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HARMED BY DANGEROUS DIABETES MEDICATION INVOKANA?

Invokana (canagliflozin) is a pharmaceutical drug prescribed to treat type 2 diabetes. Manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson, Invokana falls within the SGLT2 inhibitor class of diabetes drugs. These types of diabetes medications, with a healthy diet and exercise regimen, can improve glycemic control. Invokana can be used as a singular treatment or in combination with other diabetes medications. The drug was the first SGLT2 inhibitor approved by the FDA and was introduced to the market in 2013.

SGLT2 inhibitors work by blocking the reabsorption of glucose in the kidney, increase glucose excretion, and lower blood glucose levels.

Unfortunately, Invokana is a dangerous drug with many serious and potentially life-altering or fatal side effects.

Severe side effects associated with Invokana include:

  • Dehydration
  • Yeast infection
  • Hypotension
  • Ketoacidosis
  • Kidney injury and renal impairment
  • Hyperkalemia
  • Serious urinary tract infections
  • Bone fractures
  • Increased risk of leg and foot amputation

BLACK BOX WARNING: INCREASED RISK OF LOWER EXTREMITY AMPUTATIONS

UPDATE: On May 16, 2017, the FDA confirmed the increased risk of leg and foot amputations with canagliflozin, based on data from the CANVAS and CANVAS-R clinical trials. With the confirmation, the FDA is requiring new warnings, including a black box warning, to be added on all drugs containing canagliflozin, including Invokana. Results from the clinical studies showed that leg and foot amputations occurred nearly twice as often in patients taking Invokana than patients receiving a placebo treatment.

Amputations of the toe and middle of the foot were the most common, according to the results of the clinical trials. Some amputations involved the leg, both below and above the knee, and others included both limbs. According to researchers, rates of amputation were as high as 7 in 1,000 for Invokana patients.

In 2016, the FDA sent out a safety announcement to the public regarding the result of an ongoing clinical trial. The safety results from the trial indicate an increase in leg and foot amputations in patients being taking canagliflozin (Invokana and Invokamet) for treatment of diabetes. According to the FDA, the data comes from the Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial. The amputations have occurred about twice as often in patients being treated with canagliflozin than those taking a placebo.

A second study (CANVAS-R) evaluating the risks of canagliflozin has not shown the same increased risk of amputations. However, the patients in the CANVAS-R clinical trial have on average been followed for nine months compared to 4.5 years for those in the CANVAS study. The FDA is continuing to evaluate the issue and will provide updated information when available.

INVOKANA CAUSES INCREASED RISK OF DEVELOPING KETOACIDOSIS

Ketoacidosis, or diabetic ketoacidosis (DKA), occurs when your body produces high levels of blood acids (ketones). Ketoacidosis can develop if your body isn’t producing enough insulin, which helps glucose enter cells. When the body instead breaks down fat as fuel, ketones build up in the bloodstream. Symptoms of ketoacidosis include

  • Frequent urination
  • Abdominal pain
  • Shortness of breath
  • Confusion
  • Weakness or fatigue
  • Excessive thirst

Hyperglycemia (high blood sugar level) and high ketone levels in urine are also potential signs of ketoacidosis. If left untreated, ketoacidosis can lead to hypoglycemia, hypokalemia, swelling of the brain, loss of consciousness, and death. Ketoacidosis can also be spurred by urinary tract infections, which can also be caused by Invokana.

INVOKANA INCREASES RISK OF URINARY TRACT INFECTIONS

Urinary tract infections that require hospitalization have occurred in people taking Invokana. Months after issuing the warning regarding the increased risk of ketoacidosis in Invokana patients, the FDA revised the warning with an alert on urinary tract infections.

Signs and symptoms of a urinary tract infection include:

  • Burning sensation when urinating
  • Need to urinate often or right away
  • Lower stomach or pelvis pain
  • Fever
  • Blood in urine

People taking Invokana are advised to contact their healthcare provider immediately if any of these symptoms are experienced. As mentioned before, urinary tract infections are severe, may require hospitalization, and could lead to ketoacidosis — a fatal condition.

FDA STRENGTHENS ACUTE KIDNEY INJURY WARNING FOR DIABETES MEDICATIONS

In 2016, the FDA strengthened the existing warnings regarding the increased risk of acute kidney injury in several diabetes medications, including Invokana, Invokamet, Farxiga, and Xigduo DR. Acute kidney injury is a serious condition in which the kidneys suddenly stop working. When the kidneys shut down, dangerous waste builds up inside your blood. This condition can cause complications in other organs, including the brain, heart, and lungs.

Signs of acute kidney injury include:

  • Swelling in legs, ankles, around the eyes
  • Fatigue
  • Shortness of breath
  • Nausea
  • Chest pain or pressure
  • Seizures
  • Confusion
  • Too little urine leaving the body
  • Coma

If left untreated or undiagnosed, acute kidney injury could lead to more serious kidney diseases or kidney failure.

BONE FRACTURES ASSOCIATED WITH INVOKANA

Fractures are more likely to occur in patients taking Invokana than those taking a placebo. The U.S. Food and Drug Administration (FDA) warns that fractures can occur as early as three months after starting Invokana treatment.

In 2015, the FDA strengthened the warning required on the labels of Invokana regarding the increased risk of bone fractures. In addition to increasing the risk of broken bones, Invokana has been linked to a greater loss of bone density in elderly patients at the hip and lower spine compared to a placebo.

CONTACT AN EXPERIENCED DANGEROUS DIABETES MEDICATION ATTORNEY

Invokana has been hailed as a wonder drug for diabetes treatment. Unfortunately, some people are left in worse shape than before once they take Invokana. If you or a loved one have been the victim of an injury or illness caused by Invokana, contact Thomas J. Henry. Our experienced pharmaceutical litigation lawyers are available 24/7, nights and weekend. We can provide you with a free case review to see if you are entitled to compensation for your injuries.

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