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FDA Black Box Invokana Warning

In May 2017, the Food and Drug Administration (FDA) issued its strictest warning available—the black box warning—against the diabetic drug Invokana. Invokana is the trademark name for canagliflozin, an SGLT2 inhibitor that lowers a patient’s blood sugar level.

The drug, which is manufactured and marketed by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, won FDA approval in March 2013. Before a drug is granted approval by the FDA, it is supposed to be thoroughly tested to make sure that it is safe.

Testing is also required to find any side effects the drug may cause. If there are risks discovered, it is the manufacturer’s responsibility to make sure that both doctors and patients are fully aware of those risks.

Shortly after it won federal approval, doctors and researchers raised serious concerns about Invokana regarding whether use of the drug led to an increased risk for lower limb amputations and acute kidney injuries. These concerns lead the FDA to conduct its own investigation. If you would like to know more about the FDA black box Invokana warning or you have sustained complications due to Invokana use, speak with a capable Invokana lawyer today.

FDA Investigation Results

The conclusion of the FDA was that Invokana did put patients at risk for multiple potential injuries. It ordered Janssen to include the following known risks in their product literature and packaging.

  • Amputations: Invokana increases the risk of toe, foot, and leg amputations, particularly in those with history of vascular disease and neuropathy
  • Bone Fractures: It has been observed that patients taking Invokana had a higher incidence of bone fractures
  • Genital Mycotic Infections: Invokana increases the risk that a patient will develop genital infections
  • Hyperkalemia: Potassium is critical to the function of nerve and muscle cells, including the heart. Too much blood potassium can be dangerous. Invokana can interfere with the ability of the body to excrete potassium
  • Hypersensitivity Reactions: Patients taking Invokana may develop serious hypersensitivity reactions within hours or days after starting the drug
  • Hypoglycemia: When taken with insulin, Invokana can increase the risk of hypoclycemia
  • Hypotension: Invokana can cause abnormally low blood-pressure
  • Impaired Renal Function: Invokana can impair the ability of the kidneys to properly function
  • Increases in Low-Density Lipoprotein (LDL): Invokana increases LDL, more colloquially known as bad cholesterol
  • Ketoacidosis: Invokana can cause muscle and other tissues to be broken down as a source of fuel, causing a buildup of acids in the blood called ketones. If left untreated, this can lead to diabetic ketoacidosis

Personal Injury Attorney is Available to Help

If you suffered or are suffering adverse effects or injuries as a result of being prescribed Invokana, consider contacting a dangerous drug attorney to find out what legal recourse you may have against Janssen Pharmaceuticals for the pain and losses you have sustained. A skilled attorney could answer any questions you may have about the FDA black box Invokana warning and could fight for you.