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Invokana

The Invokana injury case attorneys at the Drug Law Center represent clients who have suffered injury or died prematurely after taking the Type II diabetes treatment medication.

Introduction

Invokana Drug RecallInvokana (canagliflozin) is a prescription oral diabetes drug that has been proven to be effective at controlling blood sugar levels. The active ingredient canagliflozin is effective because it helps the kidneys remove glucose from the bloodstream, especially when used together with exercise in a nutritional diet. The medication has not been approved for treatment of Type I diabetes. If patients can control their blood sugar levels, they can prevent numerous serious life-threatening consequences including nerve damage, blindness, kidney issues, sexual dysfunction, and loss of limbs. In addition, proper control of the diabetic condition can also reduce the potential risks of experiencing a stroke or heart attack. Even though the medication has been approved by the Food and Drug Administration (FDA), there have been significant side effects and several warnings concerning taking the diabetic treatment medication.

The History of Invokana

In 2012, Mitsubishi Tanabe Pharma first developed Invokana under its generic name canagliflozin that was later made and marketed by a Johnson & Johnson subsidiary Janssen Pharmaceuticals. The following March (2013), the FDA approved the first SGLT2 inhibitor medication Invokana as an effective treatment for Type II diabetes. The next year (2013) the Food and Drug Administration orders the drug maker to conduct post-marketing clinical trials. By the end of the year, Janssen Pharmaceuticals began marketing Invokana for weight loss even without FDA approval.

In May 2015, a warning was issued by the Food and Drug Administration indicating there are ketoacidosis complications in patients who take Invokana. By September, a request is made by the FDA for Janssen Pharmaceuticals to update the warning labels on Invokana to include fractures. The first Invokana lawsuit was filed in Canada, followed by filed suits in the United States. Four months after the label change request from the FDA, Janssen Pharmaceuticals adds warnings of the potential risk of developing ketoacidosis and UTI (urinary tract infection).

In January 2014, a published report reveals that there are over 5400 adverse events linked to taking Invokana. Five months later in May, the Food and Drug Administration revealed the increased potential of foot and leg amputations by patients taking the diabetic medication. In June 2016, the FDA strengthens warnings indicating kidney problems are occurring in patients taking Invokana. Since the product was first brought the medical marketplace, many patients prescribed Invokana have suffered serious side effects severe enough to necessitate hospitalization or visits to the emergency room to treat their developing ketoacidosis.

Invokana Side Effects

The Invokana warning labels clearly state many of the known side effects reported by doctors and patients who have been prescribed the medication. Commonly known side effects include:

  • Dehydration caused by the loss of salt water in the body
  • Ketoacidosis
  • Excessive thirst
  • Weakness and fatigue
  • Nausea
  • Constipation
  • Penis-related yeast infections
  • Vaginally yeast infections
  • Kidney issues
  • Bone fractures
  • Hypoglycemia (low blood sugar levels)
  • Hyperkalemia (elevated levels of potassium in the bloodstream)
  • Elevated cholesterol levels
  • Frequent urination in larger amounts
  • Frequent urination at night
  • Severe cases of UTI (urinary tract infection – urosepsis)
  • Skin reaction hypersensitivity including skin swelling, hives, itching, rash, and redness.

Less common side effects include:

  • Anxiety
  • Irregular or fast heartbeat
  • Dry mouth
  • Shakiness
  • Swelling of the lips, eyelids, face, feet, legs, hands, throat, tongue, or sex organs
  • Nightmares
  • Headaches
  • Confusion
  • Cold sweats
  • Dizziness
  • Blurry vision
  • Seizures
  • Increased skin sensitivity to sunlight
  • Severe sunburn
  • Skin discoloration

Invokana Contraindications

Like all prescription and over-the-counter medications, Invokana has contraindications, where patients taking other medications, experiencing serious side effects, or suffering certain medical conditions should avoid taking the diabetic treatment medication. The most common contraindications of using Invokana include:

Individuals with a history of hypersensitivity reaction to taking Invokana including angioedema (recurrence subcutaneous edema) and anaphylaxis should avoid taking Invokana. In addition, individuals suffering severe renal impairment, end-stage renal disease (SRT) or those currently on dialysis treatments should not take the diabetic treatment drug.

Previously Known Cardiovascular Side Effects

Before the Food and Drug Administration (FDA) approved Invokana for consumer use, there was ongoing debates and investigations conducted by agency panel members into the drug safety and efficacy concerning cardiovascular health. One clinical study revealed numerous CV (cardiovascular) events occurring in a group of patients taking Invokana. This was compared to others taking just the placebo. The panel concluded that there were unresolved questions about the relatively limited amount of available data over the elevated incident rates of participants having strokes and other events.

Additionally, the watchdog group Public Citizen gave testimony in front of Congress in 2013 arguing the potential developing risks in taking Invokana, and other diabetic medications, significantly outweigh the potential benefit the patient would receive from taking the medication. It was the recommendation of Dr. Sidney Wolfe to not approve the medication. Since then, numerous safety groups like ISMP (Institute for Safe Medication Practices) said that Invokana (canagliflozin) did not produce enough sufficient testing results in clinical trials and did not agree with the FDA drug approval.

More lawsuits were filed in 2015 once the Food and Drug Administration issued a warning that Invokana and other SGLT2 inhibitors could cost ketoacidosis, a serious life-threatening condition where high levels of blood assets (ketones) developed in the body and cause extreme acidity in the blood. At that time, the FDA was reviewing dozens of reports noting adverse events happening to patients currently taking the medication who required hospitalization.

Invokana is not the only medication that cost ketoacidosis. Ketoacidosis can be caused by taking Farxiga, Invokamet, Jardiance, Glyambi, Xigduo and all their generic versions.

Lawsuits Filed against Janssen Pharmaceuticals on the Rise

Many plaintiffs filing Invokana lawsuits are stating that the drug maker failed to warn them, other consumers, doctors and the medical community of the increased potential risk of developing kidney failure, ketoacidosis and heart attacks (myocardial infarction). Successful attorneys resolving Invokana losses have argued that their clients would have made other choices and not taking the medication and they understood the serious side effects.

In addition, those needing to take some type of diabetic medication could have had the opportunity to monitor their health on a frequent basis to look for any potential indicators of elevated ketone levels, renal impairment, or heart issues. These cases are built on Janssen Pharmaceuticals’ choice to place profits ahead of consumer safety.

Many attorneys are filing claims on behalf of their clients building a case on the consideration that there is a correlation between taking Invokana and cardiovascular complications and kidney failure. Many of these cases are settled out of court. However, there will be many more filed against Janssen Pharmaceuticals and their parent company Johnson & Johnson in the years ahead.

Invokana Lawsuits

  • Family Member Files Invokana Urosepsis Wrongful Death Lawsuit

April 2017 – Johnson & Johnson, its subsidiaries Janssen pharmaceuticals, and Mitsubishi Tanabe Pharma Corporation are facing in Invokana urosepsis lawsuit filed by a woman who alleges that the wrongful death of her mother was caused by the diabetic medication. The plaintiff is filing the case on behalf of her mother who died after enduring pain and suffering, loss of enjoyment, emotional distress, and economic loss before her wrongful death that occurred in March 2015 from urosepsis (severe urinary tract infection).

The lawsuit documents reveal the plaintiff’s mother developed a severe case of urosepsis after years of taking the diabetic medication. Her condition led to septic shock that ended with fatal congestive heart failure when she suffered myocardial infarction just before she died.

  • Alabama Couple Files a Invokana Ketoacidosis Lawsuit against Janssen

November 2016 – Janssen Pharmaceuticals, and its parent company Johnson & Johnson are facing another Invokana lawsuit, this time from an Alabama, the wife developed life-threatening diabetic ketoacidosis after taking the drug. The plaintiffs claim that the drug maker was aware, or should have been aware, of the potentially serious side effects associated with using the medication.

Lawyers working on behalf of the plaintiffs state that Janssen continued to manufacture and market the medication as though it was both effective and safe while actively misleading consumers, doctors and the medical community through their concealment of information known about Invokana risks.

The lawsuit is based on the drug maker’s defective design, other negligence, their breach of implied and express warranties, a failure to warn consumers, concealment of information, fraudulent misrepresentation, and a loss of consortium between the plaintiffs.

  • Two Women File Invokana Defect Lawsuit against Janssen Pharmaceuticals

February 2017 – Pharmaceutical giant Johnson & Johnson and their subsidiary Janssen Pharmaceuticals are facing another Invokana defect lawsuit, this time filed by two women who were injured after taking diabetic medication. Lawsuit documents reveal that in 2013, one plaintiff began taking Invokana to treat her diabetes. The other plaintiff began taking the medication in January 2015.

Both women believed that the claims made by Janssen pharmaceuticals led to believe that the product was both effective and safe. One plaintiff developed numerous serious health issues caused by an Invokana defect when she developed diabetic ketoacidosis, Stage III kidney failure, and stroke, that led to her hospitalization.

The other plaintiff suffered a variety of major complications caused by Invokana defects including a life-threatening case of diabetic ketoacidosis. Have they been made aware of the serious side effects associated with taking Invokana, including kidney problems, and diabetic ketoacidosis, they would have made better-informed decisions and likely not taking the medication at all. Lawyers working on their behalf have filed the case building a lawsuit by numerous counts including negligence, failing to warn, strict product liability, and negligent misrepresentation.

Our Product Liability Law Firm Is Now Accepting Invokana Losses

If you to the diabetic medication and suffered serious injuries or your loved one died prematurely from a wrongful death, you are likely entitled to file a Invokana lawsuit to seek compensation. Your attorney can work on your behalf by building your Invokana case to ensure you receive recovery of your ongoing medical bills, lost wages, the inability to earn a living in the future, suffering, pain, mental anguish, and funeral expenses when a fatal injury occurs.

To be eligible for financial compensation you must have been prescribed and took Invokana, canagliflozin, or any other SDLG2 inhibitor medication. In addition, after taking the medication, you must have suffered kidney issues, ketoacidosis, or another form of unforeseen harm. Surviving family members of a loved one lost to an Invokana injury can also file on behalf of the decedent in a wrongful death claim.

Contact us today to begin the process of resolving your Invokana lawsuit. We offer a free, no-obligation case evaluation to discuss the merits and evidence in your case. We are currently postponing payment of our legal services until after we successfully resolve your claim for compensation or trial lawsuit. Our “No Win / No Payment” guarantee means that if we are unable to obtain financial recovery on your behalf, you owe us nothing.

Sources:
https://www.ismp.org/QuarterWatch/pdfs/2014Q2.pdf
http://www.ismp.org/QuarterWatch/
http://www.mayoclinic.org/drugs-supplements/canagliflozin-oral-route/description/drg-20060957
https://www.fda.gov/Drugs/DrugSafety/ucm446845.htm