SGLT2 inhibitors to these potentially fatal conditions.
After nearly 10 months of review, the FDA decided to take action, adding a formal warning to every SGLT2 inhibitor, including Invokana, about diabetic ketoacidosis. According to a press release issued on December 4, 2015, the new warnings will encompass ketoacidosis, “the risks of too much acid in the blood,” as well as a risk for “serious urinary tract infections.”
A review of FDA databases turned up 73 cases of ketoacidosis between March 2013 and May 2015. But the analysis also highlighted another risk, one that had slipped under the radar until now. At least 19 patients had suffered from “life-threatening blood infections […] and kidney infections.” Apparently, these infections begin as urinary tract infections and then spread, becoming more virulent, and potentially deadly, in the absence of proper medical attention. Several patients even suffered kidney failure, requiring intensive care and dialysis.
Whether ketoacidosis or kidney failure, these severe side effects invariably require hospitalization, according to the FDA. Going forward, drug manufacturers are being required to conduct enhanced studies on the risks of SGLT2 inhibitors and will have to follow up with patients who report severe side effects for the next 5 years.
In a new safety alert, the FDA has announced updated warnings for two SGLT2 inhibitors, Invokana and Farxiga. Over the last two years, both drugs have been implicated in at least 101 confirmed cases of acute kidney injury, a syndrome in which kidney function deteriorates suddenly. The condition, also known as AKI, can lead to total organ failure and even death if left untreated.
Long-term safety data is sorely lacking, reports the Institute for Safe Medication Practices (ISMP), a nonprofit drug watchdog that’s been on Invokana’s case since before the drug’s approval. But the drug’s popularity can’t be doubted. Data from the leading clearinghouse for pharmaceutical sales shows that Invokana broke 1.1 million outpatient prescriptions in the second quarter of 2015, a three-month period between April and June. Other SGLT2 inhibitors have seen similar, though not quite blockbuster, success. Farxiga reached 411,000 prescriptions in the same period, while Jardiance was prescribed 136,000 times.
As more and more patients were exposed to SGLT2 inhibitors, the ISMP noted a proportionate increase in adverse event reports submitted to the Food & Drug Administration. During 2015, the FDA reportedly received:
Cases of ketoacidosis, the ISMP says, still represent a relatively small fraction of these total reports, but since the prevalence of complications has increased in step with total prescriptions, the numbers likely support a causal link between these drugs and DKA.
Remember that the FDA could identify only 73 cases of ketoacidosis between 2013 and May of 2015, and further, that those 73 cases were likely split between Invokana, Farxiga and Jardiance. For the full calendar year of 2015, on the other hand, the ISMP identified:
Far more prevalent are genital fungal infections, like yeast infections, which were widely reported in clinical trials conducted prior to Invokana’s approval. In those studies, 11.4% of female subjects and 3.7% of males experienced infections. Since SGLT2 inhibitors increase the amount of glucose present in the bladder and urine, this side effect is not altogether surprising. Fungi favor environments high in sugar, which can be an energy source for virulent bacteria as well. As we mentioned earlier, the FDA has observed a number of serious urinary tract infections in Invokana patients. While those infections are caused by bacteria, unlike fungal infections, the increased incidence of both infection types among patients taking SGLT2 inhibitors may have, at the bottom, the same cause.
While the FDA’s recent emphasis on kidney failure has surprised many in the medical community, Invokana has actually been linked to various forms of renal damage for the last year.
In May 2015, the Institute for Safe Medication Practices reported that “early signals for [Invokana] raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.”
Reviewing adverse event reports submitted to the FDA, ISMP identified a total of 457 “serious adverse event reports,” including severe impairment of kidney function. The reports, all submitted during the second quarter of 2014, included:
Perhaps most surprisingly, the ISMP wrote that many of these potential side effects could have been “reasonably anticipated,” in light of the drug’s effects on kidney function and the results of clinical data. ISMP reports that studies conducted prior to Invokana’s approval using animal subjects revealed evidence of “long-term kidney damage, kidney and testicular cancers and bone abnormalities.”
In March 2013, a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee convened to discuss the safety and efficacy of Invokana. Noting that the drug’s approval was based on studies that indicated “no evidence of any improved clinical outcomes” over older diabetes medications, noted patient advocate Dr. Sidney Wolfe highlighted “a number of serious safety signals identified in [Invokana’s] clinical trials.”
Wolfe emphasized an apparent increase in the rate of “cardiovascular events,” particularly blood clots which can quickly lead to stroke. Using data from studies on another SGLT2 inhibitor, Wolfe demonstrated how patients taking Invokana experienced much higher increases in red blood cell concentration, a common precursor to the development of blood clots.
Two FDA officials seconded Wolfe’s concerns, noting increased rates of cardiovascular “events” among patients prescribed Invokana. Dr. Mat Soukop, an FDA biostatistician, cited a clinical trial in which patients administered the drug were 6.9 times more likely to experience cardiovascular complications than patients given a placebo.
Invokana was approved two months later.
In a strange twist, one of Invokana’s direct competitors is being floated as a treatment for diabetes-related cardiovascular complications. Jardiance, an SGLT2 inhibitor manufactured by Eli Lilly, has been shown to cut heart disease deaths in patients with type 2 diabetes by a significant margin. Diabetes is a primary contributor to cardiovascular complications, including stroke and heart attack, but Jardiance seems to help. A recent clinical trial, published in the November 2015 edition of the New England Journal of Medicine, found that Jardiance reduced the risk of death from cardiovascular causes by 38%.
Patients used for the trial were picked specifically because they already had cardiovascular diseases, and thus lived at an increased risk of heart attack and stroke. The results, however, were far more ambivalent than the reduction in total deaths would imply. The incidence of stroke actually increased among Jardiance patients, while the reduction in heart attacks was deemed “statistically insignificant.” So what did Jardiance do? It reduced the likelihood of heart failure when the heart loses the ability to pump blood properly.
After the study’s publication, stock in Eli Lilly jumped by 7%, according to the New York Times. Without similar data in support of Invokana, stock in Janssen’s parent company Johnson & Johnson fell by 1% the same day.
After eight months of heightened vigilance, the FDA has decided to strengthen the warning label on Invokana – and all other SGLT2 inhibitors – to reflect evidence of the drugs’ link to ketoacidosis. In a press release announcing the decision, the agency wrote:
“A U.S. Food and Drug Administration (FDA) safety review has resulted in added warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood”
Any patients who notice symptoms of ketoacidosis, like nausea and fatigue, have been advised to stop taking Invokana immediately and seek medical attention. The agency emphasized the condition’s severity and noted that its onset may not be associated its other common warning sign: high blood sugar.
The FDA is requiring drug manufacturers, among them Janssen Pharmaceuticals, the company responsible for Invokana, to conduct a five-year study on “spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors.”
More surprising, the FDA has decided to add a second new warning to Invokana’s label for severe urinary tract infections. In reviewing adverse event reports, the agency identified 19 patients who had contracted “life-threatening blood infections
[…] and kidney infections.” Apparently, these infections began as fairly routine UTIs, but then quickly spread to the bloodstream or kidneys.
The FDA believes Invokana has something to do with this increased virulence, but no specific mechanism has been suggested to explain the link. Each of the 19 patients required hospitalization, and several were placed on dialysis to prevent kidney failure.
Canagliflozin is the active ingredient in Invokana, and in combination with metformin, an older diabetes drug, is also marketed by Johnson & Johnson’s subsidiary Janssen Pharmaceutical as Invokamet.
But the FDA made clear that other SGLT2 inhibitors also carried the risk for ketoacidosis:
In its press release, the FDA said that it was “continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.”
As a result of two large clinical trials, the US Food & Drug Administration has required Janssen Pharmaceuticals, the manufacturer of Invokana, to place the most strict warning label on the drug to warn users and medical professionals about an increased risk of leg and foot amputations.
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.
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.
Unlike traditional diabetes medications, Invokana operates independently of insulin, a hormone that helps cells convert blood glucose, or sugar, into energy. Rather than altering the function of insulin, Invokana acts on a patient’s kidney. Along with a slew of other so-called SLGT2 inhibitors, Invokana forces the kidney to excrete blood glucose, which is dangerously elevated in diabetics, in a patient’s urine.
Following Invokana’s approval in 2013, a number of other SLGT2 inhibitors quickly came to market:
These drugs were approved to widespread acclaim, touted as an entirely new way to tackle type 2 diabetes. But after reviewing reports of serious adverse events, the FDA identified a troubling trend: patients prescribed SLGT2 inhibitors were suffering from a severe condition, ketoacidosis, at alarming rates.
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:
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.
But a different question, one of a legal nature, has also come into play. Some attorneys have referred to the potential Invokana litigation as a “class action,” while others only write of “individual” personal injury lawsuits.
At Banville Law, our attorneys do not believe that the Invokana litigation will proceed as a class action. We intend to bring individual lawsuits on behalf of our clients.
Just as the human body is unique, each patient potentially harmed by Invokana will have been injured in a different way. Specifics matter, in law as in all things. We believe that each patient deserves personalized attention and unique consideration. As a result, we believe that individual claims should be treated on their own merits.
In the typical class action, one or more “representative” individuals file suit, generally against a larger corporate defendant, on behalf of a much wider group. This group is known as a “class,” and each member’s claim must satisfy certain conditions:
But just as class members share allegations, they also must share the court award or settlement in the event that the case is won. And while the total award in a class action is often very large, the amounts ultimately received by any class member can be minuscule. In fact, in most class actions, many members never receive any form of settlement.
Class actions are most common in relation to consumer product recalls and alleged stock fraud.
Rather than pursuing a class action, Banville Law is currently investigating individual Invokana claims. But since the legal community expects many such SGLT2 inhibitor lawsuits to be filed, it’s likely that many will be “consolidated” into a Multidistrict Litigation (MDL).
In these “mass torts,” claims involving similar allegations against a single defendant are transferred to one Federal Court, and overseen by one judge. The individual cases will then proceed together, but only for “discovery” (in which evidence is gathered) and other pre-trial proceedings. After common questions of fact are determined, the cases can be sent back to the original courts in which they were filed. Plaintiffs can then decide to accept an Invokana settlement offer or proceed to trial, but make those decisions for themselves.
Like class action, MDL takes a significant burden off the court system, but still allows individual plaintiffs to determine the outcome of their own cases, rather than being tethered to the decisions of “representative” plaintiffs.
For now, Invokana’s patient safety remains in serious doubt. But with an estimated 2 million Invokana prescriptions written in 2014 alone, numerous Americans may be at risk of developing the drug’s severe potential side effects.
For patients who took Invokana and suffered ketoacidosis, kidney failure or any other serious adverse event, legal action may be possible. The legal community anticipates that many injured patients may choose to file lawsuits, and while it is unlikely that an Invokana litigation would result in class action, a high volume of claims may increase the likelihood of future Invokana settlements.
The experienced attorneys at Banville Law are here to help. If you believe that Invokana caused ketoacidosis, kidney failure or cardiovascular complications, contact our lawyers today for a free consultation.
Continue Reading: Invokana Lawsuit Commercials: Drug Linked To Amputation, Kidney Failure
U.S. National Library of Medicine Clinical Trials: SANagliflozin cardioVascular Assessment Study
Institute for Safe Medication Practices: QuarterWatch Reports
Invokana Manufacturer Website: What is Invokana?