FDA warns Invokana can increase amputation risk for diabetes patients

by John Chapman

Diabetes patients taking Invokana and other medications containing the drug canagliflozin may face an increased risk of lower limb amputation, according to a new warning by the Food and Drug Administration. The FDA is requiring the manufacturers of Invokana and other canagliflozin drugs to add a “black box” warning about the risk of limb amputations to the labeling for these medications.

Invokana and other medications containing canagliflozin (including Invokamet and Invokamet XR) are used to treat patients with type II diabetes. The drugs are designed to help patients by lowering blood sugar levels and helping to reduce complications experienced by many diabetes patients. Canagliflozin is part of a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Canagliflozin is sold under the brand name Invokana, or in combination with the diabetes drug metformin under the brand name Invokamet.

The FDA’s warning about Invokana was based on the results of two clinical trials known as CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus). These studies found that patients who used Invokana and other medications containing canagliflozin were twice as likely to undergo leg or foot amputations than patients not using these drugs.

The CANVAS and CANVAS-R studies found that toe and middle foot amputations were the most common side effects suffered by Invokana users. Some patients were also forced to undergo other forms of amputation, including amputation of the leg either below or above the knee. In some cases, patients were forced to undergo multiple amputation, including some involving both legs.

The FDA has advised patients taking Invokana or other canagliflozin medications to notify their doctor if they experience symptoms affecting their legs or feet, including pain, tenderness, sores, ulcers, or infections in those areas. The agency is advising doctors to consider using other drugs besides Invokana to treat diabetes patients who have a history that could predispose them to an increased risk of amputations, including previous limb amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers.

In July 2016, the FDA also warned that patients taking Invokana could face an increased risk of diabetic ketoacidosis or other kidney injuries. Johnson & Johnson, the manufacturer of Invokana, is facing lawsuits filed on behalf of Invokana patients who suffered diabetic ketoacidosis or other kidney injuries after taking the drug to treat their type II diabetes symptoms.

Lawsuits Filed on Behalf of Invokana Users

If you or a loved one suffered kidney failure, kidney damage, or diabetic ketoacidosis after using Invokana or other medications containing canagliflozin, you may be eligible to file a lawsuit and seek compensation. The first step in taking legal action is to consult with an attorney to find out more about your legal rights and discuss the first steps in filing a claim.

The lawyers at Heygood, Orr & Pearson has filed hundreds of lawsuits involving pharmaceutical liability or other product liability matters on behalf of our clients. Our law firm has tried hundreds of cases to verdict and have achieved settlements in hundreds more, achieving damages on behalf of the individuals we represent totaling hundreds of millions of dollars. At Heygood, Orr & Pearson, we believe that when pharmaceutical companies and other corporations manufacture drugs or other dangerous medical products that harm patients, they should be held responsible for their negligent actions in a court of law.

Heygood, Orr & Pearson is one of the leading pharmaceutical tort law firms in the United States. Our lawyers have handled more litigation claims involving the powerful fentanyl pain patch than all other law firms in the U.S. combined. Heygood, Orr & Pearson has filed lawsuits involving a number of other dangerous drugs, including the blood thinners Pradaxa or Xarelto, Yasmin birth control pills, the diabetes drugs Actos and Avandia, Zofran, and other medications.

For more information about the side effects of Invokana and to learn more about whether you may qualify to file a lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few brief questions about your history to get started.

by John Chapman

John Chapman is a licensed attorney with experience in complex commercial litigation (including securities fraud, RICO, shareholder oppression, and derivative actions) and personal injury litigation.