Johnson & Johnson's Medication Invokana Has Led To Amputations

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Have You Been Prescribed Invokana For Diabetes?

Invokana was introduced to help regulate Type II Diabetes. It is marketed as a once-a-day medication to lower blood sugar. Invokana, manufactured by Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, is within the class of SGLT2 inhibitors. SGLT2 is a sodium-glucose transporter. Once inhibited, the kidneys can produce more glucose toInvokana lower blood sugar levels. Invokana was approved by the FDA in 2013, and has been on the market since.

In 2016, the FDA issued their first Safety Communication regarding Invokana and amputations. It concerned the interim clinical trial results from CANVAS (Canagliflozin Cardiovascular Assessment Study). Although CANVAS started out as a clinical trial for the major heart-related effects, after four and half years of the study the amputation risks showed to be far higher for those taking Invokana versus those taking a placebo. The analysis showed that over a year’s time, amputation risks were:

  • 7 out of every 1,000 patients treated with 100 mg daily of Invokana (canagliflozin)
  • 5 out of every 1,000 patients treated with 300 mg daily of Invokana (canagliflozin)
  • 3 out of every 1,000 patients treated with placebo

Invokana Has Been Linked To Necessary Foot & Leg Amputations

After this analysis, the FDA investigated the increased risk of foot and leg amputations. In 2017, the FDA issued another Safety Communication confirming the risk of leg and foot amputations involving those taking Invokana. The FDA required a Black Box Warning to be added to the label, the FDA’s most prominent warning. From the final results of CANVAS and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus), showed that patients were twice as likely to receive an amputation taking Invokana than those taking the placebo. The FDA noticed that toe and middle of the foot as the most common amputations, followed by the leg (above and below the knee). There were instances that both limbs had to have a form of an amputation. Click for the FDA’s data summary available on their website.

Legal Help Is Available For Users Of Invokana

If you or your loved one suffered an amputation after taking Invokana, you may be entitled to a claim against the manufacturer Janssen Pharmaceuticals. In order to learn more about your legal rights you need to speak with an experienced lawyer as soon as possible. Please feel free to contact us online or call us directly at 318.541.8188 to schedule your free consultation.