Two years ago, the US Food & Drug Administration informed patients and medical providers that Invokana, along with other SGLT2 inhibitors, could cause a condition known as diabetic ketoacidosis, in which the blood becomes overburdened by acidic molecules. Lawsuits followed after.
Leg, Foot & Toe Amputation Risks
But a more recent warning from federal health regulators has revived both the debate around Invokana’s safety and the litigation against Janssen Pharmaceuticals, the drug’s manufacturer. In March of 2017, the FDA announced that new study results had confirmed a link between Invokana and lower limb amputations. As clinical findings demonstrate, type 2 diabetes patients taking Invokana are around twice as likely to undergo an amputation procedure than people taking placebo, even when those placebo patients also have type 2 diabetes and thus already live at risk of leg, foot and toe amputations. Amputations of the toe and mid-foot appear to be most common, government experts say, although leg amputations have also been reported.
Double the risk. That’s a big difference. As a result, Janssen Pharmaceuticals was ordered to add a new warning to the label for Invokana, notifying patients and doctors in bold print that the medication can cause life-altering amputations. Nor was this your average warning. The FDA told Janssen to add a “black box warning,” which signifies the federal agency’s highest level of risk.
On May 15, 2015, the US Food & Drug Administration announced that SGLT2 inhibitors, a new class of type 2 diabetes medications that inhibit kidney function, may lead to “ketoacidosis,” a condition in which the body produces abnormally elevated amounts of a blood acid. Left untreated, ketoacidosis can lead to diabetic coma and death.
The agency cautioned patients currently taking Invokana and Farxiga, along with drugs with the same mechanism of action to watch for symptoms of ketoacidosis, including:
- disorientation or confusion,
- excessive fatigue and drowsiness,
- nausea and vomiting,
- abdominal pain or
- difficulty breathing.
A form of ketoacidosis, diabetic ketoacidosis, is common among type 1 diabetics, but rare among patients with type 2 diabetes. After receiving a surprising amount of adverse event reports in which patients prescribed SGLT2 inhibitors like Invokana suffered near-fatal cases of the condition, the FDA announced that it would continue to closely monitor adverse event reports and consider further regulatory action.
After FDA Intervention, Patients File Lawsuits
After tracking adverse event reports for nearly eight months, the FDA took action in December 2015, adding a new warning for ketoacidosis to Invokana’s label. But the agency also alerted patients to a second, previously unidentified risk: urinary tract infections. While urinary tract infections are not uncommon, and generally pose little long-term health risks, patients on Invokana appear more likely to contract severe forms of infection, ones that can quickly spread into the bloodstream or to the kidneys. Cases of patients requiring dialysis, to prevent total renal failure, have been reported.
As allegations mount, accusing Invokana’s manufacturer Janssen Pharmaceutical of failing to warn patients of the drug’s severe risks, individuals who suffered injury have begun to file ketoacidosis lawsuits. With newer revelations, another group of patients, those who were forced to undergo a foot, leg or toe amputation, are beginning to file their own claims. Many of these lawsuits have been consolidated in the US District Court for New Jersey, a federal court where District Judge Brian Martinotti is currently presiding over more than 900 Invokana lawsuits.
Legal experts believe many others will step forward in the coming months, pursuing compensation for the harm they’ve suffered. Tragically, we’ve already spoken to several widows and widowers who believe their loved ones died as a result of Invokana’s side effects. For these grieving families, wrongful death lawsuits may be possible.
Evidence Of Kidney Damage Still Emerging
QuarterWatch, a publication of the Institute for Safe Medication Practices, reviewed recent FDA data submitted to the agency since Invokana’s approval in 2013. Between April and June of 2014 alone, the nonprofit identified “457 serious adverse event reports, including 5 different adverse effects directly or indirectly related to the renal [kidney] toxicity of canagliflozin [Invokana’s active ingredient.”
QuarterWatch found 54 reports in which Invokana patients suffered kidney failure or impairment, 11 reports listing kidney stones as a side effect and 50 cases of urinary tract infection. While the implications of SGLT2 inhibitors for kidney health are far from certain, QuarterWatch’s editors were led to question whether the drug has any “clinical benefits, and whether those benefits outweigh its risks.”
For more information on Invokana’s possible kidney risks, click here.
Why Are Heart Risks Mentioned?
Similar concerns were voiced in 2013, only two months before Invokana‘s FDA approval. In a hearing for the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, noted public health advocate Sidney Wolfe MD challenged the assumption that Invokana presented patients any benefits over and above those already offered in older diabetes drugs.
Noting that Invokana’s approval was based only on a demonstration of “surrogate efficacy,” rather than a real reduction in adverse diabetes-related complications, Wolfe presented data indicating that Invokana’s active ingredient could drastically increase the concentration of red blood cells. According to Wolfe, this higher concentration, or “hematocrit,” could, in turn, lead to dangerous blood clots and stroke.
At the same meeting, FDA official Hyon Kwon MD raised his concerns over an elevated rate of “early cardiovascular events,” primarily ischemic stroke, suffered by patients taking Invokana during an early clinical trial conducted by Janssen Pharmaceutical.
To learn more about Invokana’s potential link to cardiovascular risks, follow this link.
Breaking Invokana Lawsuit Updates
By Laurence Banville
Below is a listing of monthly news items relevant to Invokana lawsuits.
February 23, 2016 – 2015 Saw Huge Increase In Ketoacidosis Cases Linked To SGLT2 Inhibitors
The Institute for Safe Medication Practices continues to monitor Invokana side effect reports closely. In its newest issue of QuarterWatch, the nonprofit notes a significant increase in prescriptions for all SGLT2 inhibitors. Between April and June of 2015, doctors wrote at least 1.1 million outpatient scrips for Invokana. Despite lagging far behind, the drug’s main competitors, Farxiga and Jardiance, saw their own bumps, with 411,000 and 136,000 prescriptions respectively in the same quarter.
As one might expect, more prescriptions equaled more side effect reports. Using data submitted to the Food & Drug Administration during all of 2015, QuarterWatch was able to identify 7,744 adverse event reports related to SGLT2 inhibitors, with the lion’s share, nearly 71%, apportioned to Invokana. Diabetic ketoacidosis (DKA) cases also seem more prevalent, with:
- 168 cases of diabetic ketoacidosis associated with Invokana
- 80 cases associated with Farxiga
- 12 cases associated with Jardiance
That’s 260 DKA cases total, an astounding 1200% more than the FDA itself observed between March 2013 and June 6, 2014.
Contact Banville Law’s Invokana Attorneys
With the serious safety concerns of SGLT2 inhibitors now coming to public attention, Banville Law has begun to provide free consultations to Invokana patients who believe their severe complications were caused by the drug. Banville Law is devoted to protecting the rights of American patients. Our experienced attorneys offer aggressive representation to clients harmed by dangerous pharmaceutical drugs and medical devices. To learn more about your legal options, contact Banville Law’s Invokana attorneys.
If you took Invokana, Jardiance, Farxiga or any other SGLT2 inhibitor and experienced ketoacidosis, kidney failure, stroke or heart attack, contact Banville Law’s experienced attorneys to learn more about your legal options. Our attorneys are here to answer your questions, at no cost and no obligation.
More Invokana Information