The diabetes medication Invokana has been the subject of lawsuits before. However, only recently has new evidence emerged that links the drug to amputation.
In fact, research has shown that Invokana patients are twice as likely to undergo lower-limb amputation [FDA Release] as diabetes sufferers who aren’t taking the drug.
If your Invokana problems included the loss of your toe, foot, or leg, you need to act fast. You have the right to file an Invokana personal injury lawsuit – but that right won’t last forever. Don’t wait to take action.
Invokana Side Effects
The diabetes drug Invokana has risks – some of them deadly. These newest Invokana issues are only the latest in a long list of adverse events and side effects linked to the drug.
The many side effects of Invokana range from the mild to the severe. Some canagliflozin side effects, like a rash, yeast infection, and dizziness, typically only cause discomfort. Others, like kidney damage, bone fractures, ketoacidosis, and pancreatitis, are more serious. At times, these conditions are even life-threatening.
Of course, few Invokana effects are as shocking and drastic as causing you to lose a limb. That’s why the current group of Invokana class action lawsuits involve patients who suffered amputations due to the drug.
Perhaps the most shocking risk of Invokana is limb loss. It’s hard to imagine that a simple tablet that you take by mouth could cause you to lose your leg. Unfortunately, that’s just what the research shows.
Patients who took Invokana to diabetes have ended up needing to undergo amputations of the:
Limb loss survivors face many challenges – not just recovering from the amputation surgery, but as they adjust to life without their limb. Whether you’ve lost a toe, foot, or leg – or perhaps even two – you’ll need to pursue an Invokana amputation lawsuit if you want the money you deserve.
Discovering The Link
It all started with those earlier warnings that Invokana could lead to heart attacks. A clinical trial known as Canagliflozin Cardiovascular Assessment Study (CANVAS) was launched to investigate the risk of major heart-related effects of the drug.
After four and a half years of following patients who took canagliflozin, researchers noticed something disturbing. The patients who took canagliflozin had a far higher rate of amputations than the patients in the control group, who were taking a placebo.
What causes this increased risk of an amputation? The answer isn’t clear just yet. It certainly is disturbing, though, that the drug could put patients who are already vulnerable to serious foot problems at an even greater risk.
In May 2016, the U.S. Food and Drug Administration (FDA) first notified the public of the potential danger.
The clinical trial had shown that patients on the diabetes drug had a greater incidence of amputations. However, the agency then said that it still had “not determined whether canagliflozin increases the risk of leg and foot amputations.”
Over the next year, the FDA continued to investigate. Meanwhile, patients who hadn’t heard the news of a potential link continued to remain at risk and uninformed. Invokana labels still contained no mention of the possibility of an increased danger of limb loss.
By May 2017, things had changed. A second clinical trial had confirmed the findings of the initial CANVAS researchers. The FDA announced that it would now require Invokana to have a black box warning – its strictest warning – notifying patients of the amputation risk.
- In the CANVAS clinical trial, 9 out of every 1,000 patients taking the drug had to have an amputation, compared to just 2.8 out of every 1,000 patients taking a placebo.
- The second clinical trial showed a similar risk increase. Here, 5 out of every 1,000 patients on canagliflozin underwent an amputation, compared to 4.2 out of every 1,000 patients in the control group.
Invokana’s new warnings may help future patients avoid amputation, but for many patients, it’s too late. They have already lost a limb. The new FDA alert does nothing to help them cope with the problems they’re now facing.
This isn’t the first time, in the short time Invokana has been on the market, that the diabetes drug has led to legal claims.
From the start, the FDA – and even the members of the advisory panel that voted to approve the drug – worried about “potentially serious side effects,” according to The New York Times.
In the year that followed the drug’s approval, the FDA received hundreds of reports of adverse events, the Institute of Safe Medication Practices reported.
Most Invokana injury lawsuits have resulted from the drug’s role in causing kidney damage, heart disease, and a life-threatening condition called diabetic ketoacidosis.
Recently, several national firms have brought claims alleging that their clients had to undergo amputation as a result of taking Invokana.
Many of the Invokana claims against Johnson & Johnson are class action lawsuits. A class action claim involves a group – or “class” – of people who suffered similar kinds of harm from the same cause. This is different than a personal injury claim, which typically only involves a single claimant.
When you’ve suffered serious harm from Invokana, Johnson & Johnson should be facing the consequences – not you.
Yet so far, you’re the one who has suffered pain and disability. You’re the one who has racked up tens of thousands of dollars in medical bills – and you could be looking at hundreds of thousands of dollars in medical costs over a lifetime. This drug has caused you to lose an irreplaceable part of your body, not to mention all of the functioning that went with it.
Meanwhile, the manufacturer of the Invokana medicine is still raking in hundreds of millions of dollars in profits.
This isn’t fair.
You deserve full accountability from Johnson & Johnson. More importantly, you deserve compensation for all of the harm you have suffered and all of the things that you can no longer do. Nothing can replace your missing limb, but filing a claim for the damages that came from your amputation can help you adjust to life after losing a limb.
What Is Invokana?
The medication Invokana is part of the drug class gliflozin. Drugs in this class are also known as a subtype 2 sodium-glucose transport (SGLT2) inhibitors.
What Invokana is used for is the treatment of type 2 diabetes. Basically, the drug can help patients with type 2 diabetes regulate blood sugar and keep it from getting too high.
Due to the way it works, Invokana shouldn’t be used to treat type 1 diabetes. These two conditions are both metabolic diseases in which patients have high levels of blood sugar, but they have different causes.
Invokana by Other Names
Invokana is the brand name for the drug known generically as canagliflozin.
Who Makes Invokana?
Invokana’s manufacturer is Janssen Pharmaceuticals, a division of Johnson & Johnson (J&J).
The company also sells a version of the drug called Invokamet. This drug combines canagliflozin with metformin, another drug used to treat diabetes.
The canagliflozin present in Invokamet could cause the same amputation risk increase as Invokana. If you think this drug played a role in your limb loss, you should talk to an Invokamet injury attorney to learn more about your rights.
Though Invokana has only been on the market since 2013, it’s been a popular seller for J&J. The drug brought in $1,273,000,000 in sales in 2016, Johnson & Johnson reported in a press release.
How Does Invokana Work?
Invokana treatment helps patients with type 2 diabetes control their blood sugar.
Understanding Type 2 Diabetes
In patients with type 2 diabetes, the body has a hard time making or using a hormone called insulin. Insulin helps your body use glucose, or sugar, effectively.
When you don’t have enough insulin, the glucose that should be powering your cells instead remains in your blood at high levels. The problem with having blood sugar levels that are too high is that, over time, you can develop damage to many different body parts.
According to the U.S. National Library of Medicine, high blood sugar levels can harm your:
The Invokana Mechanism of Action
Invokana is a SGLT2 inhibitor. What it inhibits is a process called renal glucose reabsorption.
Within the body, the kidneys work to filter and clean your blood. They convert the waste, chemicals, and extra fluids from your blood into urine. A protein found in the body called sodium-glucose transport protein 2 causes the kidneys to reabsorb glucose rather than filter it out into the urine.
For people with a healthy blood sugar level, this isn’t a problem. The body will convert the glucose to energy. If you have type 2 diabetes, though, your blood sugar levels remain high. This puts various systems within your body at risk.
SGLT2 inhibitors like Invokana stop that sodium-glucose transport protein 2 from helping the kidneys to reabsorb glucose. As a result, your kidneys can remove more of your excess blood sugar through urine. That glucose doesn’t remain in your blood, damaging your body.
What’s the Problem With Invokana?
When you take J&J’s Invokana tablets, you expect the drug to help you control your blood sugar levels. It should help you manage your diabetes – not make you more prone to serious conditions like limb damage too severe to salvage.
Drugs Like Invokana
Canagliflozin is just one type of SGLT2 inhibitor. Other diabetes drugs that work in similar ways include:
- Farxiga (dapagliflozin)
- Jardiance (empagliflozin)
So far, research has proven only that canagliflozin is linked to an increased amputation risk. Invokana alternatives like Farxiga and Jardiance might not pose the same danger.
However, a panel of experts with the European Medicines Agency is investigating whether all SGLT2 inhibitors raise patients’ amputation risk. In the meantime, the agency is requiring the European labels of all SGLT2 inhibitors – not just Invokana – to warn patients of a potential increase in amputation risk, Medscape reported.
Farxiga and Jardiance have already been linked to many of the same complications as Invokana, such as kidney problems and diabetic ketoacidosis. If researchers find that these drugs, too, increase the chance of amputation, then Farxiga lawsuits could soon become just as common as Invokana lawsuits.