This summer results from two clinical trials prompted the FDA to warn that popular type 2 diabetes medication, Invokana causes an increased risk for leg and foot amputation.
Why the Danger
Canagliflozin, the active ingredient in Invokana, lowers blood sugar levels in those with type 2 diabetes. It works by increasing the rate of excess sugar being removed from the body by the kidneys. Untreated diabetes is extremely dangerous; however, researchers are linking canagliflozin to a number of severe side effects. These include diabetic ketoacidosis and kidney damage.
Invokana & Amputation Risk
Now, the findings of two large clinical trials (CANVAS and CANVAS-R) showed evidence that patients taking Invokana are twice as likely to experience leg and foot amputation. Toe amputations are the most common. However, patients experienced middle of the foot and complete leg removals. Some also had multiple amputations including removal of both limbs.
Invokana Black Box Warning
In May, the FDA issued a black box warning after reviewing the CANVAS and CANVAS-R studies. This is the most serious warning a medication can receive. This is not the first time the Invokana has been the subject of safety concerns.
In 2015, the FDA warned that Invokana may lead to a serious condition called diabetic ketoacidosis (DKA). DKA occurs when the body cannot use sugar (glucose) as a fuel source because there is either too little or no insulin. Instead, the body breaks down fat for energy. The breakdown of fat produces ketones that can build up in the body. When these waste products build up in the blood, they become toxic.
In June 2016, the FDA strengthened the acute kidney injury (AKI) warning for Invokana. Kidney injury is a serious condition where the kidneys suddenly stop working and allow waste to build up in the body. According to the FDA, more than 100 people reported suffering kidney injury after taking Invokana between March 2013 and October 2015. There are reports of more unreported cases. About half of reported cases occurred within one month of starting the drug.
Mounting Invokana Lawsuits
Hundreds have already filed a lawsuit with Invokana manufacturer, Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. Plaintiffs are accusing the manufacturer of failing to warn health professionals and patients of the drug’s risks.
Over 450 serious adverse events reported to the FDA between March 2013 and March 2014, as documented by the Institute for Safe Medication Practices found this rate to be higher than 92% of other medicines regularly checked. The report notes the “clear evidence of harm” Invokana reaches the kidneys.
When a clear evidence of harm exists, you deserve to be compensated.
Invokana manufacturer, Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has netted almost $1 billion in profits from Invokana in the last year alone. Meanwhile, the number of individuals injured by Invokana have begun to accumulate. They have begun to file consumer protection lawsuits against the pharmaceutical giant.
At the present time, The Michael Brady Lynch Firm is concentrating on Pennsylvania. This is the location where our cases are pending against the makers of Invokana. As of June 2016, plaintiffs filed approximately 41 cases in Philadelphia involving people living all across the country. This will most likely mean a mass tort consolidation at the Federal level is imminent. Let our decades of experience bring you justice.