Category Archives: Urinary Tract Infection

Kidney Failure, Other Problems Lead to Invokana Lawsuit in Tennessee

Invokana and Kidney Problems

In his complaint, Wardell Fleming indicates that he was prescribed Invokana in November 2013, to treat his diabetes and help control his blood sugar. As a result of his Invokana treatment, Fleming alleges, he developed serious kidney problems, including kidney failure, kidney damage, and reduced kidney function, and is now at an increased risk of stroke, heart attack and diabetic ketoacidosis (DKA) as a result of taking the Type 2 diabetes medication. “SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose,” the lawsuit states. “As a result, excess glucose is not metabolized, but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease.”

FDA Warnings for Invokana Users

Allegations raised in Fleming’s lawsuit mirror concerns raised by the U.S. Food and Drug Administration (FDA), which issued a new drug safety communication on December 4, warning that Invokana and other SGLT2 (sodium-glucose cotransporter-2) inhibitors may increase the risk of diabetic ketoacidosis and serious urinary tract infections. According to the warning, the agency identified “19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

Alleged Side Effects of SGLT2 Inhibitors

Both the FDA and the Institute for Safe Medication Practices (ISMP) have raised serious concerns about the alleged side effects of Invokana and other SGLT2 inhibitors, which may include kidney failure, kidney damage, diabetic ketoacidosis, urinary tract infections, kidney stones, dehydration, hypersensitivity and abnormal weight loss. In fact, the ISMP examined the adverse event reports submitted to the FDA and found that Invokana (canagliflozin) was associated with more adverse events than 92% of the other medications regularly monitored by the organization.

Invokana Makers Accused of Failure to Warn

Like Fleming, former Invokana users across the country are now pursuing legal claims against Johnson & Johnson and Janssen Pharmaceuticals, alleging that the drug makers knew or should have known about the potential for Invokana users to suffer kidney injuries and other serious complications. According to Fleming’s complaint, “The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information, revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”

Contact an Experienced Invokana Lawyer Today

In its December safety warning, the FDA announced new warnings for the labels of SGLT2 inhibitors like Invokana, highlighting the risk of diabetic ketoacidosis, urinary tract infections, kidney infections and kidney failure that may result from treatment with the diabetes drugs. If you or a loved one has suffered kidney failure, kidney damage, diabetic ketoacidosis, or another serious side effect allegedly associated with Invokana treatment, you may be entitled to financial compensation for your injuries. Contact a knowledgeable Invokana attorney as soon as possible to discuss your legal options.

Side Effects of Type 2 Diabetes Drugs May Outweigh Benefits

FDA Warns of Potential Invokana Side Effects

In a new drug safety communication issued by the U.S. Food and Drug Administration (FDA) on December 4, the agency indicates that an FDA safety review has “resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risk of too much acid in the blood and of serious urinary tract infections.” The FDA also warns in the new health advisory that both of these conditions can result in hospitalization, and that “patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.”

What is Diabetic Ketoacidosis?

Diabetic ketoacidosis is a serious medical condition that occurs when the cells don’t get the glucose they need for energy and begin burning fat for fuel instead, which produces blood acids called ketones. When ketones build up in the body, they make the blood more acidic and can actually poison the body. When levels of ketones in the blood get too high, the patient may develop diabetic ketoacidosis, which can lead to serious complications, like diabetic coma or even death. Other possible side effects of Invokana and similar SGLT2 inhibitor medications like Farxiga and Jardiance include heart attack, kidney damage and kidney failure.

FDA Warnings for Invokana Users

This latest FDA warning comes on the heels of a drug safety communication issued by the FDA in March 2015, which warned that “the type 2 diabetes medicines canagliflozin [Invokana], dapagliflozin [Farxiga] and empagliflozin [Jardiance] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.” At that time, the FDA had identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis or ketosis in patients treated with SGLT2 inhibitors like Invokana between March 2013 and June 6, 2014.

In its new advisory, the FDA warns of 73 cases of ketoacidosis the agency identified in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors from March 2013 to March 2015. The agency also warns in its latest safety communication about the risk of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors.” According to the FDA, of the 19 cases of infections identified in connection with the use of the diabetes drugs, “all 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

A Qualified Invokana Lawyer Can Help

If you believe you have been adversely affected by alleged Invokana side effects like ketoacidosis, kidney failure, a blood infection or a kidney infection, consult an experienced product liability lawyer today for legal help. With a knowledgeable Invokana attorney on your side, you can ensure that your legal rights are protected and seek fair and timely reimbursement for your losses.

Diabetes medications linked to deadly side effects Diabetic Ketoacidosis (DKA), Kidney Failure, Heart Attack, and Stroke

What are SGLT2 Inhibitors and what are the risks associated with their use?

SGLT2 inhibitors are also known as gliflozins. They lead to a reduction in blood glucose levels. Therefore, SGLT2 inhibitors have potential use in the treatment of type II diabetes. As studied on Invokana (canagliflozin), a member of this class of drugs, gliflozins enhance glycemic control as well as reduce body weight and systolic and diastolic blood pressure. There are however serious concerns. The gliflozins canagliflozin, dapagliflozin, and empagliflozin have been linked to diabetic ketoacidosis or DKA, a condition where acid levels in the blood become dangerously high.

Warning signs of ketoacidosis (DKA) include vomiting, nausea, trouble breathing, general confusion, abdominal and intestinal pains and severe fatigue. The FDA has urged patients who are taking any of the aforementioned diabetes medications and are suffering from any of these symptoms to seek medical attention immediately.

Additional side effects of gliflozins allegedly include increased risk of kidney failure and other kidney injuries, heart attack, stroke, osteoporosis, urinary tract infections, candidal vulvovaginitis and hypoglycemia.

Dangerous Side Effects Linked to SGLT2 Inhibitor Diabetes Medications

Diabetic Ketoacidosis also known as DKA or Ketoacidosis is a condition in which high levels of ketones (chemicals that the body creates when it breaks down fat to use for energy) are produced in the body. Ketoacidosis is a condition that can result in a patient suffering diabetic coma, extended hospitalization and even death. Ketoacidosis develops when the body is unable to produce enough insulin, which insulin plays a major role in helping sugar (glucose) enter cells, and provides needed energy to the muscles and other tissues. Without enough insulin, the body breaks down fat as an alternative source of energy. This process produces a buildup of toxic acids in the bloodstream, ketones.

Kidney failure occurs when your kidneys stop functioning without the use of dialysis or a kidney transplant. Kidneys help filter waste products from the blood. They are also involved in regulating blood pressure, red blood cell production and electrolyte balance. If your kidneys fail to function properly, waste products, electrolytes and other fluids can build up in the body and can cause weakness, shortness of breath, fatigue, confusion, abnormal heart rhythms and death.

Myocardial infarction (MI) or acute myocardial infarction (AMI), commonly known as a heart attack, occurs when blood flow stops to a part of the heart causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may travel into the shoulder, arm, back, neck, or jaw. Often it is in the center or left side of the chest and lasts for more than a few minutes.

Why are we filing Diabetes Medication Lawsuits against the manufactures of drugs like Invokana, Jardiance, Xigduo, Invokamet, and Glyxambi?

The diabetes medication lawsuits allege that the manufacturers and marketers of SGLT2 inhibitors (including as Johnson & Johnson, Janssen Pharmaceuticals Inc., AstraZeneca, etc.) failed to adequately research their drugs in clinical studies and that they did not warn physicians or patients of the increased risk of diabetic ketoacidosis (DKA), kidney failure, heart attack, stroke, and other dangerous side effects. The lawsuits allege that if the manufacturers and marketers of these drugs had properly warned patients and doctors of the risks, there is a strong likelihood that doctors would have been more reluctant to prescribe the drugs, and that many of the patients would have been chosen a less dangerous alternative to treat their diabetes, and that they would likely have had relevant symptoms monitored on a more regular basis for potential signs of increased levels of ketones, heart concerns, and kidney impairment.

How to file a lawsuit if you or a loved one have suffered an injury after taking a diabetes medication

If you or a loved one have been prescribed one of the diabetes medications above and have suffered from a dangerous side effect such as diabetic ketoacidosis, kidney failure, heart attack or stroke, it is highly recommended that you contact an attorney as soon as possible. A lawsuit can be filed on your behalf at no cost to you or your family unless there is a settlement or verdict in your favor. Call right now at 888-323-9935 or complete the form at http://invokana.attorney/ and one of our attorneys will get back to you right away to discuss your case at no cost.

FDA Adds New Ketoacidosis, Urinary Tract Infection Warnings to Diabetes Drug Labels

FDA Warnings for Invokana Users

This new SGLT2 inhibitor warning comes on the heels of a drug safety communication issued by the FDA in May 2015, which included information about the potential for the Type 2 diabetes drugs to cause diabetic ketoacidosis, a condition characterized by too much acid in the blood. A growing body of research has linked the use of Invokana and other popular SGLT2 inhibitors to an increased risk of diabetic ketoacidosis (DKA), which is characterized by symptoms like nausea, vomiting, tiredness, abdominal pain and difficulty breathing. Diabetic ketoacidosis is a medical emergency, and without treatment, the condition may result in diabetic coma and death.

As the FDA’s December 2015 warning states, “A review of the FDA Adverse Event Reporting System database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors.” The FDA also identified “19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported […] from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

Alleged Side Effects of SGLT2 Inhibitors

In light of these potential complications, the FDA has added new Warnings and Precautions to the labels of all SGLT2 inhibitor drugs, including Invokana (canagliflozin), Farxiga (dapagliflozin), Invokamet (canagliflozin/metformin), Glyxambi (empagliflozin/linagliptin), Xigduo XR (dapagliflozin/metformin) and Jardiance (empagliflozin), describing the risk of serious urinary tract infections and ketoacidosis side effects in users. The agency is also requiring the makers of SGLT2 inhibitors to conduct post-marketing research to analyze reports of diabetic ketoacidosis complications in patients treated with SGLT2 inhibitors, including specialized follow-up for a period of five years.

SGLT2 inhibitors like Invokana are Type 2 diabetes medications designed to work by causing glucose to be excreted in the urine, thereby lowering glucose levels in the bloodstream. However, the medications have been linked to an increased risk of diabetic ketoacidosis, kidney failure, heart attack, cardiovascular problems, abnormal weight loss, allergic reactions, wrongful death, and now serious urinary tract infections as well. According to the FDA, the 19 cases of serious urinary tract infections only occurred in patients treated with Invokana or Farxiga, but the agency did not indicate that Jardiance and other SGLT2 inhibitors are free of such a risk.

Contact a Reputable Invokana Attorney Today

According to the FDA’s new Invokana side effect warning, “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis,” and “Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms.” If you took Invokana or another similar Type 2 diabetes drug, and you have since suffered diabetic ketoacidosis, a urinary tract infection, or another serious medical complication, contact a knowledgeable product liability lawyer today to explore your possible compensation options.