Recent Invokana Clinical Trials Show Drug Doubles Risk of Amputation—Causing FDA to Issue a Black-Box Warning
People who suffer from Type 2 diabetes may be prescribed Invokana, Invokamet, and Invokamet XR (SGLT2 inhibitors) to help lower blood sugar. Invokana was the first drug of a new treatment for Type 2 diabetes called SGLT2 inhibitors, which force the kidneys to excrete more sugar in urine to lower the levels of sugar in the blood. Invokana was first approved by the U.S. Food and Drug Administration (“FDA”) in March 2013. However, after a study showed that patients on SGLT2 inhibitors were twice as likely to develop ketoacidosis (a life-threatening condition that occurs when the blood becomes too acidic) and 73 cases of ketoacidosis were reported to the FDA, the FDA issued several Safety Alerts and required the label to contain a warning for the risk of acute kidney injury, kidney failure, and ketoacidosis. (See https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm.)
Today, the drug makers of Invokana are facing another round of Safety Alerts from the FDA. In May 2017, the results of two independent studies by Johnson & Johnson’s Janssen Pharmaceuticals showed that the risk of amputation doubled for patients taking Invokana compared to those taking the placebo. The results of these two studies (CANVAS and CANVAS-R) caused the FDA to issue its most prominent type of warning (a “black box”), requiring the increased risk of amputation be included on the labels of Invokana, Invokamet, and Invokamet XR. (See https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm.)
Although there are other SGLT2 inhibitors on the market—Farxiga and Jardiance—the amputation risk only seems to plague Invokana. (See http://www.fiercepharma.com/marketing/astrazeneca-boehringer-cry-no-class-effect-after-j-j-s-invokana-doubles-amputations-study.)
Michael Woerner and a team of attorneys at the law firm of Keller Rohrback L.L.P., are investigating cases involving patients who took Invokana, Invokamet, or Invokamet XR and suffered an amputation as a result. They can be contacted at (800) 776-6044, email email@example.com, or by filling out the Contact Box. Keller Rohrback L.L.P., 1201 Third Ave., #3200, Seattle, WA 98101. Attorney Advertising. Prior results do not guarantee a similar outcome. Not licensed to practice law in all states. Please refer to our website for details.