FDA Strengthens Kidney Warnings on Invokana Labeling

FDA Strengthens Kidney Warnings on Invokana Labeling

Posted By Golomb & Honik, P.C. || 9-Aug-2016

A Drug Safety Communication warning was issued by the FDA on June 14, 2016 regarding Invokana (canagliflozin), a Type 2 diabetes drug manufactured by Johnson & Johnson. Invokana works to lower levels of blood sugar by boosting the amount of sugar that is removed through the urine. Another similar SGLT-2 drug, Farxiga (dapagliflozin), was also targeted by the FDA, which asked the manufacturer to provide stronger warnings regarding the risks of acute kidney injury.

Serious Kidney Failure and Injury Linked to SGLT-2 Drugs

According to FDA records, within an 18-month period, the SGLT-2 class of prescription drugs was linked to at least 101 verifiable instances of serious kidney failure and injury. Seventy-three of these injuries were related to the use of Invokana and 28 to Farxiga. Some of the patients associated with these cases of kidney damage required hospitalization and/or kidney dialysis, four patients died while hospitalized, and 22 required admission to intensive care. The FDA found that in at least 50 percent of the patients who suffered serious levels of injury to their kidneys, those injuries happened within the first thirty days of taking Invokana. Among some patients, the acute kidney injuries resolved when Invokana was discontinued, however the FDA warns that kidney injuries are not always reversible.

Latest Kidney Warning Comes on the Heels of Invokana Amputation Warnings

This latest requirement for stronger warning labels comes on the heels of an FDA warning issued in May of this year stating that those taking Invokana could potentially face an increased incidence of foot and leg amputations. The announcement regarding amputations resulted from a clinical trial in progress, which issued interim safety results. The study, known as the Canagliflozin Cardiovascular Assessment study, or CANVAS, had the following results: over a period of a single year, seven out of 1,000 subjects taking 100 mg of Invokana had an elevated risk of amputation as compared to three out of 1,000 patients who received a placebo drug. The warnings regarding Invokana could have an adverse effect on the $1.3 billion Johnson & Johnson made from the sales of the drug in 2015.

Factors Which May Predispose Patients to Acute Kidney Injury

The FDA warned that healthcare professionals should consider the factors which could potentially predispose a patient to acute kidney injury prior to prescribing Invokana. These factors include:

  • Congestive heart failure;
  • Chronic kidney insufficiency;
  • Patient’s use of other medications such as NSAIDS, angiotensin receptor blockers, angiotensin-converting enzymes and diuretics, and
  • Decreased blood volume.

The agency noted that any patient starting Invokana (canagliflozin) or Farxiga (dapagliflozin) should be monitored for any changes in kidney function. Should such a change be noted, the drug should be discontinued and any impairments treated.

Canadian Patient Claims Invokana Harm

In an interview given to the Canadian Broadcasting Corporation in the fall of 2015, a Scarsborough, Ontario woman, claimed she had been taking Invokana for only a short time when she found she had sustained damage to her kidneys and renal system. She is currently pursuing a class-action lawsuit in Canada against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals. The plaintiff seeks both punitive and compensatory damages due to her belief that the potential risks associated with Invokana were significantly understated.

Invokana Lawsuits in the United States

In the United States, there are more than 150 Invokana lawsuits pending in Missouri and Illinois, as well as cases in Philadelphia and New Jersey. One New Jersey woman suffered diabetic ketoacidosis and severe kidney damage after taking Invokana for only a month. The woman asserts that she would not have taken Invokana had she been aware of the risks associated with the drug, and claims in her lawsuit that J & J and Janssen Pharmaceuticals negligently marketed and sold Invokana.

If you have suffered kidney damage or injury (or diabetic ketoacidosis or amputation), it could be very beneficial to contact an experienced Invokana attorney who can assess your situation and determine the best course of action for your individual circumstances.

Contact Us to Request a Case Evaluation

If you or a family member has been diagnosed with kidney damage or injury after taking the drug Invokana, contact our firm today. One of our experienced Philadelphia product liability attorneys will evaluate your case and help you determine if you are entitled to compensation.

To learn more about your legal options or to schedule a free consultation, call Golomb & Honik, P.C. today at (215) 278-4449. We represent clients in Pennsylvania and throughout the United States.

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