Were you harmed by Invokana?
There is extensive evidence that shows that the type 2 diabetes drug Invokana can cause serious complications. Invokana has clearly been linked to cases of toe, foot, and leg amputations. It has also been linked to kidney failure.
The potential complications from Invokana can be financially and physically devastating. Therefore, it is vital to hire the best Invokana lawyer available for your case. You want to hire a lawyer that gives you the best chance for success. Attorney Cliff Roberts works with an experienced team of experts. They have the resources to fight for you.
Cliff will never charge you a fee unless you get a cash recovery. In addition, your fee will never increase just because you have a great team of experts on your side. Most importantly, Cliff believes that Invokana victims deserve justice. Cliff will seek maximum compensation for your amputation or injuries.
What is Invokana?
Invokana (canagliflozin) is a type 2 diabetes drug that is used to help individuals control high blood sugar. It was first introduced by Johnson & Johnson’s subsidiary Janssen Pharmaceuticals in 2014 as a new class of diabetes drug. Without control, people with high blood sugar do have a risk of kidney damage, nerve issues, blindness, sexual function problems, and limb loss. Common side effects include the following:
- Dry mouth
- Frequent urination
Invokana has been linked to serious problems:
Toe Foot and Leg amputation risks
Reports indicate that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from Johnson & Johnson regarding the risk of lower-limb amputations. If a correlation is discovered that links Invokana to lower-limb amputations, doctors will need to reevaluate the way in which the medication is prescribed.
According to a review by EMA, 7 in every 1,000 people who took Invokana 100-mg for one year experience a toe amputation. This number is in comparison to the 5 in 1,000 taking the 300-mg dose and the 3 in 1,000 whick took a placebo. The studies are based on results from an ongoing clinical trial called Canagliflozin Cardiovascular Assessment Study or CANVAS.
The study is studying roughly 2,000 patients with type 2 diabetes. The groups taking Invokana are showing a higher rate of amputation in the lower limbs.
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) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 5.9 out of every 1,000 patients treated with canagliflozin
- 2.8 out of every 1,000 patients treated with placebo
The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 7.5 out of every 1,000 patients treated with canagliflozin
- 4.2 out of every 1,000 patients treated with placebo
Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.
Renal Impairment and Kidney Failure
In the May 2015, the Institute for Safe Medication Practices (ISMP) warned that Invokana was linked to over 457 serious adverse events in its first 12 months on the market. This included 54 reports of renal impairment or kidney failure.
The manufacturer, Janssen Pharmaceuticals, warns:
- Do not take Invokana if you have severe kidney problems or if you are on dialysis.
- Before you take Invokana, tell your doctor if you have any kidney problems.
- Invokana can cause serious side effects, including kidney problems.
The kidneys are responsible for filtering blood, removing wastes and toxins, and balancing fluid levels. Kidney failure occurs when the filtration system in the kidneys is damaged and stops working.
Select FDA issued warnings
On May 15, 2015, the FDA issued warnings. The warnings mention Invokana and other SGLT2 inhibitors linking to diabetic ketoacidosis. This is also known as DKA, diabetic acidosis, metabolic ketoacidosis or ketoacidosis. Between March 2013 and June 6, 2014, the FDA’s Adverse Events Reporting System, had at least 20 cases of DKA.
On Dec. 4, 2015, the FDA announced new warnings about the products’ labeling about ketoacidosis. The new labels will include information about the side effects. It also includes prescribing and monitoring recommendations for healthcare providers.
Between March 2013 and October 2014, the FDA received 19 reports of patients on SGLT2 inhibitors who developed life-threatening complications of urinary tract infections, such as blood infections (urosepsis) and kidney infections (pyelonephritis). All 19 patients were hospitalized, and some actually needed dialysis to treat kidney failure.
In May 2016, the Food and Drug Administration issued a Safety Labeling Change with warnings and precautions concerning Acute Kidney Injury and Impairment in Renal Function stating the drug causes intravascular volume contraction and can cause renal impairment. The FDA states that there have been post marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving the drug; some reports involved patients younger than 65 years of age.
On May 18, 2016, the Food and Drug Administration issued a drug safety communication informing the public and those in the medical field of the issues involving Invokana and the potential connection with leg, foot, and toe amputations.
The FDA warns patients to be aware of soreness, pain, infections, or ulcers in the feet or legs and to notify their doctors immediately. The FDA has stated that based on ongoing clinical data individuals treated with Invokana are twice as likely to require toe, foot, or leg amputations than those taking a placebo. They urge healthcare providers to report adverse events of amputation while they continue to evaluate the the drug.
The FDA on June 14, 2016 warned about the risk of acute kidney injury with Invokana, Invokamet, Farxiga, Xigduo XR. From March 2013 to October 2015, the FDA received at least 101 reports of of acute kidney injury, Some required emergency hospitalization and dialysis treatment.
On May 16, 2017 based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Invokana users with any of these symptoms should contact their doctor right away. The FDA cautions patients to talk to their doctor first before stopping the medication.
Patients are suing Johnson & Johnson all over the country by way of an Invokana lawsuit. In September 2016, Invokana attorneys asked the Judicial Panel on Multidistrict Litigation to consolidate over 50 individual lawsuits. As a result, the cases have now been consolidated in an MDL in New Jersey.
Most of the lawsuits state the manufacturer failed to warn patients and physicians of the increased risks of serious complications as a result of taking Invokana. Furthermore, if the manufacturer had properly warned, then doctors would have prescribed a medication other than Invokana for patients with type 2 diabetes.
Mitsubishi Tanabe Pharma developed Invokana. Janssen, a division of Johnson & Johnson, marketed Invokana. Accordingly, we believe they should all be held accountable. We also believe they failed to warn patients and doctors about the more serious side effects of Invokana.
The deadline for filing an Invokana claim varies by State. It will depend on the facts of each case. A good Invokana attorney will tell you that If you do not file your claim by the deadline you will lose your right to recover any money at all. Cliff Roberts can tell you the specific deadline in your case.
It is very important that you take action now. Please e-mail us the short case review form. Our evaluation is free and confidential.
Disclaimer: The images on this page of Invokana, product, and/or logo are for informational purposes; this website is neither affiliated with nor sponsored, endorsed, or approved by Janssen Pharmaceuticals, Inc., Johnson & Johnson, Mitsubishi Tanabe Pharma or any other Invokana manufacturers/distributors.
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- You deserve to talk directly with attorney Cliff Roberts within 24 hours of submitting your Free Case Review Form.
- You deserve an attorney that has successfully maintained responsibility for over 1000 injury or death claims.
- You deserve an attorney that will never charge a fee unless a recovery or settlement is reached for you.
- You deserve a persistent and determined attorney with over 25 years experience who is willing to do what it takes for your justice.