Reports of amputations connected to canagliflozin, the key ingredient in brand name medications Invokana and Invokamet, continue to underscore the drug’s dangers that prompted new Food and Drug and Administration (FDA) black box warnings. Patients “with no discernible risk factors for amputation” are even at risk, according to Medscape Medical News.
Invokana and Invokamet, which is a combination of Invokana and metformin, are drugs prescribed to patients with Type 2 diabetes to help lower their blood sugar. They are in a class of drugs known as sodium-glucose cotransporter-2 or SGLT2 inhibitors that have been linked to kidney damage.
As Beasley Allen previously reported, earlier this year the FDA required Johnson & Johnson’s Janssen Pharmaceuticals, the maker of the drugs, to include new black box warnings that describe the risk of leg and foot amputations. The latest adverse side effect was discovered during the clinical trial called Canagliflozin Cardiovascular Assessment Study (CANVAS/CANVAS-R). While the study was conducted to monitor the drug’s cardiovascular risks, it revealed that Invokana doubled the risk of lower limb amputation when compared to the outcomes for patients taking a placebo.
Data collected through the FDA’s adverse-event reporting system (FAERS) that have recently been published shows that 86 percent of reported amputations associated with SGLT2-inhibitor were connected to canagliflozin. Further, the information discloses that two-thirds of the reports involved people who were not determined to be at risk for amputation.
The data was collected from patients voluntarily reporting events and published in Lancet Diabetes & Endocrinology by Dr. Gian Paolo Fadini and Dr. Angelo Avogaro with the University of Padova, Italy. They note that other SGLT2 inhibitors, such as empagliflozin (Jardiance) or dapagliflozen (Farxiga), did not show the same effect, Righting Injustice notes. Yet, the report’s authors stop short of recommending either dapagliflozin or empagliflozin over canagliflozin, saying that more research is still needed.
Invokana’s initial troubles began after patients who took the drug developed severe kidney damage called diabetic ketoacidosis (DKA), which occurs when too much acid builds up in the blood. It is at the center of more than 600 lawsuits, according to the U.S. Judicial Panel on Multidistrict Litigation, that are part of a multidistrict litigation (MDL) in New Jersey federal court. Within the first two years Invokana was on the market, the FDA received more than 100 reports of acute kidney injury in patients taking the drug. In response, the FDA ordered a stronger kidney warning accompany several SGLT2 inhibitors including Invokana and Invokamet. The MDL’s first bellwether trial is slated for September 2018.
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Lawyers in Beasley Allen’s Mass Torts Section are investigating claims on behalf of individuals and families who say they were injured by Invokana and Invokamet, specifically cases involving DKA, acute kidney injury, heart attack and stroke. If you would like more information, contact Danielle Ward Mason, a lawyer in our Mass Torts Section. She can be reached at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.
Medscape Medical News
U.S. Judicial Panel on Multidistrict Litigation