Invokana Litigation 2017: FDA Alerts Patients To Risk Of Foot & Toe Amputations

Invokana Litigation 2017: FDA Alerts Patients To Risk Of Foot & Toe Amputations 2017-10-16T16:34:16+00:00

New type 2 diabetes drug Invokana has been linked to a host of severe side effects:

  • Toe and foot amputations
  • Diabetic ketoacidosis
  • Kidney failure

At least 900 patients and families have already filed suit against the drug’s manufacturer, Janssen Pharmaceutical. Were you injured while taking Invokana? Our experienced attorneys can help. Contact us today to secure a free consultation and start the legal process today.

Free Invokana Consultation


Our experienced product liability attorneys are ready to stand with Invokana patients who have been forced to undergo an amputation.

Laurence Banville
"Excellent Representation" Laurence was honest with me. Then he exceeded my expectations.
The Legal Herald Reviewed by Jane B. on .
Rating: 5.0 ★★★★★

Invokana, a commonly-prescribed drug for type 2 diabetes, has come under fire for a series of dangerous side effects, including foot and toe amputations and diabetic ketoacidosis. In the wake of multiple warnings from the US Food & Drug Administration, injured patients and families are now filing product liability lawsuits against the drug’s manufacturer, Johnson & Johnson-subsidiary Janssen Pharmaceutical.

Invokana Linked To Lower Limb Amputations

Released on the U.S. market in 2013, Invokana was heralded as a long-awaited innovation in diabetes treatment because its active ingredient comes from a new class of chemicals that lower blood glucose by causing sugar to be excreted in the urine.

But shortly after Invokana’s market debut, the FDA alerted the public to possible evidence linking the drug to several severe side effects, including declining bone health and the development of ketoacidosis, an imbalance in blood chemistry that can prove fatal. New clinical trial data, however, has turned up proof of another significant complication: leg, foot and toe amputations.

Diabetes Finger Prick Test

Free Invokana Case Evaluation

  • This field is for validation purposes and should be left unchanged.

Our Lawyers want to help

Call 888-997-3792

Doubled Risk Of Toe, Midfoot Amputation

As federal researchers wrote in a May 2017 release, the results of two long-term studies have left little doubt that patients taking Invokana undergo lower limb amputations at roughly twice the rate of type 2 diabetes patients taking a placebo.

After reviewing the recent findings, FDA experts concluded that Invokana causes an increase in the risk for amputations, especially amputations of the toe and mid-foot. While patients with diabetes already live at a risk for lower limb amputations, a doubling in that risk, FDA scientists believe, warrants stronger product labeling. The agency took prompt action, ordering Janssen Pharmaceuticals to add a new “black box” warning to Invokana’s prescribing information packet. Today, the product bears this prominent warning:

“Warning: Lower Limb Amputation. In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, Invokana has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg.

Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving Invokana for infections or ulcers of the lower limbs, and discontinue if these occur.”

To many patients, these warnings have only come too late. After suffering serious health problems, from diabetic ketoacidosis to amputation, hundreds of patients have decided to take legal action against Janssen Pharmaceutical.

What Is Invokana?

Invokana is a brand-name pill medication which is:

  • Manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson
  • FDA-approved (since March 29, 2013) for treating type 2 diabetes
  • Intended to help manage blood glucose along with dietary changes and exercise
  • Offered in 100 mg or 300 mg tablets according to patient need

Invokana is also sold in Mexico, Canada, and 41 other countries around the world.

How Does It Differ From Other Diabetes Pills?

pile of Invokana pills or tabletsCanigliflozin, Invokana’s active ingredient, belongs to a recently-developed class of drug molecules—the “gliflozins,” more commonly known as sodium-glucose co-transporter2 (SLGT2) inhibitors.

These molecules act to lower blood sugar by inhibiting a key kidney function.  Normally, the kidneys filter blood waste and save useful substances, such as glucose, for return to the bloodstream.  But SGLT2 inhibitors force the kidneys to include glucose in the urine instead so that it’s purged from the body.

This mechanism of action differs greatly from that of most blood sugar-lowering medications in being completely insulin-independent, which explains much of the hype that surrounded Invokana’s release. SGLT2 inhibitor drugs were anticipated to be more effective for patients who experience limited success on other medication types, or to open up possibilities for hybrid treatment plans combining Invokana and insulin therapy.

More SGLT2 Inhibitor Medicines Follow

After Invokana, the FDA approved additional treatment pills employing SGLT2 inhibitors:

Brand Name Contains SGLT2 Inhibitor Manufacturer(s) Approved
Invokana canagliflozin Janssen Pharmaceuticals March 29, 2013
Invokamet canagliflozin (also contains metformin) Janssen Pharmaceuticals August 8, 2014
Jardiance empagliflozin Boehringer Ingelheim August 1, 2014
Farxiga dapagliflozin Bristol-Meyers Squibb Co. and AstraZeneca January 8, 2014

However, just like its sister drug Farxiga, which was initially denied approval due to possible bladder cancer risks, Invokana had the FDA concerned over potentially dangerous side effects even before it was released.

Possible Cause Of Heart Attacks, Strokes?

During the final FDA approval meeting for Invokana in January 2013, possible cardiovascular effects were brought up as a major cause for concern. An extensive set of presentations supplying drug design details and results from animal studies / clinical trials for Invokana were shown to medical experts from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), to help them decide whether to vote for or against the drug’s approval.

After carefully reviewing the data, 8 of 15 EMDAC panel members declared that they still had “lingering concerns” regarding Invokana’s cardiovascular safety.

Though the panel ended up voting in favor of approving Invokana, one third of the panel members (5 out of 15) did not consider the drug safe enough to be put on the market.  Even most of the members who gave a “yes” vote admitted they were bothered by the lack of long-term clinical studies provided.

FDA Issues Multiple Safety Warnings

Just two years after Invokana’s release, in order to ensure that consumers knew of possible unexpected side effects of the drug, the FDA sent out 2 urgent Safety Communications.

Patients Rushed To The Hospital For Ketoacidosis

In May 2015, the FDA informed the public that patients taking SGLT2 inhibitor medicines like Invokana could be at risk for developing ketoacidosis, a “serious condition of too much acid in the blood” which landed about 20 patients in the emergency room, according to FDA patient reports.

hospital bed for ketoacidosis patientsDoctors were ordered to halt SGLT2 inhibitor prescriptions for any patients found to have ketoacidosis, and patients were advised to look out for potential symptoms of the condition, such as stomach pain, vomiting, strange bouts of fatigue, nausea, and labored breathing.

Why The FDA Needed To Issue A Ketoacidosis Alert

The elevated blood acidity that characterizes ketoacidosis comes from an accumulation of acidic “ketone bodies,” which are byproducts of fat metabolism. Most cases of ketoacidosis occur in patients with type 1 diabetes, because fat metabolizing pathways are triggered by a lack of insulin, a hormone that type 1 diabetics are unable to produce.  Those with type 2 diabetes usually have normal insulin levels and thus rarely suffer from ketoacidosis.

This is why the FDA was so alarmed to see patients on SGLT2 inhibitors (which are only approved for type 2 diabetes) fall victim to the condition—these didn’t seem to be normal instances of ketoacidosis, suggesting they could have been the result of unexplored Invokana side effects, as ketoacidosis risks are not mentioned on the drug’s label.

Clinical Trials Suggest Negative Impact On Bone Health

By September 2015, the FDA already felt compelled to issue another Invokana warning, after reviewing various studies that presented disturbing possible evidence of bone-weakening side effects:

  • Increased Risk of Bone Fractures. In one set of clinical trials focusing on elderly individuals, a group of patients was found to be at a heightened risk of suffering bone fractures in comparison to a placebo group within only 12 weeks of taking Invokana. The study authors also noted with concern that major trauma wasn’t even involved—falls from “no more than standing height” were enough to cause fractures in the affected Invokana patients.
  • Decreased Bone Mineral Density. In studies that monitored patient bone mineral density, a prime indicator of bone strength, researchers discovered that some Invokana patients experienced a marked decrease in density after starting their prescriptions. This decrease occurred to a greater degree in the vulnerable hip and spinal bones.

The FDA had Janssen Pharmaceuticals update Invokana’s label to include these new data and to add / strengthen warnings related to bone health. On the original label, bone mineral density loss was not even mentioned, so the FDA created a new section for that concern.

Should Patients Be Concerned About Kidney Damage?

Some medical experts who had voted against releasing Invokana stated that their lack of confidence in the drug’s safety stemmed from fears about possible adverse renal (kidney-related) effects.  And now, a recently-published analysis of patient complaints to the FDA suggests that such fears may have been well-founded.

The Institute for Safe Medication Practices (ISMP), a nonprofit consumer safety organization, routinely monitors patient reports to the FDA’s “MedWatch” program.  In April-June 2014, the ISMP noticed that Invokana users were reporting an unusually high ratio of “adverse effects directly or indirectly related to the renal toxicity of canagliflozin,” including loss of kidney function and even kidney failure.

The ISMP commented that such negative renal effects “might be expected from an agent that blocks a normal function of the kidney,” and further investigated by looking into SGLT2 inhibitor-related research.

In one particularly troubling set of early clinical trials, kidney function was found to be reduced in Invokana patients within only 6 weeks of starting a prescription. The patients’ “eGFR,” or estimated glomerular filtration rate, a measure typically used to assess kidney disease, were reduced by 4-6%.  Even worse, 4% of patients taking 300mg tablets suffered a considerable (30%) eGFR decline.

When the FDA reviewed these trials, the agency concluded that fluid loss and eGFR reduction that can result from Invokana use “places patients at increased risk for clinically significant episodes of acute kidney injury.”

Has Invokana Been Recalled?

Though potential Invokana side effects had already been brought up by researchers and other experts as problematic, the FDA still allowed Janssen Pharmaceuticals to release the drug, on the condition that the manufacturer conduct more long-term safety studies.

But these studies take several years to complete, and in the meantime, patients throughout the country are taking Invokana, and many of them may be unaware of some of the most dangerous possible side effects of the drug.

While the FDA has issued warnings and requested label changes for Invokana, the agency has not recalled the drug and it may never end up doing so, even if further research shows strong evidence of harm to patients.

Patients Are Turning To Legal Action

Patients who have developed serious ailments after taking Invokana are now seeking justice through filing lawsuits against Janssen Pharmaceuticals.

In Canada, a woman who says Invokana caused her kidneys to fail after only 8 months of her prescription filed a class action lawsuit in September 2015 and expects that many other patients will step forward with kidney-related claims.

By October 2015, at least two U.S. Invokana lawsuits had been filed—one from a woman who developed ketoacidosis in California and another kidney failure lawsuit from a man in Illinois.  Numerous other claims are currently under investigation, and the legal community anticipates that many more cases will be filed in the near future.

Did Janssen Fail To Safeguard Consumers?

In these lawsuits, the plaintiffs claim that Janssen Pharmaceuticals failed to ensure that Invokana was safe for patient use, pointing out a host of alleged failures in safely designing, properly testing, and accurately labeling the drug with a comprehensive list of side effect warnings.

According to the plaintiffs, Janssen Pharmaceuticals should have known about Invokana’s potential risks, based on publicly available medical research and basic facts about its active ingredient’s drug class. Thus, the lawsuits state, the considerable suffering, damage to health, and financial loss that the plaintiffs endured could have been prevented if the manufacturer had taken reasonable measures to protect consumers.

How Can I File A Lawsuit?

If you or a loved one experienced harmful side effects from a prescription of Invokana or a related drug, you may be able to file a claim and obtain rightful compensation for the hardships you’ve endured.

The best way to find out if you have a valid claim is to speak with an experienced attorney.  Banville Law is now offering free case evaluations to injured Invokana patients. Contact our firm today to start exploring your legal options at no cost.

Free Invokana Case Evaluation

  • This field is for validation purposes and should be left unchanged.

Breaking Legal News