Truth: The FDA has announced 6 different warnings for invokana, invokamet, invokamet XR, and other SGLT2 inhibitors.
Truth: Invokana is already facing a class-action lawsuit in Canada for kidney failure and a Multi-District Litigation case in the state of New Jersey.
Truth: Janssen Pharmaceuticals, owned by Johnson & Johnson, is already attempting to pass a supplemental drug for patients to take in conjunction with invokana, called NDA for invokana.
The FDA is aware of continued problems with invokana, invokamet, and invokamet XR. Instead of improving or voluntarily recalling the already-questionable drug, the manufacturer is producing yet another medication to sell for prescribing with invokana. This is based on the results from the ongoing CANVAS studies.
This is what happens when business is placed before your health. Don’t let these companies take advantage of you. Take action now.
What Is Invokana?
Invokana is a pill taken once per day, prescribed to adults for treatment of type 2 diabetes. It can’t be used for treatment of type 1 diabetes or for patients experiencing diabetic ketoacidosis. Invokana also isn’t approved for use in patients under the age of 18.
As of May 2017, the Food and Drug Administration (FDA) implemented a black box warning for invokana, requiring new labels for the medication. The black box warning was assigned due to an increased risk of foot and leg amputations, as identified in two large clinical trials at the time.
What’s the Difference between Invokana, Invokamet, & Invokamet XR?
Invokana, invokamet, and invokamet XR are all similar medications, manufactured by Janssen Pharmaceuticals, which is owned by Johnson & Johnson.
Invokana’s active ingredient is canagliflozin. Invokamet is a combination of canagliflozin plus metformin hydrochloride (also called glucophage). There is a third version of this medication as well, meant for extended-release uses, called invokamet XR. Invokamet XR is the same active ingredient of canagliflozin, but the metformin hydrochloride is an extended-release form, also known as glumetza.
The FDA’s black box warning in 2017 applied to all three medications.
How Does Invokana Work?
Invokana the first SGLT2 inhibitor in the United States. An SGLT2 inhibitor is a newer class of medication that works by reducing A1C in adult patients with type 2 diabetes.
|What Is an SGLT2 Inhibitor?||What Is the A1C Test or an A1C Level?|
|This stands for a class of drugs called “subtype 2 sodium-glucose transport” inhibitors or “sodium-glucose cotransporter-2” inhibitors. They lower A1C levels in adult patients who have type 2 diabetes.||This is a test used to diagnose and manage diabetes. It measures a percentage of how much of your hemoglobin (a protein that carries oxygen in red blood cells) is covered by sugar, or “glycated.”|
According to the Mayo Clinic, an A1C level of 5.7 to 6.4 percent is considered prediabetes. Most patients who have already been diagnosed with diabetes aim for an A1C level of 7 percent or less.
A patient’s A1C level indicates his or her average blood sugar level during the previous several months or year, depending on the frequency of taking the A1C test. Below is a table which explains the related blood sugar levels based on A1C level.
|A1C Level||Average Blood Sugar Level (approximate)|
|5 percent||97 mg/dL (5.4 mmol/L)|
|6 percent||126 mg/dL (7 mmol/L)|
|7 percent||154 mg/dL (8.5 mmol/L)|
|8 percent||183 mg/dL (10.2 mmol/L)|
|9 percent||212 mg/dL (11.8 mmol/L)|
|10 percent||240 mg/dL (13.3 mmol/L)|
|11 percent||269 mg/dL (14.9 mmol/L)|
|12 percent||298 mg/dL (16.5 mmol/L)|
|13 percent||326 mg/dL (18.1 mmol/L)|
|14 percent||355 mg/dL (19.7 mmol/L)|
How Do I Know Whether I Can Take Invokana or Invokamet?
Patients who meet any of the following criteria shouldn’t take invokana:
- Are experiencing diabetic ketoacidosis
- Are under the age of 18
- Have type 1 diabetes (instead of type 2)
- Have significant kidney problems
- Are on dialysis
- Are allergic to canagliflozin
- Are allergic to metformin hydrochloride (invokamet or invokamet XR only)
- Are breastfeeding (patients who may become pregnant or are already pregnant should speak with their doctor prior to taking invokana or invokamet, as these medications could injure the baby)
There are many other contraindications that may increase risks associated with invokana or invokamet. Labels inform patients to talk with their doctor if they are over 65 or have any of the following:
|Heart disease, or at risk of heart disease||Problems with urination||Liver problems|
|Congestive heart failure||On a low-sodium diet||Frequent consumption of alcohol|
|History of urinary tract infections||About to get an injection of dye or contrast agent for MRI, such as gadolinium||Problems with pancreas|
|On a very low-calorie diet or eating less due to illness||Have a history of amputation||Have any form of kidney problems|
Interaction with Other Medications
Other prescription medications may increase risks while taking invokana. The updated labels inform patients to alert their doctor if they’re taking any of the following:
- Diuretics, or water pills
- Rifampin, which is used for treatment of tuberculosis
- Phenobarbital or phenytoin, a medication used for managing seizures
- Ritonavir, which also goes by Norvir or Koletra and is used to manage HIV
- Digoxin, also called Lanoxin and is used for treating heart problems
What Are the Risks of Taking Invokana?
Invokana comes with a long list of possible side effects. Depending on the issue and how it escalates, some of these side effects can be life threatening. In addition, loss of limbs can lead to a significant reduction in quality of life for the patient.
If you’ve received an amputation while taking invokana, invokamet, or invokamet XR - don’t delay in getting help. There is only so much time you can take to seek compensation. Contact our experienced team of attorneys today for a free consultation. There’s no cost to you unless we win in settlement or in court.
Major Invokana Risks & Their Warning Signs
Increased Risk of Amputation
As of May 2017, the FDA announced a black box warning for invokana due to nearly double the risk of lower limb amputations. This followed an earlier announcement in May 2016 that results of an ongoing study named CANVAS had shown likelihood of increased risk for amputation while taking invokana.
The two studies involved were called CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study on the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus). As studies have continued, this may also be referred to as the CANVAS Program, with specific phases referenced. The table below shows the results of the published CANVAS and CANVAS-R studies.
|CANVAS Study (over the course of 1 year)||CANVAS-R Study (over the course of 1 year)|
|Risk of amputation was 5.9 out of every 1000 patients taking canagliflozin||Risk of amputation was 7.5 out of every 1000 patients using canagliflozin|
|Risk of amputation was 2.8 out of every 1000 patients taking the placebo||Risk of amputation was 4.2 out of every 1000 patients taking the placebo|
The most common amputations were toes, up to the middle of the foot. However, some patients lost their legs above or below the knee, and amputations on each leg. This significantly impacts the quality of life for patients. If you had one or more amputations done while taking invokana, reach out to us today. Our help is always free unless you benefit first.
If you’re taking invokana, invokamet, or invokamet XR and develop new ulcers, sores, infection, pain or tenderness in your lower limbs, speak with your doctor right away.
Specifically, lactic acidosis is a risk of invokamet and invokamet XR only. This is a serious condition where the metformin hydrochloride causes lactic acid to build up in the patient’s bloodstream. Although rare, this condition is life-threatening and requires hospitalization for treatment.
Warning signs of lactic acidosis include suddenly feeling very weak or tired, unusual muscle pains, stomach pains, nausea, vomiting, feeling lightheaded or dizzy, sleeping excessively, trouble breathing, cold hands or feet, and a slow or irregular heartbeat.
Lactic acidosis is a medical emergency. If you’re experiencing these symptoms, contact your doctor right away.
Fournier’s gangrene is the more common term for the medical condition called necrotizing fasciitis of the perineum. This condition is a life-threatening bacterial condition. Although it is rare, patients with diabetes seem to be at slightly higher risk of developing Fournier’s gangrene, and diabetes patients taking SGLT2 inhibitors are at a significantly higher risk.
Between March 2013 and May 2018, the FDA identified 12 cases of Fournier’s gangrene among patients taking SGLT2 inhibitors. Seven of the patients were male and five were female. All of the patients required surgery and hospitalization. One of the patients died, while several others required follow-up surgeries that were disfiguring.
In comparison, only 6 cases of Fournier’s gangrene were found in the last 30 years among diabetes patients taking other classes of medication. All non-SGLT2 inhibitor cases were male.
Symptoms of Fournier’s gangrene include redness, tenderness, or swelling anywhere from the genitals to the area behind the rectum. There is usually a fever developing of 100.4 F or higher, and patients generally feel unwell.
If you’re experiencing these symptoms, seek medical help immediately as this condition can be fatal.
Invokana is just one type of SGLT2 inhibitor. For more information on this class of diabetes medication, visit our SGLT2 inhibitors page.
Ketones are a chemical made in the liver when the body doesn’t have enough insulin to convert glucose (the body’s preferred fuel source) into energy. So the body burns fat instead.
When the ketones in your blood or urine increase significantly, this is called ketoacidosis. This can happen for many reasons, including untreated type 1 diabetes.
In December 2015, the FDA provided warnings of increased risk of ketoacidosis while taking SGLT2 inhibitors in general. This pertains to invokana, invokamet, invokamet XR, and several other medications in the SGLT2 inhibitor class.
Some patients experience diabetic ketoacidosis while taking invokana. This is a life-threatening condition which can require hospitalization. Warning signs of ketoacidosis include nausea or vomiting, stomach pains, tiredness, or even trouble breathing. If you’re taking invokana, invokamet, or invokamet XR and experiencing these symptoms, seek medical help right away.
Ketoacidosis-Induced Heart Attack
A secondary result of untreated diabetic ketoacidosis while taking invokana may heart attack. As the blood becomes more acidic during ketoacidosis, stress is placed on all organs in the body. The risk of heart attack and major adverse cardiovascular events (MACE) increases.
Although bone fractures were cited as an adverse reaction on the original invokana label, the FDA advised stronger warnings of fractures in September 2015. The FDA cited that fractures can occur as early as 12 weeks into treatment with invokana, invokamet, or invokamet XR.
In addition, this warning informed the public of an decreased bone mineral density risk, particularly at the hip and lower spine.
These updates required another set of new labels for invokana.
Acute Kidney Injury
Sudden kidney injuries have happened while patients are taking invokana, invokamet, or invokamet XR. These are urgent complications, and patients are informed to speak with their doctor right away if they’ve reduced the amount they’re eating or drinking for any reason. Patients taking invokana should also seek medical attention right away if they experience a sudden loss of fluids, such as long sun exposure, vomiting, or diarrhea.
In June 2016, the FDA strengthened warnings of acute kidney injury to patients taking invokana (canagliflozin) or a similar medication called dapagliflozin. This was based on research conducted between May 2013 and October 2015, with 101 cases reported via the FDA’s Adverse Event Reporting System (FAERS).
Approximately half of the cases of acute kidney injury occurred within the first month of taking invokana and improved after taking the patient off invokana. Many patients had to be hospitalized for treatment and some received dialysis.
Although kidney problems can escalate quickly while taking invokana, some warning signs may include itching, nausea, vomiting, weakness, loss of appetite, or fatigue.
Some patients wind up losing too much water while taking invokana. This can happen gradually, over time or may come on suddenly. Symptoms that you’re dehydrated include feeling dizzy, faint, weak, or lightheaded.
Patients who have low blood pressure or are taking medication for blood pressure might be at higher risk of dehydration. Ironically, the manufacturer of invokana touts that their medication may also help in lowering blood pressure.
If patients become too dehydrated, hospitalization and IV treatment may be necessary. Dehydration can be especially dangerous for older adults taking invokana, and dehydration that goes untreated can be fatal.
Hyperkalemia occurs when there’s too much potassium in the bloodstream. Potassium is important for the use in nerve cells and muscle cells, which can impact how the heart is beating. Normal blood potassium levels are considered to be between 3.6 and 5.2 mmol/L.
If blood potassium levels are over 6.0 mmol/L, immediate medical attention is required.
Warning signs of hyperkalemia include heart palpitations, numbness, tingling, weakness, exhaustion, trouble breathing, nausea, vomiting, or even chest pains. If left untreated, paralysis or heart arrhythmias can occur.
Severe Urinary Tract Infections
While urinary tract infections (UTI) can be relatively common in healthy individuals and easy to treat, if they are allowed to progress this type of infection can become life-threatening. Patients are told to speak with their doctors right away if they experience pain in the lower part of the abdomen, burning during urination, a strong and frequent urge to urinate, or blood in the urine. Some UTIs may also show symptoms of back pain, nausea, vomiting, or a high fever.
In December 2015, the FDA cited increased risk for severe urinary tract infections in patients taking any form of SGLT2 inhibitors. This include invokana, invokamet, invokamet XR, and other SGLT2 inhibitors.
Hypoglycemia is the medical term for low blood sugar. There are many warning signs of hypoglycemia, including irritability, shakiness or anxiety, fatigue, hunger, pale skin, sweating, a tingling feeling near the mouth, an irregular heartbeat, feeling jittery, and sudden outbursts during sleep.
Some particularly advanced symptoms of hypoglycemia include blurred vision, confusion, seizures, and loss of consciousness.
Patients who may be taking other blood sugar medications are at higher risk of this complication. In particular, doses of insulin or sulfonylurea may need to be discussed with a doctor and adjusted or reduced.
More Research Required: Increased Risk of Breast and Bladder Cancer
There have been concerns with SGLT2 inhibitor class drugs and various forms of cancer. It is cited that the spreading of lung cancer is linked to higher expression of the SGLT gene itself. However, as SGLT2 inhibitors, this isn’t an immediate concern.
What is more concerning is a possible increased risk in breast cancer for women and bladder cancer for men. While animal-based studies didn’t indicate an increased breast or bladder cancer risk, preclinical trials of SGLT2 inhibitors did show an increase in female breast cancer and male bladder cancer.
These increases were considered statistically non-significant in these preclinical trials. Furthermore, there was question of whether the increased risk of UTIs led to more frequent urinalysis, which led to more immediate detection of bladder cancer if identified.
The ultimate conclusion is that patients deserve more research to be conducted, regarding the effect of SGLT2 inhibitors on breast cancer in women and bladder cancer in men.
Other Side Effects of Invokana
Invokana presents a variety of other side effects that are typically easier to treat, including:
- Male or female genital yeast infection
- Allergic reactions
- Vitamin B12 deficiency
FDA Extends Timeline for Review of New Invokana Supplemental Drug
While there are already many risks with taking invokana, invokamet, and invokamet XR, Janssen Pharmaceuticals is progressing with developing new drugs specifically for supplementing their existing set of SGLT2 inhibitors.
The new supplemental medication is called sNDA for invokana. Janssen Pharmaceuticals claims this new drug will help reduce the risk of major adverse cardiovascular events, when taken with fixed-dose combinations of invokana, invokamet, or invokamet XR.
Janssen Pharmaceuticals states this new drug is being developed based on data provided by Phase 3 of the CANVAS studies mentioned above. As of July 2018, the FDA requested an additional 3 months to review this new supplemental medication.
Invokana is already facing a class-action lawsuit in Canada, alleging that the drug can cause kidney failure.
In the United States, individual invokana lawsuits continue to pile up. Prosecutors are claiming that the manufacturer knew more about the severe side effects than was initially provided to the public. The number of federal invokana cases has increased enough to escalate to a Multi-District Litigation (MDL) case in the state of New Jersey, where Johnson & Johnson is located.
How Do I Know if I Have A Case?
If you experienced any of the following while taking invokana, invokamet, or invokamet XR, you may have a case:
- Stroke or heart attack
- Diabetic ketoacidosis
- Lactic acidosis
- Fournier’s gangrene
- Kidney injuries
- Bladder cancer
- Breast cancer
You and your family have suffered enough. You may be able to receive compensation for lost wages, medical treatments, pain and suffering.
There are statutes of limitations that designate how much time you have to seek legal action for a crime. Don’t put off speaking with an attorney. It’s free, and if we take your case we’re only compensated if we win.
Our legal team is experienced in complex medical litigation cases. Contact us today to get the representation you and your loved ones deserve.