Invokana, a potent new drug manufactured by Johnson & Johnson’s Janssen Pharmaceutical, has been hailed as a “revolution” in the treatment of type 2 diabetes. But according to the US Food & Drug Administration, Invokana’s potential benefits for diabetic patients may come at a significant risk. In a series of safety announcements, the FDA has progressively strengthened Invokana’s warning label, alerting patients to increased risks for bone fracture, urinary tract infections and ketoacidosis, a severe condition that can be fatal.
Early warnings and independent reviews have also surfaced, suggesting that Invokana may be linked to increased risks of major cardiovascular complications and kidney damage. But patients, many of whom have suffered severe injuries, aren’t taking these developments sitting down.
Janssen Pharma Hit With Invokana Lawsuits
Two former Invokana patients have kicked off what legal experts believe will become a major product liability litigation. In December of 2015, Arthur Portnoff and Luana Jean Collie officially filed suit against Janssen Pharmaceuticals, the Johnson & Johnson subsidiary behind Invokana. Both plaintiffs say they were prescribed the drug to help manage their blood sugar levels, assured by physicians it was a safe, effective choice. Only months later, both were struggling against ketoacidosis, a condition caused by dangerously elevated blood acid levels.
Portnoff and Collie say Janssen actively concealed Invokana’s many side effects from patients and health professionals, even marketing the drug for unapproved indications. Sales, in their words, overshadowed safety, as Janssen exchanged public health for greater profits.
In the meantime, the FDA continues to receive reports of patients being hospitalized with debilitating cases of ketoacidosis after being prescribed Invokana.
Can You File Suit For Drug’s Side Effects?
Thousands of patients may still be in danger. For those already harmed, filing an Invokana lawsuit may be the only answer. The attorneys at Banville Law are dedicated to helping these patients and families pursue the justice they deserve. Our experienced dangerous drug lawyers are devoted to championing the rights of patients across the nation. If the claims leveled against Invokana’s manufacturer are true, any patient who took the drug and suffered:
- diabetic ketoacidosis,
- kidney failure,
- another kidney function complication,
- cardiovascular events, like stroke or heart attack,
- severe urinary tract infection,
- broken bones
may be eligible to bring a claim against the company.
Invokana Lawyers: Experience & Insight
Banville Law’s experienced team of product liability lawyers is led by Laurence Banville, Esq. A native of Ireland, Mr. Banville secured his law degree from the University College Dublin, graduating with a GPA equivalent of 4.0 and receiving President’s honors.
He soon moved to the United States, where he began refining his skills at a number of law firms. Laurence gained crucial insights working as a defense attorney for asbestos manufacturers, learning how large corporations attempt to shield themselves from product liability. He brings this unique experience to every one of his clients here at Banville Law, a firm he leads as our Managing Partner.
Is A New Diabetes Drug, Harming Patients?
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:
- Invokamet, a combination of Invokana’s active ingredient canagliflozin and metformin, an older diabetes drug; also manufactured by Johnson & Johnson’s Janssen Pharmaceutical
- Farxiga, a product manufactured by AstraZeneca with the active ingredient dapagliflozin
- Xigduo XR, also manufactured by AstraZeneca, a combination of dapagliflozin and metformin hydrochloride
- Jardiance, active ingredient empagliflozin, is manufactured by Boehringer Ingelheim and Eli Lilly.
- Glyxambi, also made by Boehringer Ingelheim and Eli Lilly, is a combination of empagliflozin and linagliptin, an older diabetes medication
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.
Ketoacidosis: Are Type 2 Diabetes Patients Being Poisoned By Their Medication?
The FDA found that toxic acids, a product of the body’s struggle to convert fat into a fuel source, were abnormally elevated in many Invokana patients. All of these patients required hospitalization or emergency medical interventions.
A form of ketoacidosis, diabetic ketoacidosis, is fairly common among patients with type 1 diabetes. According to the American Diabetes Association, diabetic ketoacidosis occurs when the body’s insulin levels become dangerously low. Without the vital hormone, cells are unable to break glucose down into energy. The body turns instead to fat cells, which can be converted into an alternative form of cellular energy. But the alternative energy source, ketones, are toxic acids. Released into the bloodstream, ketone accumulation can lead to diabetic ketoacidosis (DKA), a condition marked by debilitating symptoms. DKA is a life-threatening, medical emergency. Untreated, the condition can be fatal.
But diabetic ketoacidosis is extremely rare in patients with type 2 diabetes, and the increased incidence among Invokana patients with type 1 raised warning flags for the FDA. As a result, the agency continues to monitor adverse event reports closely and has begun to consider regulatory action.
Warning Signs: Researchers Highlight Potential Kidney & Cardiovascular Risks
Approved by the Food & Drug Administration on March 29, 2013, Invokana’s release on the US market met with resounding success almost immediately. According to QuarterWatch, an independent drug safety review organization, 426,859 outpatient prescriptions were written for Invokana between April and June of 2014 alone.
But beyond observing a marked increase in sales, QuarterWatch also identified a troubling trend: numerous adverse event reports involving impaired kidney function. To learn more about this potential danger, visit our “Invokana Kidney Failure” page.
Even before Invokana’s approval, independent reviewers and federal regulators were raising major concerns over the drug’s effect on cardiovascular health. In a 2013 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, three experts highlighted clinical trial data revealing a potential association between Invokana and major “thrombotic” events, or blood clots, and other heart complications.
Contact Banville Law’s Personal Injury Lawyers
If you were diagnosed with ketoacidosis, kidney impairment or a cardiovascular condition after beginning a course of treatment that involved Invokana, contact the personal injury lawyers at Banville Law for a free consultation. You may be entitled to significant financial compensation.
Banville Law believes that your voice needs to be heard. We believe that pharmaceutical manufacturers should be held accountable for misleading patients, along with the American public, and that future patients deserve to be protected. We are willing to fight for justice, with all the knowledge, understanding and resources at our disposal.