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Invokana Warnings Continue To Rise

At some point, you just have to ask — What’s next? That’s a good question for the diabetes drug Invokana. At the Blackwell Law Firm we began investigating Invokana when the drug was initially linked to ketoacidosis. If you want to learn the basics about Invokana and its development as a diabetes drug, we have a section devoted to the topic on our firm website. As discussed in that section, ketoacidosis is a serious and potentially fatal build-up of acid in the blood. Symptoms of ketoacidosis can include:

  • Confusion
  • Abdominal Pain
  • Breathing Difficulty
  • Abnormal Sleepiness or Fatigue
  • Nausea or Vomiting

In our opinion, ketoacidosis is a serious danger the manufacturer Johnson & Johnson should have researched (or warned about) before exposing patients to harm. Instead, the company chose to market the drug to innocent patients including many consumers in Alabama. Only after patients began to suffer injury did the adverse health link come to a public light. And, the FDA then issued a safety communication in May 2015 warning patients about the risk of ketoacidosis from Invokana.

Although ketoacidosis is a serious health concern, it’s not the only issue potentially linked to Invokana. The drug continues to be linked to other adverse health concerns and injury risks.

In September 2015, the FDA mandated another warning. This time, the FDA communicated a potential link between Invokana and decreased bone density as well as fractures.

In May 2016, the FDA issued yet another safety communication about Inovkana. Now, the FDA warned about Inovkana and questions regarding a potential link to foot/leg amputations. You can read the FDA communication in one of our prior blog posts.

That brings us back to my original question about Invokana — What’s next? On June 14, 2016, the FDA issued a new Safety Announcement about Invokana. This new announcement discusses and strengthens FDA communications about the risk of kidney injury for the class of drugs which includes Invokana. Here is the introductory paragraph from the June 2016 FDA communication:

The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

Where is Invokana now? For Johnson & Johnson, it’s a money maker. A giant money maker. For patients, it’s a drug with huge safety questions. And, the answers to those questions could involve life-changing injuries or even deaths. We continue to investigate these potential injury cases on behalf of our clients.