Invokana Amputation Risks, Warnings, and Lawsuits

Yellow Warning Symbol Used for InvokanaInvokana® was supposed to protect you from some of the serious complications of type 2 diabetes. By inhibiting sodium-glucose co-transporter 2s (SGLT2s) in your body, Invokana allowed more glucose to be released in your urine and less glucose to be reabsorbed by your kidneys.

The goal was to lower your blood glucose levels and to keep you healthy. As with any medication, however, there were side effects. You may have reviewed those side effects on your own or with your doctor before deciding to take Invokana. However, you could only weigh the known side effects against the potential benefits of the drug.

Amputation Black Box Warning

When you decided to take Invokana, you may not have known that it could cause a possible amputation. It wasn’t until 2017 that the U.S. Food and Drug Administration (FDA) required Janssen Pharmaceuticals to add a black box warning about amputations to Invokana medications.

On May 16, 2017, the FDA announced that based on the outcomes of two large clinical trials, canagliflozin medications, including Invokana, Invokanamet, and Invokanamet XR, are required to carry the agency’s most significant warning—a black box warning. The black box warning must warn patients about the risks of leg and foot amputations.

The Invokana label now includes a box that reads:

WARNING: LOWER LIMB AMPUTATION

  • An increased risk of lower limb amputations associated with INVOKANA use versus placebo was observed in CANVAS (5.9 vs 2.8 events per 1000 patient-years) and CANVAS-R (7.5 vs 4.2 events per 1000 patient-years), two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD [see Warnings and Precautions (5.1)].
  • Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs [see Warnings and Precautions (5.1)].
  • Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers [see Warnings and Precautions (5.1)].
  • Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur [see Warnings and Precautions (5.1)].

Invokana Amputation Lawsuits

Various Invokana amputation lawsuits have been filed around the country. Those lawsuits include:

  • Multidistrict litigation (MDL) in New Jersey state court. In late 2016, an Invokana MDL was created so that Invokana cases could be heard by a single judge.
  • Federal lawsuits. Lawsuits have been filed against Janssen Pharmaceuticals in United States District Courts.

The plaintiffs in these cases allege that Janssen failed to warn patients and doctors about the potential risk of amputations and the need for medical monitoring because of the amputation risk and that they were hurt as a result of the pharmaceutical company’s failure to warn.

What to Do After an Invokana Amputation

As you well know, an amputation can change your whole life. The physical pain, the endless doctors’ appointments, the interference with your daily activities, and the emotional suffering are intense.

You are doing everything that you can to live your best life now. A successful Invokana amputation lawsuit can help you do that by getting you compensation for your past and future:

  • Medical expenses. Your medical expenses include your surgeries, hospitalizations, medications, physical therapy, prosthetics, and other healthcare needs.
  • Lost income. Your amputation may have interfered with your ability to work. Any lost wages, benefits, or income from self-employment may be part of your recovery.
  • Pain and suffering. The significant physical pain and emotional suffering you have already experienced and will continue to experience should be part of your recovery.
  • Out-of-pocket costs. Any other costs, including but not limited to modifications to your home or car, should be part of your recovery.

Additionally, you may feel some relief and satisfaction holding Janssen Pharmaceuticals and its parent company Johnson & Johnson accountable for your injuries.

For help pursuing an Invokana amputation case, please contact our New England Invokana injury lawyers for a free consultation. We will provide you with an honest and thorough review of your claim so that you can make an informed decision about what steps to take if you’ve been hurt by Invokana, Invokanamet or Invokanamet XR.

 

John L. Keefe
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Founding Attorney, Massachusetts Social Security Disability Lawyer