Invokana FDA Warnings

Portner & Shure Law Firm Serving Maryland, Virginia & Washington D.C.


Over the last several years, the U.S. Food and Drug Administration (“FDA”) has required a significant number of changes to the warnings labels for the Type II diabetes medication, Invokana, after studies showed substantial risk of adverse health complications. Invokana (Canagliflozin) is used to lower blood sugar by causing the kidneys to remove sugar from the body through the urine. The following are a list of several updates to the warning labels that address the various risks associated with Invokana:

September 10, 2015: The FDA issued a safety announcement revising the label for Invokana to include a warning on the risk of bone fracture and decreased bone mineral density after studies showed an increased risk of bone fractures as early as 12 weeks after starting Invokana.

December 4, 2015: The FDA published a safety announcement ordering the addition of diabetic ketoacidosis warnings to all Invokana labels after a safety review of the medication showed a substantial risk of this medical condition. Diabetic Ketoacidosis is a serious and dangerous condition in which the body produces high levels of blood acids called ketones.  Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, trouble breathing, and urinary tract infections.

June 14, 2016: The FDA produced another safety announcement requiring additional health warnings on Invokana labels as studies revealed a harmful risk of kidney injury and acute kidney failure. Studies showed over 100 patients suffering from acute kidney failure requiring hospitalization and dialysis. Acute kidney failure is a serious problem as it causes the kidneys to suddenly stop working which creates a build-up of dangerous levels of waste in the body.

May 16, 2017: The FDA issued a new requirement for Invokana labels to include warnings about the increased risk of amputations. The FDA found a high risk of leg and foot amputations after finding 7.5 out of every 1,000 patients treated with a Canagliflozin drug for Type II Diabetes Mellitus, such as Invokana, were exposed to a risk of amputation. The warning was to inform patients to notify their doctors right away if they experienced new pain or tenderness, sores or ulcers, or infections in legs or feet. The FDA found that amputations of patients’ toes and feet were common but also acknowledged that some patients were forced to undergo multiple amputations

            Despite the above mentioned risks, companies like Johnson and Johnson, have consistently profited millions of dollars while many people continue to suffer.

If you've used Invokana to treat type 2 diabetes and experienced any of the above adverse health problems, contact our highly-skilled drug injury lawyers today at one of our offices in Maryland at 410-995-1515 or 301-854-9000, in Virginia at (703) 734-8790, or in Washington, D.C. at 202-554-1449 for your free consultation.

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