New Invokana Black Box Warning Required by FDA

FDA requires new warning on Invokana

Earlier this week, the U.S. Food & Drug Administration (FDA) told Johnson & Johnson – the massive, multinational manufacturer of drugs, medical devices, and consumer products – to include new warning labels on its diabetes drug Invokana, as well as variations of the drug sold under the brand Invokamet and Invokamet XR.

Invokana Amputation Warning

The new black box warning informs patients that they could face a higher risk of needing an amputation after taking canagliflozin or one of its derivatives. This comes from two large clinical trials, both of which demonstrated that one of the many Invokana side effects is a significantly increased risk of leg and foot amputations. Black box warnings are the highest level of required warning for drugs manufactured and sold in the U.S. The new boxed warning is not required on the labels of other SGLT2 inhibitors, such as Jardiance and Farxiga.

According to the FDA safety communication released Tuesday, the clinical studies showed that amputations were nearly twice as common in patients who took canagliflozin versus those who received a placebo. The studies, known as CANVAS and CANVAS-R, which were conducted by Johnson & Johnson as part of a larger cardiovascular study, shared similar results. The company had been hoping that the studies would show Invokana to be safe, but instead they revealed a need for even greater caution.

This is not the first time the drug has been the subject of safety concerns. More than 700 cases have been filed under the Invokana MDL, with another 700 pending as of October 2017. Invokana lawsuit claims were made due to the drug’s side effects, including the increased risk of amputation.

Is Invokana Safe?

Did you know?

About 8 people out of every 1,000 taking Invokana are at risk of needing an amputation

Although this new warning is being added to show the increased risk of amputation while taking the drug, it is worth noting that the FDA has not required a recall or pulled the medication from the market completely. According to the CANVAS and CANVAS-R study results, the risk of amputation affects approximately 6 – 8 people out of every 1,000 individuals who take the prescription medication.

Nevertheless, patients and their loved ones should still be cautious when taking Invokana. The FDA has provided the following guidelines for patients who are taking the medicine:

  • If you start notice new pain, tenderness, sores, ulcers, or infections in your legs and feet, notify your doctor immediately.
  • Do not stop taking diabetes medications without first talking to your doctor.
  • If you have a history of amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers, you may be at a higher risk of amputation when taking Invokana.

As always, when in doubt, talk with your doctor about the risks of taking Invokana, and be sure to ask if there are other ways to manage or treat type 2 diabetes.

Authored by Curtis WeyantContributor
Photo of Curtis Weyant
Curtis Weyant has more than 20 years as a writer, editor, and communicator, publishing on a wide variety of topics, especially in the financial, legal, and medical fields. At, Curtis managed the day-to-day publication of all content from 2016-2019.
Editorial Standards Full Bio