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Invokana FDA Approval History: What Patients Need to Know

According to a 2018 CDC report, more than 100 million people in the United States have diabetes or prediabetes. The FDA has targeted the medication Invokana, or Canagliflozin, which is used to treat Type II diabetes in adults, as a potentially dangerous drug and have issued several warnings as a result. Some of the dangers with Invokana are amputation (particularly of the lower limbs), gangrene, and ketoacidosis. If you live in the United States and have suffered negative consequences due to ingesting Invokana, you may be eligible for compensation. The US product liability lawyers with Carabin Shaw will help you understand the next steps you can take. If you are interested in the Invokana FDA approval history, here’s what patients need to know.

What is Invokana?

Doctors prescribe Invokana, alongside proper diet and exercise, to treat Type II diabetes. Untreated Type II diabetes can induce harm to cells and organs and cause kidney damage, blindness, and increased risk for heart attack or stroke. It is a sodium-glucose cotransporter 2 inhibitor that works with the kidneys to remove excess blood sugar through urine. Also known as Canagliflozin, it can be paired with other chemicals to create Invokamet. Invokana can cause serious side effects, and if you have experienced any of these, contact a US lawyer with Carabin Shaw today.

Invokana and the FDA

Given the complex Invokana FDA approval history, here some things patients should know. Is Invokana FDA approved? Yes, it is. Although it is approved, the FDA has issued numerous warnings about Invokana. These Invokana FDA warnings concern lower limb amputations, kidney problems, and gangrene. Here is a quick timeline:

  • May 2012: Invokana submits an application to be a treatment for Type II diabetes in adults
  • March 2013: FDA approves Invokana to treat Type II diabetes in adults
  • June 2016: FDA issues warning for a potential increase in kidney problems with Invokana users
  • May 2017: FDA issues warning about increased lower limb amputations
  • July 2017: FDA issues warning about amputations
  • September 2018: FDA warns about “rare” occurrences of gangrene
  • October 2018: FDA approves Invokana to reduce the risk of heart attack and stroke in patients with Type II diabetes and cardiovascular disease

If you believe you have suffered due to Invokana, contact a US lawyer with Carabin Shaw to help with your case.

Invokana and Amputations

Two large medical trials were conducted about the correlation between Invokana and lower limb (toe, foot) amputations. These students indicated that those who took Invokana as opposed to the placebo were twice as likely to have an amputation. The Invokana risk for amputation is higher than usual, which is why people should be cautious while taking this particular medication.

According to the FDA, the chance of amputation is higher in individuals who have a history with peripheral vascular disease, nerve damage, or diabetic foot sores. The Mayo Clinic reports that 80 percent of amputations begin with foot ulcers due to the vulnerability of the skin. So, cleaning your feet daily, not smoking, and contacting a doctor when ulcers occur can help prevent your chances of amputation.

If you have been afflicted by taking Invokana, or have experienced an amputation because of Invokana, US product liability lawyers are waiting to hear your case.

Call Carabin Shaw Today

If you live in the United States and Invokana caused an amputation or another serious issue, you might be eligible for financial compensation. Talking to a US lawyer with Carabin Shaw will aide in navigating the next legal steps. If you suspect Invokana is causing health problems, speak to a medical professional right away. Fortunately, there are Invokana alternatives. It is essential, however, that you do not immediately stop your medication. If you are concerned about the impacts of Invokana on your health, talk to a doctor first. What patients need to know about Invokana FDA approval history is that this medication is still fairly new. It has been investigated and is still approved by the FDA, despite their warnings.

If Invokana has caused you pain, consider reaching out to a US attorney with Carabin Shaw today. Our lawyers will not charge you unless we win your case, and your initial consultation with us is free. Call us at 800-862-1260 to schedule an appointment.

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