If you or a loved one were prescribed and took Invokana® (canagliflozin) and then suffered kidney or heart-related side effects, you may be entitled to compensation.
May 23, 2017 - The U.S. FDA has determined that taking Invokana or Invokamet (canagliflozin metformin) can double the risk of foot and leg amputation in diabetes patients. Issuing a "boxed warning," the FDA will require manufacturers of Invokana to prominently display this warning on the drug's packaging. A boxed warning is the strongest warning the FDA requires, indicating severe or life-threatening effects. Read more about the diabetes drug being linked to amputation risk.
Invokana, marketed by Janssen Pharmaceutica, is a drug commonly prescribed to aid in treating high blood sugar (A1C) in people with type 2 diabetes. The lawsuits claim that doctors would have prescribed other drugs or treatments had they been made aware of the severity of heart and kidney side effects, including, but not limited to:
- Heart attacks
- Kidney disease
If this describes you or a loved one, the Kishish Law Group can help. Contact us today for a free and confidential case evaluation by using our contact form or calling us at 1 (888) 609-4664 .
The U.S. F.D.A. warns consumers about Invokana
The U.S. Food and Drug Administration (F.D.A.) approved Invokana in 2013 as the first in a class of drugs called SGLT2 inhibitors. SGLT2 is a transporter protein that aids the kidneys in retention of glucose. By inhibiting this protein, Invokana and other similar drugs cause more blood sugar to be lost during urination, helping patients control their blood sugar levels.
In 2015, the F.D.A. published a safety announcement warning consumers of Invokana about the risk for a condition called ketoacidosis. During ketoacidosis, a lack of glucose absorption causes the body to over-produce ketone bodies leading to dangerous conditions that can require hospitalization. Symptoms of ketoacidosis include:
- Difficulty breathing
- Abdominal pain
Nearly seven months later, in December 2015, the F.D.A. issued another warning about Invokana and other SGLT2 inhibitors. At the time of this warning, the F.D.A. had identified 73 patients who had taken SGLT2 inhibitors and then developed ketoacidosis. All of these patients required emergency treatment or hospitalization. Additionally the F.D.A. reported cases where patients taking SGLT2 inhibitors had developed serious urinary tract infections resulting in kidney infections and life-threatening blood infections. In some of these cases, patients required dialysis to treat kidney failure.
In May 2016, the F.D.A. added additional warnings about Invokana, this time reporting that clinical trials had found an increased risk for amputation of legs and feet. Although the F.D.A. acknowledged that the trial was not definitive, they still warned users of the drug to monitor themselves for "new pain or tenderness, sores or ulcers, or infections in their legs or feet." One month later, the F.D.A. revised the labels for Invokana and other similar drugs to include warnings about acute kidney injury.
Do I have an Invokana lawsuit?
The Kishish Law Group is committed to seeking justice for you and your loved ones. We believe that you deserve fair compensation for your suffering and we will work tirelessly to achieve that goal. If you or a loved one suffered due to taking Invokana, we want to know.
Further Breakdown of The Invokana Lawsuit
Invokana Lawsuit: The What
Invokana has been marketed as a prescription medicine utilized in combination with frequent exercise and a healthy diet to combat high blood sugar and ultimately improve the glycemic load in adults with Type 2 diabetes. The drug performs this by artificially lowering blood sugar levels, allowing the kidneys to remove the excess sugar through the urine.
Those who have Type 2 diabetes often find themselves at increasing resistance to insulin’s effects. As the cells become unable to use the sugar injected from insulin, the sugar begins backing up in the blood stream, causing hyperglycemia in extreme but common situations. The majority of anti-diabetic medicine acts by reducing sugar levels while simultaneously increasing the effectivity of insulin in the bloodstream. SGLT-2 inhibitors (such as Invokana) blocks reabsorption of glucose from the kidneys. What this means is that the glucose that gets to the kidneys does not filter back to the bloodstream.
Invokana Lawsuit: The Why
There have been many side effects listed as a result of Invokana’s utilization in Type 2 diabetics. The most dangerous four from the list are ketoacidosis, amputations, kidney failure, and myocardial infarctions (heart attacks).
Kidney failure takes place when the organs cease functioning without a transplant or dialysis regimen. When kidney function terminates, fluids, waste, and electrolytes build up in the bloodstream, which causes lethargy, weakness, shortness of breath, heart arrhythmias, confusion, and in some more severe cases death.
Ketoacidosis is caused when extremely high levels of ketones are produced inside the body. It grows and becomes more critical when abnormal insulin levels are presented, as, without adequate insulin levels, the body begins to break down fat, causing further rapidity of ketone production. This severe medical issue can lead to extended periods of hospitalization, diabetic comas, or in more serious cases death.
Advanced clinical trials have also revealed that Invokana users are more than twice as likely to suffer diabetes-related amputations as those taking a placebo medication. Also, heart attacks have become more prevalent in Invokana users. This occurs when an arterial blockage prevents blood from reaching the heart, starving the organ of nutrients and oxygen, and causing cardiac ischemia, leading to the death of the affected heart tissue and an eventual myocardial infarction (heart attack).
It has been argued by attorneys for the Invokana class action lawsuit that, had the manufacturer adequately warned users of the medication, physicians would have chosen alternative treatment options for diabetic patients. It was also argued that if the warnings had been made clear to people with diabetes that had been on Invokana, health monitoring would have been sufficiently amplified to allow for greater combatting of common side effects and complications.
Additionally, a 2015 study performed by the Food and Drug Administration caused Invokana labeling to be pulled, and the product be re-labeled to warn about increased risk of bone-related fracturing. Extended clinical work showed increased occurrences of bone fractures present as soon as three months after initial Invokana treatment. Invokana was subsequently linked to bone mineral density problems in the hip area, which in more extreme cases caused hip fractures from minor incidences of trauma.
Invokana Lawsuit: The Who
It is vital for those currently on Invokana to note any signs of any of the following side effects:
- Kidney failure
- Heart-related issues
- Sores or infections on the lower extremities
- Ketoacidosis, or any other form of acidosis
It is also extremely important for Invokana patients to seek medical attention when experiencing any negative side effects mentioned above, also including but not limited to shortness of breath or hyperventilation, increased heart or pulmonary rate, faint feelings or dizziness/vertigo, or general weakness. Physical side effects have also included persistent issues such as abdominal pain, general confusion, urinary changes, nausea and vomiting, anorexia, and extended periods of sleepiness and fatigue.
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Speak with an Invokana Lawyer
If you or a loved one were prescribed and took Invokana (canagliflozin) and suffered injuries or serious side effects, you may be entitled to compensation.
Contact a lawyer today for a free and confidential legal consultation.
- February 18, 2018
Invokana Lawsuits Rise, First Trial of Alleged Amputation Set for September
- June 12, 2017
Invokana Side Effects and Diabetic Ketoacidosis
- June 8, 2017
SGLT2 Inhibitors, like Invokana, Found to Double Risk of Diabetic Ketoacidosis
- May 23, 2017
Diabetes Drug Invokana Linked to Amputation Risk
- May 17, 2017
Over 30% of Drugs Had Safety Problems After FDA Approval