Invokana: Innovative Medicine Or Dangerous Drug?

Invokana: Innovative Medicine Or Dangerous Drug? 2017-04-25T12:04:43+00:00

Invokana, a pill medication for type 2 diabetes that was approved by the FDA in 2013, has come under fire for a number of dangerous possible side effects:

  • Ketoacidosis, a rise in blood acidity that can lead to hospitalization, coma, or death
  • Kidney impairment that can result in kidney failure
  • Severe urinary tract infections that can spread to the kidneys or into the bloodstream
  • Potentially fatal cardiovascular events such as blood clots, heart attack, or stroke
  • Bone problems such as decreased bone mineral density and increased fracture risk

Should Invokana Even Be On The Market?

Though several of these adverse effects were brought up as a major cause for concern during Invokana’s approval meeting, the drug was released anyway, after the manufacturer promised to conduct a host of long-term safety studies.

But these studies are still in progress, and meanwhile, Invokana is prescribed to an estimated 4 million Americans yearly. Numerous Invokana patient complaints to the FDA as well as troubling clinical trial data have necessitated multiple FDA safety alerts.

And now, patients who developed serious health problems that they say were caused by Invokana or related drugs have started filing lawsuits to seek compensation for their pain and suffering.

How SGLT2 Inhibitors Lower Blood Sugar

The active ingredient in Invokana, canagliflozin, belongs to a new class of drug molecules called sodium-glucose co-transporter2 (SGLT2) inhibitors, which moderate blood glucose by targeting the kidneys.

Normally, the kidneys filter out waste and return valuable substances (including glucose) to the bloodstream. But SGLT2 inhibitors block the reabsorption of glucose, causing sugar to be excreted in the urine.

Approval Committee Worried Over Cardiovascular Effects

In January 2013, the FDA assembled a panel of medical experts from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss and vote on Invokana’s approval.

After reviewing safety test data, 8 of the 15-panel members voiced “lingering concerns” regarding cardiovascular health. One clinical trial that had the panel particularly worried suggested that Invokana patients experience a significant increase in “thrombotic events” (blood clotting, heart attacks, and strokes) within the first 30 days of starting a prescription, compared to those taking a placebo.heart-at-risk-from-invokana

Yet, as the heightened risk was seen to fade after 30 days, Janssen Pharmaceuticals dismissed it as “insignificant” and has opted not to mention cardiovascular problems on Invokana’s label—even though a month is long enough to fall victim to a potentially deadly heart attack or stroke.

Though the panel voted 10 to 5 in favor of approving Invokana, even those who voted “yes” considered the lack of long-term safety studies disturbing. Because of this, the FDA granted approval on the condition that Janssen Pharmaceuticals perform 5 extensive post-market studies, including a cardiovascular outcomes trial.

FDA Alerts Patients of Possible Side Effects

In 2015, just 2 years after Invokana’s release, the FDA sent out 2 major safety warnings about Invokana:

FDA Warning #1: Ketoacidosis FDA Warning #2: Bone Problems
Date: May 15, 2015 Sept. 10, 2015
For: Patients on SGLT2 inhibitors Patients on Invokana or Invokamet
Based On: Adverse FDA patient reports Clinical trial results
Threat:
  • Ketoacidosis, a chemical imbalance
  • Common in type 1 diabetes, rare in type 2
  • Usually starts from a lack of insulin/glucose:
    • The body ends up burning fat for energy
    • “Ketones” are produced as byproducts
    • Acidic ketones accumulate
    • Rising acidity affects organ function
    • Can lead to hospitalization or even death
  • All complainants reported hospitalization
  • Increased risk of bone fractures
    • 75 years or older at heightened risk
    • Fractures occurred:
      • Even with minor or no impact
      • Within just 12 weeks
  • Decreased bone mineral density
    • Bone density indicates bone strength
    • Marked loss in the hip and spine
Advice:
  • Patients:
    • Look out for ketoacidosis signs:
      • Difficult breathing
      • Stomach pain
      • Nausea / Confusion
      • Vomiting
      • Fatigue / Sleepiness
  • Doctors:
    • Test patients for ketoacidosis if suspected
    • Halt prescription if illness is confirmed
  • Manufacturer:
    • Revise Invokana / Invokamet labels:
      • Strengthen fracture warning
      • Add section about bone density

Can Invokana Damage The Kidneys?

Recently, a nonprofit organization called the Institute for Safe Medication Practices (ISMP) did an extensive analysis of Invokana patient complaints sent to the FDA and found a high ratio of renal (kidney related) problems.

[gdlr_quote align=”center” ][Adverse renal effects] might be expected from an agent that blocks a normal function of the kidney”  – ISMP researchers on Invokana[/gdlr_quote]

Out of 457 total adverse reports from the second quarter of 2014 alone, the ISMP identified “5 different adverse effects

[that were] directly or indirectly related to the renal toxicity of canagliflozin”:

  • Kidney impairment or failure (54 reports)
  • Fluid imbalances or dehydration (54 reports)
  • Kidney stones (11 reports)
  • Urinary tract infections (50 reports)
  • Unexpected weight loss (52 reports)

In discussing these findings, the ISMP notes disapprovingly that Invokana’s Prescribing Information doesn’t directly warn patients of kidney impairment risks—it only states that patients who already have kidney problems should avoid the medication.

Update February 8, 2016 – Major Label Changes & New Kidney Risk

In May of last year, the FDA began scrutinizing reports on Invokana patients who had suffered from ketoacidosis. Eight months later, the agency’s results are in. Far from exonerating the diabetes drug, FDA reviewers have enforced a mandatory labeling change on all SGLT2 inhibitors. Warning patients and physicians of Invokana’s link to ketoacidosis, the revisions constitute a formal acknowledgment of the drug’s potential to cause this debilitating condition.

Unexpectedly, the FDA added an additional warning to SGLT2 inhibitors, this one about urinary tract infections, in the same stroke. In its official announcement, published December 4, 2015, the agency cautioned the medical community about urinary tract infections that can spread rapidly, infiltrating a patient’s kidneys or blood. FDA experts believe Invokana may increase the risk for these life-threatening infections.

Patients Fighting Back With Lawsuits

Almost immediately after the FDA’s recent labeling changes were made public, several former Invokana patients filed the first lawsuits to hit Janssen Pharmaceuticals in the US.

Currently, US lawsuits have only been brought in relation to ketoacidosis, but in Canada, a patient who suffered kidney failure after taking Invokana recently filed a class action lawsuit.

Kidney Failure After Just 8 Months

Canadian plaintiff Rosalba Joudry, a resident of Scarborough, Ontario, is alleging that Invokana caused her kidneys to fail.  After 8 months of taking her prescription as her doctor instructed, Joudry happened upon a TV commercial about possible Invokana kidney damage, and immediately contacted her doctor.  Diagnostic tests revealed that she was experiencing kidney failure, which can occur with little or no obvious symptoms.  Joudry states that she would never have taken Invokana if she had known about the possibility of kidney damage.

Joudry is holding Janssen Pharmaceuticals liable for her condition because she claims the company:

  1. Failed to ensure that Invokana was safe through “proper design, development, and testing”
  2. Did not provide consumers with a “clear, complete, and current” list of side effect warnings
  3. Should have been aware of Invokana’s possible risks from its kidney-targeted mechanism and from readily-available medical literature on SGLT2 inhibitors
  4. Keeps promoting Invokana as a safe drug while “downplaying the seriousness of potential side effects”

As compensation for suffering that she alleges could have been prevented, Joudry is demanding over $1 billion in damages from Janssen Pharmaceuticals.

Is It Better To File Individually Or Join A Class Action?

Because Joudry and her legal counsel anticipate that many kidney-related Invokana complaints will arise, they are asking for class action certification.  However, due to significant differences between Canadian and U.S. law, a class action may not be the best option for American plaintiffs filing “dangerous drug” lawsuits.

In the U.S., a class action suit:

  • Is filed by a “lead” plaintiff who is meant to represent a number of similar claims
  • Usually automatically includes all qualified claims unless an injured patient explicitly “opts out”
  • Proceeds according to the lead plaintiff’s plans; other “class members” have no say
  • Divides up compensation among all the claimants, with most allotted to the lead plaintiff
  • Typically requires participants to give up their right to file individual claims of their own

According to our experienced legal team, it’s likely far more advantageous for victims of Invokana to file individual suits.  That way, you will have the power to decide how your case proceeds and the full amount of compensation granted will go to you instead of being shared with other claimants.

Overwhelmed? The Product Lawyers Can Help.

Were you or someone you love afflicted with harmful side effects from Invokana or a related drug? You may be able to obtain considerable compensation for your pain, suffering, and loss.

Though filing an Invokana lawsuit may seem intimidating, our experienced, compassionate lawyers can help you every step of the way.  There’s no need to worry about expenses, either—you can start with a free case evaluation, and if your case is viable, we will work for you on a contingency-fee basis.  This means you won’t pay a cent unless we secure a court award or settlement for you.

However, keep in mind that the time period during which you can take legal action is restrained by your state’s statute of limitations. Thus, it’s important to get your case evaluated as soon as possible, to avoid losing your right to file a claim regarding your Invokana prescription.

References

In-Depth Invokana Resources