What is Invokana?
Invokana (Canagliflozin) is a medication designed to treat type 2 diabetes. The drug was originally approved for general use by the Food and Drug Administration in 2013, making it the first commercially available SGLT2 inhibitor in the United States.
SGLT2 inhibitor type drugs, including Invokana, work by blocking key transporter proteins in the body which allows up to 119 grams of blood glucose a day to be eliminated through urine. Since the drugs approval, Invokana has received a host of negative attention from the FDA, as well as in the media. The Food and Drug Administration has required several label updates for the drug, detailing increased risk of leg and foot amputation as well as a detailed link to diabetic ketoacidosis (DKA).
In May of 2017, the FDA announced that it would require Johnson & Johnson to label Invokana with a “black box warning” (the most serious) indicating the potential for toe, foot, and leg amputations. This type of warning issued by the FDA, requires the drug manufacturer to list the possibility of serious or life-threatening complications on the drug’s physical packaging, as well as on all marketing material.
More specifically, the FDA mandated black box warning reads:
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.
This announcement comes after two clinical studies, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (a study of the effects of Canagliflozin on renal endpoints in adult participants with type 2 diabetes mellitus) showed a 78% increase in risk of amputation compared to patients taking placebo drugs. Since Invokana was approved in 2013 (four years before the black box warning was issued), many patients have filed suit against Johnson & Johnson, claiming the manufacturer willingly sold them a defective medication.
Invokana Diabetic Ketoacidosis
Invokana has been linked to serious, sometimes fatal, occurrences of diabetic ketoacidosis (DKA); a condition that causes excessive acid buildup in the blood. The main cause of DKA is a lack of insulin in the blood. This produces a chain reaction in which the body burns fat cells instead of sugar for energy. The process produces acids called ketones that can eventually build up to dangerous levels in the body.
Symptoms of DKA include:
- Nausea or vomiting
- Pain in the abdomen
- Excessive thirst
- Loss of appetite
- Mouth dryness
- Sweet or fruity scented breath
- Excessive or frequent urination
- Blurred vision
- Mental confusion
- Weight loss
- Rapid breathing or shortness of breath
If you or a loved one has experienced any of these symptoms, contact your health care provider immediately.
Invokana Side Effects
Invokana has only been on the market for less than half a decade, yet the drug has been linked to hundreds of deaths. In such a short timeframe, there have already been four separate FDA announcements linked to adverse effects associated with the drug used to treat diabetes.
Common side effects of Invokana include:
- Urinary tract infections
- Increased urination
- Yeast infections
- Vaginal itching
- Skin sensitivity to sunlight
- Hypersensitivity reactions (including skin redness, rash, itching, hives, and swelling)
Adverse listed side effects of Invokana include (as of July 2017):
- Acute kidney injury and Impairment in renal function
- Urosepsis and pyelonephritis
- Hypoglycemia with concomitant use with insulin
- Genital mycotic infections
- Hypersensitivity reactions
- Bone fracture
- Increases in low-density lipoprotein (LDL-C)
If you experience any of these symptoms, contact your doctor or emergency services immediately.
Hundreds of patients have opted to file suit against Invokana’s manufacturer, Johnson & Johnson, claiming that numerous, unlisted and adverse conditions associated with the drug have negatively affected their way of life. Many of these suits claim that the multi-billion dollar manufacturer intentionally withheld information that could have prevented patients from developing Diabetic ketoacidosis (DKA) and others from losing their limbs at the hands of what they call a “faulty drug”.
Invokana In The News
Forbes.com recently reported on Invokana’s latest hit, as the FDA announced the drug can cause an increased risk of leg and foot amputation. The article forecasted a loss in Johnson & Johnson market share for diabetes medication. While this may be bad news for investors, it is being heralded as progress by those injured by Invokana.
Reuters Online focused on the FDA warning about potential amputations by saying, “The FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo. A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.” These independent studies resulted in an over 110% increase in the first study and a 78% increase in risk according to the second study.
Invokana & J&J In Summary
Hundreds of men and women have filed suit against drug giant Johnson & Johnson after suffering devastating side effects at the hands of diabetes medication Invokana. Since the drug’s approval, Invokana has received a host of negative attention from the FDA as well as in the media. The Food and Drug Administration has required several label updates for the drug, detailing the increased risk of leg and foot amputation as well as a detailed link to Diabetic ketoacidosis (DKA). This announcement comes after two clinical studies, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (a study of the effects of Canagliflozin on renal endpoints in adult participants with type 2 diabetes mellitus) showed a 78% and 110% increase in risk of limb amputation compared to patients taking placebo drugs. Johnson & Johnson is currently valued at over $65 Billion USD.