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FDA adds "black box" warning to popular diabetes drug Invokana

Following months of review of anecdotal and statistical evidence, the U.S. Food and Drug Administration has recently strengthened warnings on the packaging of one of the most popular drugs for the treatment of Type 2 diabetes. The medicine, canagliflozin is sold under the brand names Invokana, Invokamet and Invokamet XR.

In theory, the medication helps diabetes patients better manage their insulin and blood sugar levels. In addition, it should prevent internal damage from diabetes symptoms.

The medication was introduced for sale in 2013 and quickly became one of the most popular diabetes drugs on the market. Countless patients have taken Invokana since then in order to:

  • Control blood sugar;
  • Lower A1C levels;
  • Prevent kidney damage often associated with diabetes; and
  • Lower the risk of amputation caused by diabetes. (In some people, uncontrolled diabetes can cause circulatory issues, leading to infections, lack of blood flow, nerve damage and more.)

Tragically, the very same drug that should have lowered patients' risk of diabetes-associated amputations may have caused them. Two large-scale clinical trials reviewed by the FDA in 2016 showed that people taking Invokana suffered amputations at nearly twice the rate of people given a placebo.

The FDA advises that medical professionals use caution when prescribing Invokana, particularly if patients have risk factors for amputation. These include:

  • History of prior amputation of limbs or digits;
  • Vascular disease;
  • Neuropathy;
  • Diabetic-related foot ulcers;
  • Delayed healing of wounds, particularly in the lower extremities; and
  • Other serious diabetes-associated conditions (blindness, nerve damage, kidney damage, or heart disease).

Were you prescribed Invokana to manage your Type 2 diabetes and suffered an amputation as a result? Or maybe you or a loved one suffered kidney failure or developed ketoacidosis, also known as diabetic ketoacidosis (DKA) or ketosis, after taking Invokana. Both of these conditions have also been linked to Invokana. If so, consult an experienced personal injury attorney in your area to learn more about your legal rights and options.

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