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Farxiga

The Farxiga injury attorneys at the Drug Law Center are now accepting defective diabetes drug cases where patients have suffered serious harm or died from a wrongful death.

Introduction

Farxiga RecallFarxiga (dapagliflozin) is a Bristol-Myers Squibb Type II diabetes treatment medication that is manufactured in partnership with AstraZeneca. Doctors prescribe the medication to individuals with type II diabetes as an effective way to manage blood sugar levels. The drug makers say the potential benefits of using the drug to treat type II diabetes when exercising and making healthier diet choices can lower A1C and reduced systolic blood pressure. Though Farxiga is not a weight loss medication, patients taking the drug have lost weight and reduced their systolic blood pressure. However, the medication has been linked to the potential risk of developing kidney failure and DKA (diabetic ketoacidosis) a life-threatening condition involving elevated levels of acid in the bloodstream.

The History of Farxiga

Farxiga is a relatively new medication that was approved by the U.S. Food and Drug Administration (FDA) in January 2014. The medicine is taken orally once every day and has proven to be effective when used as an adjunct to exercise and diet. For patients suffering from Type II diabetes, the medicine improves glycemic control. Farxiga and its generic form dapagliflozin are gliflozin class medications.

In 2011, the company attempted to get approval from the FDA. However, the endocrine logic and metabolic drug advisory committee turned down the approval claiming the panel needed more data. By 2012, the European medicines agency gave a positive opinion on the medication. Two years later, the FDA approved the medication in its regular and extended release form (October 2014). Recently in February 2017, the Food and Drug Administration approved Qtern, a once-daily medication that combines dapagliflozin with saxagliptin.

How Farxiga Works

The Type II diabetes treatment medication assists the kidneys and flushing away sugars through new urination that have accumulated in the body. Clinical trial results involving type II diabetic adults revealed that the medicine removed 70 grams of sugar on average per day through urination after the medication had been taken for three months. Farxiga is an STLT2 (sodium glucose co-transporter 2) class of type II diabetes drug that is known to block some reabsorption of sugar in the kidneys.

Who Should Avoid Taking Farxiga

No one under 18 years of age should take Farxiga without medical advice. Patients with known allergic reactions to Farxiga and dapagliflozin or any of its ingredients should avoid taking the drug. Additionally, those on dialysis or suffering severe kidney problems should not take Farxiga. Doctors will often perform a blood test to check how well the patient’s kidneys are functioning before prescribing Farxiga or during treatment.

While there is no conclusive evidence that pregnant women should or should not take Farxiga because it might cause harm to an unborn baby, there are other appropriate alternative therapies that should be considered, especially when the childbearing woman is in her second and third trimester. Nursing mothers should either discontinue nursing or discontinue taking Farxiga.

Avoid taking the medication if you suffer from diabetic ketoacidosis or severe kidney disease. The medicine may not be safe to take if you suffer from:

  • Liver disease
  • Kidney disease
  • Bladder cancer
  • Low blood pressure
  • Congenital heart failure
  • High cholesterol level
  • When on a low salt diet
  • When taking oral diabetes medications or insulin
  • Are currently taking blood pressure medicine

The medication is known to cause dizziness when getting up too fast from a lying down or sitting up position. The pharmaceutical manufacturer suggests getting up slowly to prevent falls.

Farxiga and Ketoacidosis

Studies of indicated there is a direct link between taking Farxiga and developing ketoacidosis, which is a life-threatening condition that occurs when acid levels in the bloodstream become excessively high. Diabetic patients are especially at risk when there are insufficient levels of insulin to produce a source of energy delivered to the bloodstream. At that point, the body begins burning toxic fatty acids (ketones) that build up in the body. Key tones are known to produce serious side effects. Common symptoms include unusual fatigue, confusion, vomiting, nausea and difficulty in breathing.

While ketoacidosis is commonly associated with type II diabetes, they can also occur in individuals suffering from1 diabetes or other conditions. Some of the complications associated with ketoacidosis include coma, loss of consciousness, low blood pressure-associated bowel tissue damage, heart attack, swelling in the brain (cerebral edema), and death.

Farxiga and Diabetic Ketoacidosis

Researchers found a correlation between taking the diabetic treatment medication Farxiga and the development of diabetic ketoacidosis. This condition occurs when the body is not producing enough insulin, which can be a common occurrence in diabetic patients. In response, the body burns fat cells to generate fuel. It does this by releasing acid waste ketones that build up in blood and urine. The condition can also produce life-threatening reactions and consequences.

Individuals suffering from ketoacidosis should seek immediate medical attention for treatment if they have difficulty in breathing, vomiting, nausea, confusion, abdominal pain, sleepiness, or unusual fatigue.

Farxiga Off Label Use

Advocacy groups are demanding that the Food and Drug Administration against AstraZeneca and threaten civil fines if they continue to market unapproved “off-label” uses of Farxiga, including taking the medication to lose weight. To date, the pharmaceutical giant has never evaluated Farxiga to be effective or safe for treating weight loss. Advocates claim that the drug company inflates the perceived benefits of taking the medication and marketers of the medication dangerously skew the benefits over risks doctors make when prescribing and patients make when determining if they should use the drug for “off-label” purposes including weight loss.

Farxiga Side Effects

Farxiga in its generic form dapagliflozin display frequent side effects and adverse reactions. The most common side effects involve urinary tract infection, genital candidiasis, bacterial vaginosis, vulvovaginal candidiasis, cystitis, prostatitis, pyelonephritis, bacterial infection, urethritis, vulvovaginitis, and vulvitis.

The safety and efficacy of using Farxiga or dapagliflozin in children have yet to be performed, so no determination on its use in young patients have yet to be established. In addition, no appropriate every search has been conducted to demonstrate it geriatric problems could limit the efficiency and safety of dapagliflozin taken by elders. Typically, older adults are more likely to suffer unwanted side effects including low blood pressure and kidney problems that might require a cautious approach.

Allergic reactions to Farxiga can occur in patients taking the drug. Reactions can involve hives, swelling of the tongue, throat, lips or face, or have difficulty in breathing. Other known Farxiga side effects include:

  • A lightheaded sensation of fainting
  • Detectable blood in the urine
  • Unusual frequent urination
  • Difficult or painful urinating
  • Bright red urine
  • Kidney stones
  • Kidney cancer
  • Bone fractures
  • Testicular cancer
  • Fungal infections
  • Anxiety, confusion, and nightmares
  • Increased thirst or hunger
  • Seizures, dizziness, fast heartbeat, headaches
  • Pale, cool skin
  • Blurry vision
  • Difficulty in having a bowel movement
  • Slurred speech
  • Unexpected weight gain
  • Depression
  • Symptoms of dehydration including feeling hot, very thirsty, heavy sweating, dry or hot skin, or the inability to urinate
  • Symptoms of ketoacidosis including stomach pain, vomiting, nausea, unusual drowsiness, confusion, or difficulty in breathing
  • Genital (vagina or penis) infections indicators including redness, rash, itching, burning, discharge, odor, or pain
  • Tightness in the chest
  • Swollen eyes or eyelids
  • Dry mouth
  • Wrinkled skin
  • Kidney problems that include shortness of breath, feeling tired, ankles or feet swelling, or little to no urination
  • bladder infections indicators including back her pelvis pain, cloudy urine, and a burning or painful sensation when urinating

While the side effect list is long, there are certainly other effects and adverse reactions that do occur.

Farxiga Interactions

The doctor should have a comprehensive list of all medications the patient is taking before prescribing Farxiga. Common drug interactions that could affect the efficiency and safety of Farxiga include:

  • Taking water (diuretic) pills
  • Taking blood pressure or heart medication
  • Taking NSAID (nonsteroidal anti-inflammatory drugs) that could include naproxen (Aleve), ibuprofen (Motrin, Advil), meloxicam, indomethacin, celecoxib, or others.
  • Excessive consumption of alcohol that might cause a significant change in blood sugar levels
  • Some herbal products, vitamins, over-the-counter drugs, and prescription medications may interact with the active ingredients in dapagliflozin (Farxiga). Some beta blocker drugs including glaucoma eyedrops, propranolol, and metoprolol could prevent racing pounding heartbeats that are typically associated with hypoglycemia when the levels of blood sugar fall too low.

Farxiga Lawsuits

To date, the FDA has yet to recall Farxiga in the United States or worldwide. However, many victims who have suffered serious injuries have filed claims and lawsuits seeking financial compensation from the drug maker to recover their damages including ongoing medical expenses, lost wages, the inability to earn a living in the future, pain, suffering, and emotional distress.

  • Farxiga Black Box Warnings Strengthened in Response to FDA Demands

March 2017 – The Food and Drug Administration announced the agency was strengthening black box warnings on Farxiga and Xigduo XR (an extended release diabetic medication formulated with metformin and dapagliflozin) because of certain safety issues with the medications. Previously, the FDA at investigated the correlation between taking the medication and the display of certain side effects including ketosis, ketoacidosis, and diabetic ketoacidosis (DKA).

  • Multiple Farxiga Lawsuit Plaintiff Seeking Centralization to Promote Judicial Efficiency

April 2017 – In February of this year, eighteen plaintiffs filing Xigduo XR and Farxiga lawsuits requested the federal judge centralize their cases in the hope of promoting judicial efficiency. These plaintiffs claimed that they suffered kidney damage, diabetic ketoacidosis, and other kidney-associated injuries after taking the type II diabetes treatment medication.

Hiring a Farxiga Lawyer

The Farxiga injury attorneys at the Drug Law Center are standing by to provide legal assistance if you have been injured or lost a loved one who used the diabetic medication. Our law firm has access to vast resources and comprehensive understanding of personal injury tort law. We understand that our clients have not only been injured but suffered financial devastation by incurring ongoing medical bills, lost income, lost the inability to earn income in the future, and became disabled. We seek to find the highest level of compensation by negotiating settlements out-of-court or winning the case to trial on behalf of our clients.

We urge to contact our diabetes medication injury law firm today to schedule a comprehensive case consultation at no charge to you or your family. We are currently accepting all Farxiga lawsuits and compensation claims through contingency fee arrangements. This means we will postpone the payment of our legal services and only charge you if we successfully resolve your case. Our “No Fee / No Pay” guarantee assures that you will never pay out-of-pocket for our legal representation. Contact us immediately if you or someone you know was diagnosed with injuries caused by side effects after taking Farxiga.

Sources:
https://www.farxiga.com/
https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm506554.htm
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf

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