First, the FDA issued new requirements to add the Boxed Warning to canagliflozin drug labels to include the increased risk of lower body amputations. The FDA also issued warnings to patients to notify their doctors if any pain, tenderness or sores developed in their feet. However, they have not removed the drug from the market and do not recommend the cessation of taking the medication without instructions from the doctor.
Of course, this has also led to a series of lawsuits against the manufacturer of Invokana, Janssen Pharmaceuticals. Currently, there are over 1,000 lawsuits pending against the Johnson and Johnson subsidiary, with many having filed over claims that the drug caused their amputation. Litigation has expanded into Canada, with patients filing a class-action lawsuit against the manufacturer. And while there have not been any further cases filed, Janssen recently cut a deal with U.K. company Mundipharma to distribute the drug to the British and European market.
Litigants across the United States assert that the manufacturers negligently made the drug, and then lied about the risks and side effects without properly warning the doctors and public. Had they known about the increase in risk for amputation, they would not have taken the drug. Patients have requested compensation for pain and suffering, medical costs, attorney’s fees and even punitive damages in some cases.
Marketed as Invokana, Invokamet, or Invokamet XR, canagliflozin is a prescription drug used in conjunction with diet and exercise to lower the amount of glucose in the blood levels of adults who suffer from Type 2 diabetes. It has been one of the highest selling prescription drugs for Type 2 diabetic patients, netting Janssen Pharmaceuticals over $1 billion in profits from Invokana alone in one year. The class of drug it belongs to is SGLT-2 inhibitors. It works by removing blood sugar from the kidneys through the urine.
As you can tell from the initial purpose of the CANVAS and CANVAS-R studies, Invokana carries with it multiple other side effects aside from potential amputation. Because Invokana works in increasing filtration through the kidneys, there have been serious problems with patients who have taken Invokana and their renal systems. In some cases, kidney failure has occurred, with patients now having to resort to dialysis in addition to regular treatments for their diabetes. Since 2013, when the FDA initially approved Invokana, the FDA has received 101 reports of acute injury – 4 cases resulted in a fatality. In the majority of cases, the acute kidney injury occurred within a month of starting the drug.
Ketoacidosis is also another side effect of Invokana, all of which require visits to the hospital. The drug has also been linked to frequent urinary tract infections, blood clots, and blood infections. Interestingly enough, the risks for cardiac events (such as heart attacks) appears to have been lowered in patients taking canagliflozin than those taking the placebo.
The black box warning for the risk of amputation was added to Invokana packaging in May 2017; therefore, anyone who suffered some sort of lower limb amputation before that date might have the standing to file their own action against the manufacturer. There is still time to file. The first ‘bellwether’ trial is slated to begin in September 2018. If you or a loved one have suffered an injury from Invokana, particularly a lower limb amputation, you deserve to be compensated for what you have lost. Contact the law offices of Paul Schiffer at 832-920-0434
Invokana™ is a registered trademark of Janssen Pharmaceuticals, Inc. The use of any trademarks marks are solely for informational and product identification purposes