Invokana

  • Invokana Medical Record Review and Outsourcing Services

Invokana (Canagliflozin) is a drug used for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson in the United States. It belongs to the class sodium-glucose cotransporter 2 (SGLT2) inhibitor. SGLT2 is an enzyme in the kidney tubule that causes glucose to be reabsorbed from urine. By inhibiting the action of SGLT2, Invokana helps the kidneys get rid of glucose from the bloodstream. The U.S. Food & Drug Administration (FDA) approved Invokana on March 29, 2013, for the treatment of type 2 diabetes.

Serious Alleged Injuries may include:

  • Ketoacidosis
  • Kidney Failure
  • Amputation of toe or part of foot

Over a period of time, Invokana has been linked to aggravating certain medical conditions one of them being 'Ketoacidosis', a condition in which the body produces high levels of blood acids known as ketones. If left untreated, this condition can be fatal. Since it's launch in the U.S. markets, several patients have developed ketoacidosis to the point of needing an emergency room visit or hospitalization.

FDA SAFETY WARNINGS:

Since its launch until October 2015, the FDA received several reports of acute kidney injury, some needing hospitalization/dialysis. In June 2016, FDA strengthened the existing warning about the risk of acute kidney injury information about acute kidney injury and added recommendations to minimize this risk. In May 2017, based on new data from two large clinical trials, the FDA required a black-box warning about an increased risk of leg and foot amputations.

As of October 2 017, there has not been a recall of Invokana related to kidney failure, amputations, myocardial infarction or ketoacidosis.

Lawsuit Allegations:

In December 2016, the U.S. JPML ordered consolidation of 55 Invokana cases in New Jersey federal court to be presided by Hon. Brian R. Martinotti, U.S.D.J, and Hon. Lois H. Goodman, U.S.M.J. By September 2017, this MDL- 2750 ( IN RE INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION JPML) reported nearly 800 lawsuits filed under it.

The first bellwether trial is scheduled for September 2018.

Evidences:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake
  • Any other SGLT2 inhibitors used

Medical Record Review and claim validation of Invokana case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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