FDA Warns Of Invokana and Invokamet Amputation Risk

Invokana Bottles

Invokana and Invokamet (canagliflozin) help to control Type 2 diabetes. However, some patients have developed adverse side effects, including amputation. The results of two recent clinical trials showed that those who take Invokana, Invokamet or their generic equivalent, experienced foot and leg amputations twice as often as those who took the placebo drug.

The data from the two clinical trials prompted the Food and Drug Administration (FDA) to issue a drug safety communication. Janssen, the manufacturer of Invokana and Invokamet, is now required to add a black box warning to inform patients of the amputation risk. There are already black box warnings in place to alert patients to the possible ketoacidosis and kidney failure side effect risk.

The most common amputations affected the toes and feet. However, there were clinical trial participants who reported leg amputations and above-the-knee amputations. Instances where multiple limb amputations were reported.

FDA Warning For Invokana and Invokamet

While a similar drug safety communication was issued in May 2016, the clinical trials were just starting at that time. Therefore, there was insufficient data to definitively link canagliflozin to the increased amputation risk. Now that the results of the clinical trials have produced clear data linking the drugs’ use with heightened amputation risk, the FDA has decided to take action.

Should I Stop Taking Invokana / Invokamet?

No, you should not stop taking this medicine without first consulting with the prescribing doctor. Stopping medication on your own can cause dangerously high blood sugar levels, which can lead to organ damage, blindness, and even death. Make sure to inform your doctor if you are experiencing any new leg or foot issues, including infections, pain, tenderness or sores.

If you are using Invokana, Invokamet or a generic equivalent, you should let your doctor know if you have a prior history of amputation, foot ulcers, neuropathy or vascular disease. Patients with these health issues could have an increased amputation risk while taking Invokana, Invokamet or canagliflozin. It is important that you disclose any of the above health issues to your doctor as he or she may choose an alternative treatment for your Type 2 diabetes.

How Do I Make An Invokana / Invokamet Side Effect Claim?

If you or a loved one has had a toe, leg or other body part amputated while using Invokana or Invokament, you may be entitled to compensation for your injuries. Contact our Invokana Lawsuit Attorneys now for a free and confidential consultation. Call 1-800-718-4658 now.

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