Amputation After Taking Invokana?

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National Invokana Injury Lawsuits

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Invokana (canagliflozin), Invokamet (canagliflozin and metformin), and Invokamet XR (canagliflozin and metformin hydrochloride extended-release) are prescription drugs used in the treatment of type 2 diabetes. Sold by Janssen Pharmaceutical Companies of Johnson & Johnson and heavily prescribed between 2013 through 2017, Invokana has been linked to an increased risk of amputations, Fournier’s Gangrene, and other serious health risks.

The Invokana injury lawsuits attorneys at Williams Hart are actively investigating claims on behalf of patients who were prescribed the drug and suffered serious complications and injuries as a result taking it.

If you or a loved one have suffered from complications such as amputation of the leg, feet, or toes, DO NOT hesitate to contact Williams Hart today at (866) 303-0395 to schedule your FREE, no-obligation consultation.

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What is Invokana?

Invokana and related drugs are SGLT2 (sodium-glucose cotransporter 2) inhibitors, which are oral medications prescribed to treat type 2 diabetes. The drugs work essentially by preventing glucose from being absorbed into the kidneys. As a result, there is a decrease of glucose in the blood. The excess glucose is processed through urine.

SGLT2 inhibitors, such as Invokana, are generally used alone or with metformin, or other diabetic medications. When coupled with exercise and diet, these medications help to reduce blood glucose in adults with type 2 diabetes.

Accounting for 90% to 95% of all diabetes cases, type 2 diabetes occurs when the body is no longer able to use insulin correctly and blood glucose levels begin to rise to unsafe levels. This can lead to issues with the creation and processing of insulin within the body, as well as result in major health issues such as:

  • Kidney damage
  • Nerve damage
  • Loss of vision
  • Stroke
  • High blood pressure

map of united states outlining prevalence of diabetes

Invokana was approved for sale by the Federal Drug Administration (FDA) in March 2013 but the FDA required them to place warning labels on the packaging in 2017 to inform users about the increased risks associated with the defective drug. Sales have slumped since then, but unfortunately, the drug is still being prescribed.

If you have suffered any health issues as a result of taking Invokana or another SGLT2 inhibitor, do NOT hesitate to contact the defective drug attorneys at Williams Hart right now by dialing (866) 303-0395 or filling out our contact form.

Symptoms and Side Effects

Issues surrounding the use of Invokana were noted from as early as clinical trials. Common side effects associated with Invokana and other SGLT2 inhibitors include:

  • Genital yeast infections in men and women
  • Urinary tract infections (UTIs)
  • Increased urination
  • Yeast infections
  • Thirst
  • Constipation
  • Nausea
  • Fatigue
  • Weakness
  • Skin sensitivity to sunlight
  • Hypersensitivity reactions (i.e. skin redness, rashes, itching, hives & swelling)
  • Back pain
  • Flu-like symptoms

Serious side effects of SGLT2 inhibitors include:

  • Kidney failure
  • Stroke
  • Heart failure
  • Coma
  • Hyperkalemia (high levels of potassium in the blood)
  • Hypotension (low blood pressure)
  • Diabetic ketoacidosis
  • Increased cholesterol levels
  • Serious urinary tract infections
  • Increased bladder cancer risk
  • Serious allergic reactions
  • Low blood glucose (hypoglycemia) when combined with insulin or drugs that increase insulin production
  • An increased risk of bone fractures

One of the most daunting side effects is the increased risk for leg and foot amputations. In May 2017, the FDA issued a warning that “interim safety results from ongoing clinical trials found an increase in leg and foot amputations, [but] mostly affecting the toes.”

The Invokana website includes the following warning:

“INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body.”

Users of Invokana should be aware that some of these conditions may require emergency medical attention followed by long-term medical treatment. If you are dealing with any of the previously mentioned side effects, it is in your best interest to notify your doctor immediately.

FDA Black Box Warning

In May of 2017, the FDA issued a Safety Announcement regarding type 2 diabetes medicine canagliflozin (which includes Invokana, Invokamet, and Invokament XR). Their findings were based on two large clinical trials in which they concluded that SGLT2 inhibitors were causing an increased risk of leg and foot amputations.

The two clinical trials – the CANVAS and CANVAS-R – showed that leg and foot amputations occurred at nearly twice the rate for patients treated with canagliflozin compared to patients treated with a placebo. The CANVAS trial found that over a year’s time, the risk of amputation for patients in the trial stood at:

  • 5.9 out of every 1,000 patients treated with canagliflozin
  • 2.8 out of every 1,000 patients treated with placebo

The CANVAS-R study showed that over a year’s time, the risk of amputation for patients in the trial testing was equivalent to:

  • 7.5 out of every 1,000 patients treated with canagliflozin
  • 4.2 out of every 1,000 patients treated with placebo

The FDA warnings should be taken seriously by physicians; there are a number of factors that should be taken into consideration that predispose patients to amputations, such as previous amputations, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Physicians should also keep on eye on the development of ulcers, sores, pain or tenderness, “and discontinue canagliflozin if these complications occur,” as per the FDA.

chart utlining diabetes amputations

As a result of these findings, the FDA has since required Janssen Pharmaceuticals and Johnson & Johnson to provide “Black Box” warnings on the packaging of these products.

But this isn’t the only issue with Invokana and other SGLT2 diabetes drugs. Notable announcements include:

  • During clinical trials, 13 patients who were taking Invokana suffered a heart attack or stroke within the first 30 days of treatment.
  • In 2015, the FDA issued a warning that SGLT2 inhibitors may result in a serious condition of too much acid in the blood.
  • In 2015, the FDA issued a drug safety communication regarding the risks of bone fractures and decreased bone density for individuals who use Invokana.
  • In 2015 and 2016, multiple safety communications were issued regarding the increased risk of dangerous urinary tract infections and risk of kidney injuries for Invokana users.

Janssen Pharmaceutical has been very negligent about properly testing their products before releasing them out to unsuspecting users. Invokana has proven itself to be a very dangerous drug with extremely serious – and sometimes even deadly – side effects.

Diabetes and Dangerous Treatments

At Williams Hart, we know that the physical, emotional, and financial toll of dealing with the harmful side effects of these drugs can change your life forever. Do NOT let your pain go unheard. Contact us today at (866) 303-0395 to schedule your FREE, no-obligation consultation.

Damages We Will Fight For

Depending on the specifics of your defective drug claim, as well as the injuries suffered from taking an SGLT2, our dedicated product liability lawyers will fight to recover damages for but not limited to:

  • Medical Expenses – Compensation to cover current and future medical expenses related to your injury.
  • Pain and Suffering – Damages to cover quality of life changes.
  • Loss Wages and Future Earnings – Recovery of any lost or future wages if your injury does not allow you to return back to work.
  • Reduced Earning Capacity – Compensation to cover an inability to return to a previous job, an inability to get a promotion because of said injury, or any other hypothetical ability to earn a living.
  • Loss of Consortium – Damages to cover injuries that affect your relationships with your spouse and/or children.
  • Punitive Damages – This type of compensation is awarded when it is proven that the negligent company or manufacturer acted in a malicious, fraudulent, or grossly negligent behavior.

Contact Williams Hart today at (866) 303-0395 to schedule your FREE, no-obligation consultation.

Filing a Claim

All across the nation, individuals who have suffered as a result of Johnson & Johnson’s SGLT2 inhibitor are fighting against the negligently produced medication. Allegations include marketing without adequate clinical testing or post-market safety studies, misrepresented or concealed risks, and exaggerated benefits.

If you suffered an amputation of a leg, foot, or toe as a result of taking Invokana, Invokament, or Invokamet XR, you may be eligible to receive compensation for your defective drug injury.

If you or your loved one has suffered an amputation as a result of taking Invokona, contact Williams Hart immediately. With over 30 years of experience, we have the skills, knowledge, and ability to help you obtain the justice and recovery you deserve.

Greedy drug manufacturers do not have the right to take advantage of you and destroy your life. We are not afraid to take these corporations to trial and fight for you.

Contact us right now for a FREE, 100% confidential consultation with a member of our team today.

Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. announced in March 2013 that the FDA had approved Invokana (canagliflozin) for the treatment of adults with type 2 diabetes. Invokana is advertised as a once-daily pill with a 300-mg dose that was proven to show greater A1C (the abbreviation for glycated hemoglobin; A1C percentage measures how much sugar is attached to the blood’s hemoglobin protein) reductions than a competitor’s.
People who are dealing with type 2 diabetes may be prescribed several medications, and some may be uncertain about which drugs they may have taken. If you are not sure whether you were prescribed Invokana, the easiest way to get clarification is simply to speak to your health care provider and ask for a history of your medications.
Victims who have developed Fournier’s Gangrene after taking Invokana suffer some of the most horrific consequences imaginable after using the drug. These people could be entitled to various types of damages in these cases. Victims could be owed compensation for all past and future medical expenses as well as past lost wages and future lost income. Additional awards could include pain and suffering, emotional distress, and loss of consortium.
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