Colorado Dangerous Drugs & Medical Devices

Invokamet® / Invokana® Diabetes Medication – Denver Dangerous Drug Attorneys

Type 2 Diabetes Medications – Defective Drug Attorney – Burg SimpsonInvokana ® (canagliflozin) is a prescription diabetes medication that is used in combination with diet and exercise to lower blood sugar levels and lower blood glucose levels in adults with type 2 diabetes.

The most serious Invokamet® and Invokana® side effects are kidney damage, ketoacidosis, myocardial infarction, and lower limb amputation::

  • Kidney Failure (also known as renal failure diagnosis) occurs when the kidneys stop functioning correctly and do not properly filter waste products from the blood. Kidney failure is a serious medical condition that requires treatment. These kidney problems can cause fatigue, confusion, weakness, muscle damage, and death.
  • Diabetic Ketoacidosis occurs when the body cannot use glucose for energy and instead breaks down fat and proteins. As a result, dangerous levels of acid, known as ketones, build up in the body causing symptoms such as nausea, vomiting, abdominal pain, and shortness of breath.  This is a serious, life-changing medical condition that requires intensive treatment and can result in organ failure, coma, or even death.
  • Myocardial Infarction (also known as a heart attack) occurs when blood flow is restricted to your heart, depriving it of oxygenated blood, causing heart failure. When the heart has a lack of oxygen supply for too long, the tissues begin to die. A heart attack is a serious medical condition that can cause death and requires immediate medical attention.
  • Lower Limb Amputations, or the surgical removal of a leg (either below or above the knee), foot, or toe(s) from the body.

The claim in the Invokana® cases is that if the manufacturer had warned of the possible risks involved with taking this medicine, patients could have possibly avoided these serious complications. Patients taking Invokana® would have also been warned from the beginning to keep a close eye on potential health issues. Burg Simpson is an award-winning law firm that has your best interests at heart. Contact one of our product liability lawyers today by filling out the Free Case Evaluation form if you have been harmed by this drug.

Additional Information

In clinical trials, patients on Invokana® were more likely to develop diabetic ketoacidosis than patients on other SGLT2 inhibitors. Ketoacidosis normally involves a very high level of sugar in the blood. Many Invokana® users with normal or mildly-elevated blood-sugar have developed ketoacidosis. Because of ketoacidosis’ unusual symptoms, diagnosis can be delayed, resulting in a delay in treatment until it becomes life-threatening.

On May 15, 2015, the FDA issued a Safety Announcement that linked Invokana® and other sodium-glucose cotransporter-2 (SGLT2) inhibitors to ketoacidosis. Additionally, on December 4, 2015, the FDA required Janssen to update Invokana®’s label to include ketoacidosis. The FDA received more than 70 reports of patients who were hospitalized with ketoacidosis between March 2013 and May 2015. It is not known how many cases were not reported to the FDA.

On February 25, 2016, the European Medicines Agency recommended a warning to doctors and patients in order to minimize the risk of diabetic ketoacidosis symptoms in patients taking SGLT2 inhibitors. If you have been affected by the serious effects of Invokana ®, call a Burg Simpson Dangerous Drug Attorney now to discuss the details of your case by filling out the Free Case Evaluation form.

Diabetic ketoacidosis is a medical condition that occurs when toxic wastes known as ketones build up in the bloodstream. The condition usually occurs when the body does not have enough insulin to use glucose (sugar) as a source of energy. Instead of using glucose as an energy source, the body starts burning fat cells, which releases ketones into the bloodstream. High levels of ketones in the body can result in the person going into a diabetic coma (passing out for a long time) or even death.

Symptoms of Diabetic Ketoacidosis can include:

  • Nausea and vomiting
  • Stomach pain
  • Tiredness, fatigue or decreased alertness
  • Deep, rapid breathing
  • Dry skin and mouth
  • Flushed face
  • Frequent urination or thirst that lasts a day or more
  • Fruity-smelling breath
  • Headache
  • Muscle stiffness or aches

Call a Burg Simpson attorney for experienced legal assistance with your case today!

On June 14, 2016, the FDA issued a Drug Safety Communication about the association between Invokana® and acute kidney problems. The Safety Communication reported that “From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to the FDA, so there are likely additional cases about which we are unaware.

In approximately half of the cases, the events of acute kidney failure occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys. The FDA required Janssen to change Invokana®’s label to warn about the risk of acute kidney injury.

Independent medical researchers have also identified Invokana®’s association with kidney problems. According to QuarterWatch, a nonprofit group monitoring serious adverse event reports, Invokana®’s first year of sales was accompanied by numerous “serious injuries involving kidney function.”

In clinical trials, 13 patients on Invokana ® suffered an adverse cardiovascular event such as a heart attack or stroke during the first 30 days of treatment, compared to just one patient on a placebo. Data from the CANVAS trial (Canagliflozin Cardiovascular Assessment Study) linked Invokana ® to a 46% increased risk of cardiovascular events in the first 30 days of use. However, the product information related to Invokana ® does not adequately warn of this increase in risk.

On May 16, 2017, the FDA issued a Safety Announcement advising that data from two recently finished, large-scale clinical trials concluded that the type 2 diabetes medication canagliflozin (Invokana®, Invokamet®, and Invokamet® XR) “causes an increased risk of leg and foot amputations.” Upon learning this information, the FDA required Janssen to update Invokana®’s label to include a black-box warning concerning the almost two-times greater risk of lower limb amputations.  This risk may be even higher for certain individuals.

According to the FDA announcement, the CANVAS trial showed that over the course of one year, the risk of lower limb amputations in patients treated with Invokana® for type 2 diabetes was 5.9 out of every 1000, as compared to 2.8 out of every 1,000 for patients given a placebo (an inactive treatment or medication).

The FDA announcement also reported that the CANVAS-R trial revealed that the risk of lower limb amputation was equivalent to 7.5 out of every 1,000 in patients treated with Invokana®, with the risk only impacting 4.2 out of every 1,000 for patients treated with a placebo.

While amputations of the toe and middle of the foot were the most common among the study subjects, amputations of the leg both below and above the knee were also reported. Moreover, some of the study subjects required multiple lower limb amputations, sometimes involving both the right and left lower limbs.

Previously, on May 18, 2016, the FDA first released a Safety Announcement concerning interim clinical trial results that showed a possible increased risk of leg and foot amputation in patients taking Invokana® for type 2 diabetes.  At the time of the announcement, however, the two clinical trials evaluating the safety of the medication were ongoing. Final data regarding these risks have now been made available upon the conclusion of these trials.

You may be entitled to compensation if you or your loved one used Invokana ® or Invokamet ® as medical treatment for diabetes and developed kidney damage, ketoacidosis, or a myocardial infarction. Call us today to speak with a knowledgeable Burg Simpson Mass Tort Lawyer about the potential for your case.

No. We offer our clients a free, no-obligation case assessment by filling out the Free Case Evaluation form found on this page. We pay for the cost of obtaining your medical records, any expert reviews, and court filing fees. We only receive reimbursement and a fee for our work if the defendant manufacturer pays your claim. If you do not receive a recovery, then you owe Burg Simpson nothing.

Act now and don’t wait! Many have already filed a claim for Invokana ® lawsuits. Indecision could mean losing the opportunity to receive just compensation. The time you have to file a claim depends on a variety of different factors, including the state in which you live. Please call us now to discuss what those factors are.

This latest diabetes treatment was developed by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and approved by the FDA in March 2013. It was the first drug in a new class known as sodium-glucose cotransporter-2 (“SGLT2”) inhibitors.  Invokana® helps to improve glycemic control by causing the kidneys to remove sugar through the urine.  In August 2014, Janssen received FDA approval to begin to market Invokamet® in the United States. Invokamet® a fixed-dose therapy combining Invokana® and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes.

If you or a loved one has suffered the serious illnesses that Invokana® can cause, fill out the Free Case Evaluation form as soon as you can to discuss your case with a Burg Simpson Drug Attorney

Invokana® Case Timeline To Date:

  • March 2013: Invokana® approved by the FDA.
  • August 2014: Invokamet® approved by the FDA.
  • May 15, 2015: FDA issued a safety announcement linking Invokana® to ketoacidosis.
  • December 4, 2015: FDA required Janssen to update Invokana®’s label to warn doctors and patients of the risk of ketoacidosis.
  • February 25, 2016: European Medicines Agency also recommended a warning to doctors and patients in order to minimize the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors.
  • May 18, 2016: FDA issued a safety announcement concerning interim clinical study results showing the possible risk of leg and foot amputation for patients taking Invokana®
  • June 14, 2016: FDA issued a Drug Safety Communication about the association between Invokana ® and acute kidney injury.
  • December 7, 2016: Judicial Panel on Multidistrict Litigation transfers all Invokana® and Invokamet® cases filed in federal courts around the United States to the Honorable Brian R. Martinotti, District Judge for the U.S. District Court of New Jersey.
  • May 16, 2017: FDA issued safety announcement linking Invokana® to an increased risk of the toe, foot, and leg amputations. As a result, the FDA required Janssen to update Invokana®’s label to warn doctors and patients of this increased risk.

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