Category Archives: News

J&J’s Potentially Dangerous Invokana Diabetes Drug a Billion-Dollar Blockbuster

Diabetic Ketoacidosis, Kidney Failure, News

Potential Side Effects of Invokana

When Invokana (canagliflozin) was approved by the U.S. Food and Drug Administration (FDA) in 2013, the medication was marketed by Johnson & Johnson as a safe and effective means of lowering blood glucose levels in adults with Type 2 diabetes. The drug achieves this by inhibiting the reabsorption of glucose in the bloodstream, thereby increasing the amount of glucose that is excreted through the urine. Because of its solid performance in early clinical trials, Invokana quickly became one of the most widely-used diabetes medications on the market, with drug sales increasing dramatically from $586 million in 2014 to $1.3 billion in 2015.

Even as more and more diabetes patients are switched to Invokana therapy, a growing number of studies are highlighting the potential for Invokana treatment to cause serious side effects in users. According to research, patients with Type 2 diabetes who take Invokana may have a significantly increased risk of suffering devastating complications like diabetic ketoacidosis (DKA), kidney failure, kidney damage, urinary tract infections, heart attack, cardiovascular problems and wrongful death. During drug trials conducted before Invokana was approved by the FDA, animal studies linked Invokana use to a higher risk of fungal infections, kidney damage, abnormalities in the bones, and testicular and kidney cancers.

FDA Warnings for Invokana Users

In its first warning about the potential side effects of Invokana, issued in May 2015, the FDA warned that “the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin 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 indicated that it had received reports of 20 cases of acidosis identified as diabetic ketoacidosis, ketoacidosis or ketosis in patients treated with SGLT2 inhibitors like Invokana from March 2013 to June 6, 2014. In September 2015, the FDA issued another warning indicating that patients taking Invokana may face an increased risk of bone fractures and bone mineral density loss.

In an updated warning issued in December 2015, the FDA identified 73 cases of ketoacidosis in patients treated with SGLT2 inhibitors from March 2013 to May 2015. In that same safety communication, 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 to FAERS from March 2013 to October 2014.” Despite these serious risks, Johnson & Johnson continues to market Invokana as a safe and effective way for patients with Type 2 diabetes to lower their blood glucose levels.

A Qualified Invokana Attorney Can Help

Contact a knowledgeable product liability lawyer today if you believe you have been adversely affected by side effects of Invokana. You may be entitled to reimbursement for your injuries, which you can pursue by filing an Invokana lawsuit against Johnson & Johnson.

The Latest News on Invokana and Diabetic Ketoacidosis

Diabetic Ketoacidosis, Heart Attack, Kidney Failure, News, Stroke

Possible Ketoacidosis Side Effects of Invokana

Invokana (canagliflozin) belongs to class of Type 2 diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which are designed to be used in combination with diet and exercise to help control blood sugar levels in adults with Type 2 diabetes. Manufactured by Johnson & Johnson’s Janssen Pharmaceuticals unit and approved by the FDA in March 2013, Invokana has since become one of the best-selling diabetes drugs on the market in the U.S., generating more than $270 million in sales during the first quarter of 2015. However, the use of SGLT2 inhibitors like Invokana has been tied recently to an alleged increased risk of diabetic ketoacidosis, a serious medical condition that can lead to respiratory distress, kidney failure, coma and death.

Invokana Warnings from the FDA

Although Invokana has been on the market in the U.S. since 2013, reports about the potential risk of ketoacidosis from the diabetes drug are relatively new. In a drug safety communication issued by the FDA in May 2015, the agency reports 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.” Just two months after the FDA issued its SGLT2 inhibitor warning, Health Canada announced that it would be launching an investigation into the safety of Invokana and similar drugs, due to “international reports of ketoacidosis with the use of SGLT2 inhibitors in patients with Type 2 diabetes.”

Lawsuits Over Invokana Ketoacidosis Injuries

With numerous studies and FDA warnings highlighting the alleged risk of diabetic ketoacidosis from SGLT2 inhibitors like Invokana, product liability lawyers across the country are investigating claims on behalf of consumers who believe they have been harmed by side effects of the diabetes medications. Because Invokana is a relatively new medication, many consumers currently taking the drug to treat Type 2 diabetes may be unaware of the potential connection between the treatment and diabetic ketoacidosis side effects. As researchers continue to examine this alleged link, product liability claims are expected to be brought against Janssen Pharmaceuticals and other SGLT2 inhibitor manufacturers in the coming months and years.

Contact an Experienced Invokana Attorney Today

Diabetic ketoacidosis is a potentially life-threatening medication complication that can lead to death if left untreated. Unfortunately, because the alleged link between SGLT2 drugs like Invokana and ketoacidosis side effects was withheld from consumers and the medical community until just recently, diabetes patients across the country have continued using the drug, unaware that it may be causing their ketoacidosis injuries. If you took Invokana or another SGLT2 inhibitor drug in the past, and you have since suffered a serious medical complication like diabetic ketoacidosis, contact a knowledgeable drug injury lawyer today for legal help. You may have grounds to file an Invokana lawsuit against Janssen Pharmaceuticals, in order to seek fair and timely reimbursement for your injuries.

Kidney Failure, Other Problems Lead to Invokana Lawsuit in Tennessee

Diabetic Ketoacidosis, Heart Attack, Kidney Failure, News, Stroke, Urinary Tract Infection

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.

Invokana Lawsuit Filed Over Risk of Diabetic Ketoacidosis Injuries

Diabetic Ketoacidosis, News

Possible Side Effects of SGLT2 inhibitors

This latest Invokana lawsuit was filed in the Philadelphia Court of Common Pleas, and includes allegations that Invokana maker Janssen Pharmaceuticals and its parent company, Johnson & Johnson, knew that the Type 2 diabetes drug could cause diabetic ketoacidosis in users, but failed to warn doctors and consumers of this risk. The case joins a growing number of product liability lawsuits filed over DKA and other alleged side effects of Invokana, which may include heart attack, abnormal weight loss, urinary tract infections, cardiovascular problems, kidney damage, kidney failure or wrongful death.

New FDA Warning for Invokana Users

The most recent warning about a risk of diabetic ketoacidosis from Invokana was issued by the FDA on December 4, and indicated a change to the labels of SGLT2 inhibitors like Invokana, to reflect the risk of ketoacidosis and serious urinary tract infections associated with the drugs, both of which can result in hospitalization. According to the FDA warning, “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis,” which may include nausea, vomiting, fatigue, abdominal pain or difficulty breathing.

In its latest warning, the FDA stated that the agency had identified 73 cases of ketoacidosis in patients with Type 1 or Type 2 diabetes treated with SGLT2 inhibitors like Invokana between March 2013 and May 2015, all of which resulted in hospitalization or treatment in an emergency room. The agency also linked the use of SGLT2 inhibitors to 19 cases of life-threatening blood infections and kidney infections that began as urinary tract infections between March 2013 and October 2014, all of which resulted in hospitalization, with a few admissions to an intensive care unit or dialysis center for kidney failure treatment.

SGLT2 Inhibitors Linked to DKA Side Effects

The FDA’s December warning followed a previous safety communication issued in May 2015, in which the agency indicated that “the type 2 medicines [Invokana], [Farxiga] and [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 Invokana or another SGLT2 inhibitor from March 2013 to June 6, 2014, all of which resulted in hospitalization to treat the ketoacidosis.

An Experienced Invokana Attorney Can Help

As more and more former Invokana users become aware of the potential for the Type 2 diabetes medication to cause diabetic ketoacidosis and other devastating side effects in users, a growing number of individuals are pursuing legal claims against Janssen Pharmaceuticals for damages including medical bills, lost wages, and pain and suffering. If you took Invokana or another SGLT2 inhibitor in the past, and you have since been diagnosed with diabetic ketoacidosis, ketoacidosis or ketosis, contact a knowledgeable product liability lawyer today to explore your possible compensation options.

Symptoms of Diabetic Ketoacidosis

Diabetic Ketoacidosis, Invokana Symptoms, News

Warning Signs of Diabetic Ketoacidosis

When cells don’t have enough insulin to use the glucose they need for energy, the body will begin to burn fat for fuel instead, which produces blood acids called ketones. When there are high levels of ketones in the blood, the blood becomes more acidic and complications like diabetic ketoacidosis may occur. Diabetic ketoacidosis usually develops gradually. However, when vomiting occurs, the condition can progress in just a few hours, resulting in symptoms like:

  • Frequent urination
  • Thirst or dry mouth
  • High levels of ketones in the urine
  • High blood glucose levels
  • Dry or flushed skin
  • Constantly feeling tired
  • Difficulty breathing
  • Nausea, vomiting or abdominal pain
  • Confusion

Who is at Risk for DKA Side Effects?

Diabetic ketoacidosis is typically triggered by a problem with insulin therapy, or an illness, like pneumonia, which can work against the effect of insulin or leave the body with too little insulin to work the way it’s supposed to. Some other possible causes of diabetic ketoacidosis include alcohol or drug abuse, heart attack, or physical or emotional trauma, and a growing number of studies have shown that patients who take Invokana or another Type 2 diabetes medication belonging to the SGLT2 inhibitor class of drugs may also be more likely to develop diabetic ketoacidosis side effects.

Invokana and other SGLT2 inhibitor medications are designed to help improve glycemic control in adults with Type 2 diabetes, and the drugs lower blood glucose levels by preventing sugar from being reabsorbed into the blood by the kidneys, and by promoting the excretion of glucose through the urine. However, in May 2015, the U.S. Food and Drug Administration (FDA) issued a warning indicating 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.”

Ketoacidosis Treatment and Complications

Diabetic ketoacidosis is a medical emergency, and individuals diagnosed with the condition may be treated in the emergency room or admitted to a hospital for treatment, which usually involves fluid replacement, insulin therapy and/or electrolyte replacement. In its 2015 safety announcement, the FDA identified 20 instances of acidosis reported as diabetic ketoacidosis, ketoacidosis or ketosis in patients taking Invokana or another SGLT2 inhibitor between March 2013 and June 6, 2014, and according to the FDA, “All patients required emergency room visits or hospitalization to treat the ketoacidosis.”

In another drug safety communication issued in December 2015, the FDA added new warnings to the labels of SGLT2 inhibitors like Invokana regarding the risks of diabetic ketoacidosis and serious urinary tract infections, both of which can result in hospitalization. The FDA also identified 73 cases of ketoacidosis in patients with Type 1 or Type 2 diabetes treated with SGLT2 inhibitors between March 2013 and May 2015, and warned that “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.”

Contact a Diabetic Ketoacidosis Lawyer Today

The medical complications associated with diabetic ketoacidosis are serious and may even be life-threatening, and individuals who develop DKA side effects while taking a medication like Invokana may be entitled to compensation for their losses. If you believe you have been adversely affected by diabetic ketoacidosis side effects of Invokana or another diabetes medication, don’t hesitate to seek legal help from a qualified product liability lawyer. You may qualify for reimbursement for damages like past and future medical expenses and pain and suffering, which you can pursue by filing an Invokana lawsuit against the drug manufacturing company.

Symptoms of Kidney Failure

Invokana Symptoms, Kidney Failure, News

Kidney failure is a medical condition that occurs when the kidneys are no longer able to filter waste products from the blood and balance fluids in the body, and research has shown that patients taking certain pharmaceutical drugs, namely sodium-glucose cotransporter-2 (SGLT2) inhibitors like Invokana, may face an increased risk of kidney failure side effects. Invokana and other drugs belonging to the SGLT2 inhibitor class of drugs are commonly prescribed to help control blood glucose levels in adults with Type 2 diabetes, but the medications have been linked to an increased risk of kidney failure and other side effects in recent years. If you have been diagnosed with kidney failure, and you believe Invokana or another diabetes drug to be the cause, consult an experienced product liability lawyer today for legal help.

Symptoms of Kidney Failure // Invokana Lawsuit Help Center

Kidney Failure Warning Signs

The kidneys are responsible not only for removing wastes from the body and balancing fluids, they also help regulate blood pressure and are involved in the production of red blood cells. When the kidneys are no longer able to function properly, the following symptoms may occur:

  • Shortness of breath
  • Weakness
  • Confusion
  • Lethargy
  • Abnormal heart rhythms
  • Decreased urine output
  • Fluid retention
  • Drowsiness
  • Nausea
  • Seizures or coma
  • Sudden death

Possible Causes of Kidney Failure

There are two types of kidney failure: acute renal failure and chronic kidney disease. Acute renal failure, which develops rapidly over the course of a few hours or a few days, occurs when the kidneys are suddenly unable to filter waste products from the blood, causing dangerous levels of wastes to accumulate in the body and knocking the body’s chemical makeup out of balance. On the other hand, chronic kidney disease is characterized by a long-standing disease of the kidneys that eventually leads to renal failure over the course of several months or years.
There are a number of possible causes of kidney failure, one being the use of certain prescription medications, namely SGLT2 inhibitor diabetes drugs like Invokana. In a drug safety communication issued by the FDA in December 2015, the agency identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections with the use of SGLT2 inhibitor medications between March 2013 and October 2014. According to the FDA, “All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

Kidney Failure Treatment and Complications

Treatment for kidney failure typically requires a hospital stay, and identifying the underlying factors contributing to the condition is the first step in returning kidney function to normal. Some common kidney failure treatments include the following:

  • ntravenous fluids or diuretics to balance fluids in the blood
  • Dialysis to remove toxins from the blood
  • Medications to control potassium
  • Medications to restore blood calcium levels

In some cases of kidney failure, the damage to the kidneys may be irreversible, and if the kidneys fail completely, the only available treatment options may be dialysis or a kidney transplant. Without prompt treatment, kidney failure may result in serious complications, like chest pain, muscle weakness, a buildup of fluid in the lungs, permanent kidney damage or death.

An Experienced Kidney Failure Attorney Can Help

Whatever the cause of your kidney failure, it is imperative that you seek immediate medical attention to reduce the risk of long-term complications or death, and to identify the underlying cause of the medical condition. If you believe your kidney failure was caused by the use of an SGLT2 inhibitor diabetes drug like Invokana, contact a reputable product liability lawyer as soon as possible to explore your possible compensation options. Patie
nts who have been harmed by alleged side effects of pharmaceutical drugs may be entitled to financial compensation for their injuries, medical bills, emotional trauma and other damages, and with an experienced Invokana attorney on your side, you can ensure that your legal rights are protected and seek fair and timely reimbursement for your losses.

Side Effects of Type 2 Diabetes Drugs May Outweigh Benefits

Diabetic Ketoacidosis, Kidney Failure, News, Urinary Tract Infection

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

Diabetic Ketoacidosis, Heart Attack, Kidney Failure, News, Stroke, Urinary Tract Infection

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

Diabetic Ketoacidosis, News, Urinary Tract Infection

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.

Diabetes Drug Invokana Linked to Kidney Failure

Kidney Failure, News

Possible Invokana Side Effects

Invokana (canagliflozin) is a prescription drug designed to control blood sugar levels in adults with Type 2 diabetes, which it does by inhibiting a protein called sodium-glucose cotransporter-2 (SGLT2), thereby preventing the kidneys from reabsorbing glucose and causing them to excrete more glucose in the urine. However, there have been dozens of reports of potentially life-threatening complications occurring in patients taking Invokana and similar SGLT2 inhibitors, and researchers have advised healthcare professionals to exercise caution when prescribing the diabetes medication, due to the risk that Invokana may increase a patient’s chances of suffering diabetic ketoacidosis or kidney failure complications.

Risk of Kidney Failure from Invokana

Because Invokana is designed to act on the kidneys to lower glucose levels, the medication poses serious risks for patients who have pre-existing kidney problems. Even diabetes itself can cause damage to the kidneys over time, and patients with late-stage diabetes who take a drug like Invokana may significantly increase their chances of suffering kidney failure. In its QuarterWatch report released in May 2015, the Institute for Safe Medication Practices (ISMP) indicated that Invokana was named in more than 457 adverse event reports submitted during the first year the drug was on the market, including 54 reports of kidney damage or kidney failure. This report came on the heels of a drug safety communication from the FDA warning about the alleged risk of diabetic ketoacidosis side effects from Invokana.

FDA Revises Invokana Warning Label

In another FDA safety announcement issued in December 2015, the FDA added new warnings to the labels of SGLT2 inhibitors like Invokana, indicating that the diabetes drugs may increase the risk of complications like ketoacidosis and serious urinary tract infections, both of which can result in hospitalization. According to the December 2015 safety announcement, the FDA had 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 to 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.”

An Experienced Invokana Lawyer Can Help

In light of these serious risks, the FDA is requiring the makers of Invokana and other SGLT2 inhibitors to conduct post-marketing research to identify reports of spontaneous diabetic ketoacidosis and other side effects in patients treated with the diabetes drugs. If you took an SGLT2 inhibitor like Invokana, and you have since been diagnosed with diabetic ketoacidosis, kidney failure or another serious medical condition, an experienced Invokana attorney can help. With a qualified lawyer on your side who has experience handling Invokana injury claims, you can ensure that your legal rights are protected, and seek fair and timely reimbursement for your injuries, past and future medical costs, and pain and suffering.