FDA Warns the Diabetes Drug May Lead to Leg and Foot Amputations

Canagliflozin, a drug which has been used to treat those suffering with type 2 diabetes, is now the subject of an alert issued by the Food and Drug Administration (FDA). According to the FDA the drug can cause serious side effects to those who use it, including an increased risk of leg and foot amputations. Despite the alert, the FDA has not concluded that the drug is to blame, and the investigation continues to determine if there is any causal link.

There are several prescription medications which include canagliflozin among their ingredients, including the type 2 diabetes drug Invokamet, which is canagliflozin combined with another drug called metformin. Additionally, canagliflozin is sold as a single ingredient drug in medications such as type 2 diabetes drug Invokana. Invokana is used by those suffering from type 2 diabetes in order to lower their blood sugar, which is the effect of the drug’s causing the body to remove sugar by excreting it through the kidneys into the urine.

There are currently several lawsuits pending against companies which manufactured Invokana including:

• Johnson and Johnson
• Mitsubishi Tanabe Pharma Corporation
• Janssen Pharmaceuticals,Inc.
• Janssen Ortho

The lawsuits targeting Invokana manufacturers center around the fact that those who were prescribed the drug were not warned by the manufacturers that by taking it they were being put at increased risk of a serious condition called diabetic ketoacidosis, among other serious side effects. Diabetic ketoacidosis is a condition in which the body’s blood becomes significantly more acidic, and can cause severe illness or even death.

The serious side effects associated with taking Invokana affected not only those who had taken the drug for an extended period of time, but could also strike those who had only recently begun to take the drug. In several of the recent lawsuits the plaintiffs assert that the manufacturers of Invokana knew about these risks and hid them from the patients and their doctors, essentially putting profits over people.

At the conclusion of its investigation the FDA will make its findings public, and determine what additional steps to take.