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The Story Behind the FDA Warnings

The makers of Invokana tout the drug as a miracle breakthrough for adults with type 2 diabetes. Yet everyday patients and the U.S. Food and Drug Administration tell a very different story.

Warnings of the Side Effects

Warnings of acute kidney injuries, amputations, heart attacks, and other severe side effects have surfaced as patients and their health care providers increasingly report dangerous injuries from the drug. Now, lawsuits are emerging that accuse the drug’s manufacturer of failing to warn patients of the devastating side effects of Invokana.

If you or someone you love has suffered as a result of taking this dangerous medication, you may have a right to pursue compensation. Learn More.

Have You Experienced Severe Side Effects from Invokana?

Invokana, also known as canagliflozin, is supposed to help type 2 diabetes patients manage their blood sugar by blocking reabsorption of glucose by the kidneys and allowing the release of excess sugar through urination. It was approved by the FDA in March 2013 as the first SGLT2 inhibitor to be used in the United States. Since then, increasingly serious side effects have emerged at the expense of patients’ health.

  • Diabetic ketoacidosis, which causes vomiting, difficulty breathing, nausea, abdominal pain, confusion, and excessive fatigue
  • Dizziness or lightheadedness
  • Extreme dry mouth and increased thirst
  • Frequent urination, serious bladder infections, urinary tract infections, and pain
  • Vaginal yeast infections and male genital mycotic infections
  • Pain during sex
  • Muscle weakness and irregular heartbeat due to dangerously high potassium levels
  • Trouble breathing and tightness in the chest
  • Swelling of the mouth, lips, face, throat, and tongue
  • Voice hoarseness, pain, and irritation
  • Rash and itching
  • Weight gain
  • Loss of appetite
  • Anxiety or depression
  • Pale skin
  • Headache
  • Seizures
  • Slurred speech
  • Hypoglycemia
Side Effects On Body

Prevalence of Diabetic Ketoacidosis Reported by Invokana Users

Top 10 Drugs That Report Diabetic Ketoacidosis as a Side Effect

New Concerns About High Levels of Blood Acid

Now, only two years after its approval, the FDA has issued a warning that Invokana could cause dangerously high levels of blood acids in some patients. The agency issued the warning in May 2015, citing 20 cases of diabetic ketoacidosis, a condition caused by the body producing abnormally high levels of blood acids known as ketones. The warning stated that the FDA identified at least 20 incidents of acidosis in people taking this drug and two similar medications, Farxiga and Jardiance, between March 2013 and June 2014. The cases of acidosis involved emergency room visits or hospitalization. The information was collected by the FDA’s Adverse Event Reporting System (FAERS) database, which is designed to support post-marketing safety programs. The reports are provided on a voluntary basis by healthcare professionals and consumers either directly to the FDA or to the manufacturers of the drug. Manufacturers who receive reports are required to send them to the FDA. (Invokana)

Quotation Mark

"I had excessive bleeding, horrifying and painful kidney infections, chronic constipation, hair loss, incontinence, golf ball size clots in my urine, and I am still peeing blood after stopping it 3 weeks ago, my legs and hands swelled, my numbers are rising in the morning from 110 and now at 140-180...

Living like [this] is not worth it."

When Did the Warnings About Invokana Start?

The Food and Drug Administration approves canagliflozin, marketed as Invokana, for use in the United States.

March 2013

The FDA warns that people using Invokana should not use urine glucose tests to monitor glycemic control because SGLT2 inhibitors increase glucose excretion through the urine, leading to positive tests.

May 2014

The FDA reports that a small portion of people stopped taking the drug after suffering from genital mycotic infections (or fungal infections).

March 2015

The FDA warns that canagliflozin, dapagliflozin, and empagliflozin (all type 2 diabetes drugs) may cause ketoacidosis, a serious condition in which the body produces high levels of blood acids, known as ketones. The FDA notes that the condition may require hospitalization.

May 2015

The FDA indicates that people taking Invokana are at a greater risk for falls that can cause bone fractures.

September 2015

The FDA indicates that it has received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, due to the use of canagliflozin or dapagliflozin. The administration warns that there are likely additional cases that haven’t been reported.

October 2015

The FDA indicates that hypersensitivity reactions, such as angioedema and anaphylaxis, have been reported with Invokana.

March 2016

The FDA reports that Invokana causes intravascular volume contraction and can cause renal impairment. It also alerts the public that an ongoing clinical trial indicates that patients taking canagliflozin were at increased risk of leg and foot amputations, mostly affecting the toes.

May 2016

The FDA strengthens its kidney warnings for canagliflozin and dapagliflozin.

June 2016
Quotation Mark

"My brother was prescribed Invokana … and developed a cancerous tumor in his kidney. It was a very complicated surgery because of where the tumor was located, and because of that, the entire kidney had to be removed. He was taking 300 mg. Upon diagnosis, the surgeons instructed my brother to stop the medication immediately. My brother never had any kidney problems in his whole life.

Let this be a warning.”

Question Mark

Has Invokana Been Recalled?

Unfortunately, no. Diabetes patients who are prescribed the drug continue to be at risk of experiencing these life-threatening side effects.

Even with increasingly serious warnings of kidney problems from the FDA, the drug’s maker, Johnson & Johnson’s Janssen subsidiary, has continued to market Invokana.

In fact, the company still touts on its website that “INVOKANA® works with your kidneys to help you lose some sugar through the process of urination.” Meanwhile, it has tacked on a long list of serious side effects underneath the claim ─ warnings of kidney problems, urinary tract infections, yeast infections, hypoglycemia, ketoacidosis, and broken bones.

Are Other Drugs Like Invokana Dangerous?

Invokana (canagliflozin) was touted as a groundbreaking drug because it was the first sodium-glucose co-transporter 2 (SGLT2) inhibitor introduced in the United States. SGLT2 inhibitors block the reabsorption of glucose (or blood sugar) by the kidneys and increase glucose excretion in a person’s urine.

Other medications in the SGLT2 category include:

  • Invokamet, which contains canagliflozin and metformin
  • Jardiance, or empagliflozin
  • Glyxambi, which contains empagliflozin and linagliptin
  • Farxiga, or dapagliflozin
  • Xigduo XR, which contains dapagliflozin and metformin

The FDA warnings about Invokana have also included these SGLT2 inhibitors, calling into questions their safety as well.

Quotation Mark

I’ve been on Invokana for two years. … However, I had to stop taking it today after I put two and two together [on] the symptoms I am having. Hair loss; severe muscle and joint pain; severe muscle cramps and contractions of legs at night that I would literally cry, and hands cramping and contracting day and night; frequency and urgency to urinate (I unknowingly pee'd in bed several times and pee on myself during the day uncontrollably); brain fog, severe tiredness; constant yeast infection; bladder infections; constant thirst; and eye infections when I never ever had them before.

How Can I Learn More?

Invokana is a widely discussed topic among many outlets online. Educating ourselves from multiple sources can lead to the discovery of new information and data that might not be found by visiting one resource. Expand upon your knowledge, and view trending blog posts, articles, and outside resources below that can help you to become a more informed individual.

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