Invokana (canagliflozin) is a diabetes drug that prevents the kidneys from reabsorbing glucose, allowing blood sugar to be expelled in the urine. It was approved by the U.S. Food and Drug Administration (FDA) in 2013 as the first of a new class of diabetes medicines called sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors).
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What Consumers Should Know About Invokana
In recent years, Invokana has been associated with a number of possible side effects. Among these are a higher risk of lower-limb amputations, development of a flesh-eating bacteria on the genitals called Fournier’s gangrene, diabetic ketoacidosis, and kidney disease. As a result of these complications, thousands of people have filed lawsuits against Janssen Pharmaceuticals and Johnson & Johnson.
There have been some medical studies suggesting that Invokana can have positive effects aside from helping to reduce blood sugar, such as reducing the risk of heart disease and helping patients lose weight. However, these uses are not approved by the FDA, and it is unclear whether these benefits outweigh the more dangerous side effects associated with canagliflozin.
How Invokana Works
Like other SGLT2 inhibitors, Invokana works by blocking the sodium-glucose co-transporter 2 protein. Normally, this protein allows the kidneys to reabsorb glucose and return it to the bloodstream. However, by turning off the protein, canagliflozin – the active ingredient in Invokana – causes the kidneys to remove sugar from the body and excrete it through the urine.
It is important to know that Invokana is only approved for use with a doctor-approved diet and exercise. It is not intended to be a standalone treatment for diabetes. It may also be combined with other medications – for example, Invokamet is a combination of canagliflozin and metformin (Glucophage), another diabetes drug that helps reduce the production of glucose in the liver.
Who Should Avoid Invokana
While Invokana is approved for use by many people who have type 2 diabetes mellitus, some people may be more at risk of developing serious side effects than others.
Expectant and New Mothers: Because Invokana could impair kidney development in fetuses and infants up to age 2, women who are nursing or pregnant (especially in the second or third trimester) should avoid using Invokana. It is not recommended for use to treat gestational diabetes. If you become pregnant while taking Invokana, you should talk to your health care provider right away to discuss alternative treatments.
Children Under 18: There have been no reliable studies or clinical trials of Invokana in pediatric patients. Since the long-term effects of canagliflozin on children are still unknown, patients under the age of 18 should take Invokana.
Elderly Patients: Because older patients have reduced intravascular volume, they may be more susceptible to adverse reactions than younger patients. Clinical trials have shown that Individuals age 65 years and older have a higher occurrence of damaging side effects than those under age 65. The risk went up significantly in patients age 75 and older.
Individuals with Kidney Disease: Patients with even mild or moderate renal impairment (kidney disease) could be at a higher risk of suffering from severe complications, including life-threatening kidney problems, when taking Invokana. Invokana is not recommended for patients who receive dialysis.
People Who Are Allergic: Some people could be allergic to canagliflozin or one of Invokana’s non-active ingredients. Allergic reactions can include rash, hives, or swelling of the face, lips, tongue, or throat, which could lead to trouble breathing or swallowing.
Invokana Inactive Ingredients
- Croscarmellose sodium
- Hydroxypropyl cellulose
- Lactose anhydrous
- Magnesium stearate
- Microcrystalline cellulose
- Iron oxide yellow E172
- Polyvinyl alcohol
- Titanium dioxide
Who Makes Invokana?
Invokana was developed and marketed by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. Janssen makes three drugs containing canagliflozin, the active ingredient in the drug.
- Invokana – contains canagliflozin
- Invokamet – contains canagliflozin and metformin hydrochloride
- Invokamet XR – contains canagliflozin and metformin hydrochloride in an “extended release” formula meant to allow once-per-day dosage
Invokana Side Effects and Complications
Canagliflozin has been associated with a number of extremely dangerous, and possibly even fatal, side effects.
Fournier’s gangrene is a form of flesh-eating bacteria (necrotizing fasciitis) that attacks the genitals and surrounding area, known as the perineum. This potentially life-threatening bacterial infection is extremely rare, but a review of cases over a 5-year period from March 2013 to May 2018 showed a significantly higher number of Fournier’s gangrene cases in patients who take Invokana and other SGLT2 inhibitors than in those who took other diabetes drugs. All 12 of the patients who developed Fournier’s gangrene required surgery, several of which caused further complications and permanent disfigurement, and one patient died.
Diabetes carries an inherent risk of lower-limb amputation, most often of one or more toes but also occasionally for a foot or lower leg. Individuals who take Invokana, however, have nearly double the risk of a toe, foot, or lower-leg amputation than diabetes patients who do not take Invokana. According to the two biggest clinical trials of Invokana to date, known as CANVAS and CANVAS-R, people who take invokana have between a 0.59% and 0.75% chance of requiring a lower-limb amputation. Most of these amputations were necessary due to other complications arising from vascular problems, such as infection, gangrene, or diabetic foot ulcers.
Diabetic ketoacidosis is a severe complication that occurs when high levels of blood acids (ketones) accumulate in the blood. Individuals who develop ketoacidosis typically require immediate hospitalization for treatment and monitoring. If left untreated, ketoacidosis can cause dehydration, brain swelling (encephalopathy), coma, and even death. Common symptoms of ketoacidosis include abdominal pain, difficulty breathing, fatigue, fruit-smelling breath, nausea, and vomiting.
Other Severe Invokana Side Effects
The following dangerous side effects are somewhat rare, but could also be experienced by Invokana patients.
Renal Impairment: Invokana has been linked to a lower estimated glomerular filtration rate (eGFR), which is a measure of kidney function. Patients with low blood volume (hypovolemia) have a higher risk of this condition, and increased monitoring of kidney function is recommended while taking Invokana.
Blood Infections: Urinary tract infections (a common minor side effect) can turn into dangerous blood infections (urosepsis) in patients taking Invokana. From March 2013 to October 2014, the FDA identified nearly 20 cases of kidney infections and blood infections.
Acute Pancreatitis: A rare but serious Invokana side effect is the sudden inflammation of the pancreas, the body’s insulin-producing organ. Some researchers believe acute pancreatitis can arise due to Invokana’s dehydrating (diuretic) effects.
Common Invokana Side Effects
- Abdominal pain
- Bone fractures
- Candida balanitis (men)
- Cholesterol increase (dyslipidemia)
- Dyspnea (trouble breathing)
- Hives (urticaria)
- High hemoglobin count
- Hyperkalemia (high potassium)
- Hypermagnesemia (high magnesium)
- Increased urination
- Itching (pruritis)
- Loss of strength/energy
- Low blood pressure (hypotension)
- Low blood sugar (hypoglycemia)
- Redness of the skin (erythema)
- Swelling (angiodema)
- Urinary tract infections
- Yeast infection (women)
FDA Actions Involving Invokana
Since Invokana’s initial approval in 2013, the FDA has issued a series of warnings and safety information about the dangers of taking Invokana.
August 2018 – Initial warning about the risk of potentially deadly bacterial infections of the genitalia (Fournier’s gangrene, necrotizing fasciitis) when taking SGLT2 inhibitors, including canagliflozin-based drugs.
March 2017 – FDA confirmed the increased risk of lower-limb amputations when taking medications containing canagliflozin (Invokana, Invokamet, and Invokamet XR), requiring a new boxed warning on the drug’s label.
June 2016 – The FDA required pharmaceutical companies to strengthen warnings about the risk of kidney damage on drug labels for Invokana/Invokamet (canagliflozin) and Farxiga/Xigduo XR (dapagliflozin).
May 2016 – Initial results from ongoing clinical trials are published indicating the potential for an increased risk of lower-body amputations when taking Invokana.
December 2015 – Drug labels for all SGLT2 inhibitors, including Invokana, require updates to inform the public about the increased risk of ketoacidosis and urinary tract infections.
September 2015 – The FDA requires Janssen to update Invokana’s drug label to include information about the risk of broken bones and decreased bone mineral density.
Thousands of people have filed Invokana lawsuits against Janssen due to side effects suffered by themselves or their loved ones. Most of these lawsuits focus on extreme and potentially deadly complications, such as Fournier’s gangrene, amputation, and ketoacidosis.
If you or a loved one has experienced Invokana’s adverse effects, you could be eligible for compensation to pay for treatments, physical therapy, follow-up appointments, and other expenses. Connect with an Invokana lawyer today to get a free case review and learn about your legal rights.
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