FDA Issues Black Box Warning for Invokana Due to Increased Risk for Amputation

The U.S. Food and Drug Administration (FDA) continues to strengthen warnings about Invokana and other drugs known as SGLT2 inhibitors that are used to help lower blood glucose levels in adults with type 2 diabetes.

The latest warning is the FDA’s strongest — known as a black box warning — and was issued amid concerns that Invokana has been linked to an increased risk for foot and leg amputations among users. These concerns were brought to light in a European drug trial that showed a higher incidence of lower extremity amputations among Invokana users.

Invokana has already been linked to an increased risk for kidney damage, blood infections and ketoacidosis, a potentially life-threatening condition caused by acid build-up in the blood. The drug was approved by the FDA in 2013; in 2015, the FDA issued its first warning about serious Invokana side effects, including injury to the kidneys and blood infections.

Medication like SGLT2 inhibitors treat type 2 diabetes by keeping the kidneys from absorbing glucose. People with type 2 diabetes have problems regulating their blood sugar, and these medications prevent the kidneys from absorbing too much. Instead, the glucose (sugar) is passed through urination without being absorbed.

Unfortunately, these drugs can also cause the body’s levels of glucose and insulin to drop too low. As a result, the body will start burning fatty acids, which can build up in the bloodstream causing diabetic ketoacidosis. Additionally, too much sugar in the urinary tract can lead to infections that may spread to the kidneys.

While SGLT2 drugs carried some warnings about increased blood acid levels, the warnings failed to mention the risk of diabetic ketoacidosis or kidney/urinary infections. This is especially important because patients who developed ketoacidosis while taking Invokana or similar drugs did not exhibit the normal symptoms (extremely high blood sugar). Instead, the drugs caused these patients to develop ketoacidosis while exhibiting low blood sugar, leading to delayed treatment and missed diagnoses.

If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.

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