Invokana was the first in a new class of drug for Type 2 diabetics. It was supposed to help people easily manage their diabetes without insulin by lowering blood sugar by causing the kidneys to remove sugar from the body via urine. This prevents blood from reabsorbing the sugar. In March 2013, the FDA approved Invokana. However, by May 2015 they were warning that Invokana may lead to devastating side effects.
Invokana & Amputation
Based on new data from two large clinical trials, the FDA issued a new Black Box warning for the Type 2 diabetes drug, Invokana, Invokamet and Invokamet XR. Both studies the organization reviewed showed an increased risk of leg and foot amputations to patients using Invokana. Because of this, the FDA required Invokana to have a Black Box warning, the most severe warning the FDA can give, about leg and foot amputations.
The FDA made the decision after reviewing two large studies the 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). CANVAS found that 7 out of 1,000 patients taking Invokana will need lower-limb amputation. This is a twofold risk of amputation. Invokana is the best-selling inhibitor drug on the market for Type 2 diabetes. Therefore, hundreds of thousands of people who take Invokana are completely unaware that a seemingly innocent cut on a toe, may lead to amputation because of their Invokana use.
Invokana & Kidney Damage
While using Invokana, the kidneys remove sugar from the body. Kidneys also filter waste products from the bloodstream. However, when Invokana damages the kidneys, they can stop functioning. When the kidneys fail, a buildup of waste in the blood may occur. Dialysis is needed to reverse the effects of kidney failure.
From the time the FDA approved Invokana, they received 101 reports of acute kidney injury. Of these cases, 96 patients required hospitalization. Twenty-two required intensive care. Four patients died while hospitalized. In about 50 percent of these cases, acute kidney injury occurred within one month or less of starting the drug.
According to the FDA, 56 of these patients discontinued the medications and saw some improvement, but it warned that kidney injury is not reversible in all situations.
FDA Label Changes
The FDA revised labeling to warn of acute kidney injury when taking canagliflozin. This is the active ingredient in Invokana. Along with the label change, the FDA also advised doctors and health care professionals to consider risk factors that could predispose patients to acute kidney damage. These include low blood volume, congestive heart failure, and certain medications. The medications include diuretics, blood pressure medications known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs).
Invokana & Ketoacidosis
Diabetic ketoacidosis is a dangerous complication of diabetes. Around 14% of all diabetics are hospitalized because of it. This illness can lead to coma and death. Researchers linked DKA to 16% of all diabetes-related deaths.
DKA happens when the body starts using fats as fuel instead of sugar or glucose. Insulin aids the body in using sugar as fuel, but when a person has diabetes the body cannot use sugar for fuel. Instead, it uses fat. When the fat is brown down, it causes the body to produce acidic chemicals called ketones. Ketones build up and poison the body. This build-up can cause organs to malfunction.
According to the FDA, there were at least 20 cases of ketoacidosis associated with the class of SGLT2 inhibitors drug within 15 months. All these cases require visits to the emergency room or hospitalization.
But that’s nothing compared to 457 serious adverse events reported to the FDA between March 2013 and March 2014, as documented by the Institute for Safe Medication Practices.
This was 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.
If you or a loved one has been harmed by Invokana, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may reward punitive damages to punish the company and deter similar conduct in the future. If you developed complications after taking Invokana, please speak to us to learn more about your rights.
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 by plaintiffs that live all across the country. This will most likely mean a mass tort consolidation at the Federal level is imminent.
You deserve compensation. It can never replace what you have lost. But, it can help you recover medical expenses, lost wages and the loss of an ability to work. The consultation is completely free, and you are under zero obligation. We are available 24/7 to take your call.