Invokana Side Effects Litigation
Loncar Associates is shifting litigation focus from kidney injuries to amputation cases.
Diabetes has been described as an epidemic in the United States. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and a range of problems. Diabetes is the seventh leading cause of death in the U.S. and billions are spent every year by insurers and federal, state and local governments to treat diabetics.
In diabetics, big pharmaceutical manufacturers see an enormous opportunity to profit off of a disease that forces millions of Americans to rely on medication to treat their condition. In their rush to get the next best drug on the market manufacturers often miss, overlook, ignore or even cover-up dangerous side effects of their medications. Manufacturers have routinely been accused of adding side-effects on their labeling to confuse and desensitize consumers in an effort to subvert the whole labeling process.
Federal and state laws require pharmaceutical manufacturers to properly warn consumers and physicians of the side-effects of their medications. When manufacturers fail to disclose the dangerous side-effects of their products and consumers experience devastating, often catastrophic injuries, product liability litigation should be strongly considered. Since 1999, thousands of Americans injured by defective medical devices and dangerous drugs have trusted Loncar & Associates to get them the justice and compensation they deserve.
Invokana’s checkered past
First available for consumption in the United States on March 29, 2013, Invokana (canagliflozin) was approved by the FDA for use by diabetics to work with the kidneys in order to lower a patient’s blood sugar. Invokana is a SGLT2 inhibitor. When used in combination with diet and exercise it is designed to lower blood sugar in adults with type 2 diabetes by allowing excess sugar to pass in urine. There are a large number of medications approved by the FDA that are designed to keep a diabetic’s blood sugar in the normal range when combined with a healthy diet and regular exercise. The fact that Invokana may do that too, does not make it special. In fact, there is no evidence that Invokana does anything special – it doesn’t control blood sugar any better than other medications (it provided only modest improvement in control of A1C compared to placebo) and there was no evidence of improved outcomes in survivability or reduction in diabetic complications.
In just under five years on the market, the medication has been plagued with problems.
By May of 2015, the number of adverse events associated with the use of SGLT 2 inhibitors was significant enough that the FDA alerted prescribers and users of severe side effects such as acute kidney failure and ketoacidosis. On May 15, 2015 the FDA required the manufacturer to add serious urinary tract infections, acute kidney failure and ketoacidosis to the Invokana warning label. On June 14, 2016 the FDA decided to strengthen the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines Invokana and Invokamet, among others. Based on injury reports, the FDA revised the warnings in the drug labels to include information about acute kidney failure and ketoacidosis and added recommendations to minimize this risk. Acute kidney failure and ketoacidosis are serious medical emergencies that can cause a lifetime of medical problems, even death. Onset is often seen early after switching to an SGLT2 inhibitor like Invokana; although these conditions can occur at any time.
Some Invokana kidney injury cases are quietly settling out-of-court. If you were diagnosed with acute kidney failure or ketoacidosis while using or shortly after using Invokana, contact our office immediately. It may already be too late for our office to assist clients with these claims – contact us immediately if you wish to discuss Invokana kidney injury litigation.
Invokana linked to amputations
On May 18, 2016 the U.S. Food and Drug Administration (FDA) alerted the public to interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations in patients treated with diabetes medications containing canagliflozin (Invokana, Invokamet). In the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial, the trial’s independent data monitoring committee (IDMC) identified an increased risk of leg and foot amputations. The data shows amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with a placebo (an inactive treatment).
Black Box Warning – Amputations
By May 16, 2017 the FDA required Janssen Pharmaceuticals, Inc to issue a boxed warning to consumers and physicians alerting them to the increased risk of toe, foot and leg amputations caused by use of Invokana and Invokamet. A Black Box warning appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. A black box warning is the highest level of alert that the FDA will issue short before it recalls a medication.
Loncar & Associates is currently focusing its efforts on litigation against Janssen Pharmaceuticals, Inc. on behalf of Invokana users who suffered amputations of the toes, feet or legs during or after Invokana use. The law limits the time in which litigation can be pursued so while it may be too late to pursue litigation for patients who suffered significant kidney injuries, if you suffered an amputation injury, there is still time to pursue your case. These are not medical malpractice suits and this is not class action litigation. Contact us immediately to discuss your rights. An initial consultation takes only a few minutes with no obligation or cost to you.
The updated labeling information announced on May 16, 2017 impacts your right to compensation. If you used Invokana anytime prior to May of 2017 and have suffered an amputation of the toes, feet or legs since, you need an attorney experienced in pharmaceutical litigation immediately. Since 1999, the law offices of Loncar & Associates has been a pioneer in pharmaceutical and medical litigation, successfully representing victims of big pharma. Don’t let the opportunity to seek justice pass you by.
We pursue individual lawsuits, not class actions. You don’t have to sue your doctor. Complete the contact form or call Loncar & Associates immediately at 800.285.4878 to discuss your legal options.