CORONAVIRUS UPDATE: What We Are Doing to Protect Our Clients

New Amputation Safety Warning Label for Diabetes Drug Invokana

New Amputation Safety Warning Label for Diabetes Drug Invokana

Amputation Safety Warning 

Every week, my office provides clients with news updates concerning topics related to personal injuries. Some of these articles target specific medicines like the diabetes drug Invokana that has caused so many patients to suffer negative side effects. It’s now believed that Invokana (canagliflozin) can increase patients’ chances of one day requiring a foot or leg amputation.

Other reported side effects include urinary tract problems and ketoacidosis – this latter condition can become life-threatening and require hospitalization. Jenssen Pharmaceuticals, Invokana’s manufacturer, also warns patients that this drug can increase their chances of suffering bone fractures and various allergic reactions.

However, a recent 2017 news story about the U. S. Food and Drug Administration (FDA) requiring a new “black box” warning label for Invokana and related drugs is particularly alarming since it involves an increased chance of future amputations.

New Warning Label Regarding Amputation Risks

In early May 2017, the U. S. Food & Drug Administration (FDA) advised Johnson & Johnson (parent company to Jennsen Pharmaceuticals, Inc., the manufacturer of Invokana), that it must begin placing new warning labels on this drug — and its other forms sold as Invokamet and Invokamet XR.

This new warning label requirement was issued after two major clinical trials (CANVAS-R and CANVAS) run by the manufacturer not only failed to prove the safety of Invokana – they documented the heightened future risk for amputations it poses for some patients.

Specific Requirements for the New Invokana Warning Label

This new label requires the highest form of warning required for a product manufactured and sold in the United States –  the FDA’s “black box” label. It must clearly inform patients that taking this drug can significantly heighten the chances that they may later need to amputate a foot or leg.

While this new warning may frighten away some potential patients, people still highly recommend Invokana. They claim that its possible side effects are outweighed by all its likely benefits. These same supporters claim that if the government was truly concerned about this drug’s potential complications, they simply would have issued a full drug recall.

Of course, all patients and their doctors are strongly urged to thoroughly discuss this new drug warning. Together, they can decide if Invokana remains the most promising drug available. Or, if another one that’s equally or more viable poses far fewer potentially debilitating side effects.

What Other Major Medical Risks Are Associated with Invokana?

On its own website for this drug, Janssen Pharmaceuticals (a Johnson & Johnson company) sets forth some of the following potential side effects (not already named above) that some patients may have to address.

  • A heightened need to urinate – often at night – and possibly in much greater volume;
  • Low blood sugar (hypoglycemia). Symptoms of this can include dizziness, headaches, a fast heartbeat, and drowsiness;
  • Yeast infections involving either the patient’s vagina or penis;
  • A higher amount of potassium in the patient’s blood.

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Sacramento Personal Injury Lawyers

I’m Ed Smith, a Sacramento personal injury lawyer. Traumatic injuries, such as amputation, can drastically change one’s life. If you, or a family member, have been seriously injured by the negligence of another, please call me today. You can reach me at (916) 921-6400 for free and friendly advice. If you are out of the area, feel free to use my toll-free number at (800) 404-5400.

I have been helping Sacramento Area families in their injury and wrongful death claims since 1982.

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