Showered with positive hype during its release in 2013, the new blood glucose-lowering medication Invokana has quickly gained a foothold in the diabetes treatment market. But Invokana’s mechanism of action, which targets the kidneys rather than the pancreas or liver, has now been linked to a series of dangerous side effects. To date, researchers at the US Food & Drug Administration have slapped Invokana with two prominent warnings:
- Diabetic Ketoacidosis – elevated levels of blood acid
- Lower Limb Amputations
Both complications can be life-altering, but shockingly, a few of Invokana’s other possible side effects—kidney damage and an increased risk of heart attack and stroke—had already been brought up as troubling before the drug was even approved.
Panel Questions Invokana’s Cardiovascular Safety
On January 10, 2013, in order to settle the question of Invokana’s approval status, the FDA held a meeting with a voting panel of respected doctors and medical researchers from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
The panel was presented with a detailed drug background on Invokana’s active ingredient and in-depth analyses of results from clinical trials and other relevant studies. When panel members were asked to vote and publicly discuss their opinions on Invokana’s efficacy and safety, 8 out of 15 spoke up about “lingering concerns” they had regarding the drug’s possible cardiovascular risks.
Patients Have Higher Risk of Blood Clots, Heart Attack, Stroke
The panel was particularly worried over results from one clinical trial in which patients experienced an elevated risk of blood clots leading to heart attack or stroke within 30 days of taking Invokana.
The effect was generally judged to be significant, as it didn’t occur in patients ingesting a placebo, and was termed an “early risk signal” because the heightened risk tended to fade after the initial month of starting Invokana. But the panel was still concerned, and it’s not hard to see why—just one heart attack or stroke could already have a permanent negative impact on health or even take a patient’s life, so one month of elevated risk is definitely enough danger to take seriously.
Risks A “Significant Problem” According To Consumer Advocate
As this meeting was open to the public, others in the medical community were also allowed to share their thoughts. A noted consumer advocate, Dr. Sidney Wolfe, who founded the nonprofit Health Research Group, was convinced that Invokana’s cardiovascular risks were a “significant problem” and offered some insight into their possible origin.
Invokana is known to have a strong diuretic effect, causing frequent urination and often markedly lowering the body’s fluid levels. According to Dr. Wolfe, this causes imbalances in normal blood cell-to-fluid ratio and may thicken the blood, which can increase the risk of complications like blood clotting.
FDA Orders Janssen To Conduct More Safety Studies
In the end, despite having reservations, the panel voted 10 to 5 in favor of approving Invokana. But even some members who gave “yes” votes described feeling uneasy about the lack of long-term studies presented by the manufacturer. In response to these concerns from the panel, the FDA would not grant approval for Invokana unless Janssen Pharmaceuticals agreed to perform a series of 5 comprehensive post-marketing safety studies:
- A cardiovascular outcomes trial
- An enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes
- 2 pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study
- A bone safety study
The FDA allotted several years for the manufacturer to complete these studies—for example, the cardiovascular trial is slated to wrap up in June 2017.
But in the meantime, Invokana is on the market and widely-prescribed by doctors, potentially exposing many patients to risks they may not even know about.
Even though the possibility of patients suffering from elevated cardiovascular risks was such a major point of contention among the approval panel, Janssen Pharmaceuticals deemed the clinical trial data “insignificant” and excluded any mention of potential cardiovascular problems on Invokana’s label.
Approval Panel Also Wary Of Kidney Risks
The active ingredient in Invokana, canigliflozin, belongs to a class of drug molecules called the sodium-glucose co-transporter2 (SGLT2) inhibitors. These molecules lower blood glucose by forcing the kidneys to excrete sugar in the urine—that is, they block the reabsorption of glucose into the bloodstream, a key task that the kidneys routinely perform in healthy patients.
With a mechanism of action that inhibits normal kidney function, it’s not surprising that possible kidney damage was another prominent topic among Invokana’s approval committee.
Of the 5 panel members who felt that Invokana was unfit for market release, 3 explained that they were primarily concerned about the drug’s potential for causing kidney problems. For example, Dr. Peter Savage said that he couldn’t vote to approve Invokana in good conscience because he wasn’t convinced that“[Invokana] wouldn’t…actually damage the kidneys with long-term urinary tract infections and so forth.”
Kidney Problems Prevalent In FDA Patient Reports
Just recently, a nonprofit consumer safety group called the Institute for Safe Medication Practices (ISMP) shared an analysis of patient complaints to the FDA that suggests that the approval panel’s concern over adverse kidney effects may have been justified.
In the ISMP’s “QuarterWatch” publication, the organization monitors adverse FDA patient reports regarding potentially dangerous prescription drugs. For Invokana, a total of 457 patient complaints were submitted within the second quarter of 2014, which translates into a rather high 1 to 100 ratio of adverse reports to total prescriptions (426,859).
Taking an in-depth look at the adverse reports, the ISMP discovered that an alarming number of them contained “serious injuries involving kidney function,” which the organization placed into 5 categories of health problems “directly or indirectly related to the renal toxicity of canagliflozin”:
- Kidney impairment (includes acute or chronic kidney failure)
- Dehydration and other fluid imbalances
- Urinary traction infections
- Formation of kidney stones
- Unexplained weight loss
The ISMP also discussed numerous research studies focusing on Invokana’s renal (kidney-related) effects.
Medical Research On Invokana Points To Kidney Harm
Multiple animal studies on Invokana revealed a prevalence of kidney impairment and a marked increase in risks of developing kidney cancer and various kidney abnormalities / deformities. Animal studies, though often an imperfect analogy to human studies, can act as a useful initial investigation as they are much more readily-obtained than long-term human clinical trials.
Indeed, the human clinical trials performed so far also suggest that Invokana negatively impacts kidney function. In these studies, Invokana patients were seen to exhibit a statistically significant decrease in kidney function, measured by “eGFR” (estimated glomerular filtration rate, a common diagnostic for kidney disease).
Within only 6 weeks of starting an Invokana prescription, the test subjects experienced a 4-6% reduction in eGFR, while those taking a placebo only showed a 2% decrease. Additionally, about 4% of patients on high-dose Invokana tablets (300 mg rather than the low dose 100 mg offering) suffered from an alarming 30% decrease in eGFR.
The ISMP also mentioned that after the FDA reviewed the above study, the agency had proclaimed: “[T]he volume depletion and corresponding reduction in eGFR …places patients at increased risk for clinically significant episodes of acute kidney injury.”
Patients Afflicted By Side Effects Turn To Legal Action
As we’ve seen, preliminary research had the FDA and Invokana’s approval panel worried that possible side effects of Invokana could cause significant harm to patients.
Yet just by promising to conduct more safety studies, Janssen Pharmaceuticals was still allowed to release the drug on the U.S. market. While the medical community continues to wait for this research to be completed, countless innocent patients have already been taking the drug.
900+ Lawsuits Consolidated In New Jersey
And only a few years after Invokana’s release, hundreds of patients have already filed lawsuits against Janssen. In over 900 Invokana lawsuits, patients and their loved ones accuse Janssen of concealing the type 2 diabetes drug’s risks. The patients describe their own horror stories in detail, writing how a prescription for Invokana led to severe complications, from diabetic ketoacidosis and kidney failure to a leg, foot or toe amputation.
Due to their striking similarities, most of these complaints have now been consolidated in a New Jersey federal court, where the claims will move through pre-trial proceedings as a coordinated group.
While this growing litigation is progressing quickly, hundreds of injured patients and families may still be eligible to file an Invokana lawsuit of their own. If you think you may have an Invokana case, you can get help today. Banville Law is now offering free case evaluations to patients harmed by Invokana or the related drugs Invokamet, Farxiga, and Jardiance. Our experienced, compassionate legal team will be happy to answer all of your questions about a potential claim.