What Is Invokana?
Invokana is the brand name for the prescription drug canagliflozin, manufactured by Janssen Pharmaceuticals, a unit of Johnson & Johnson. Janssen markets Invokana as “a once-daily pill that works around the clock to lower blood sugar.” It is intended to help reduce blood sugar levels in adults suffering from type 2 diabetes. Invokana has not been approved for use in children under the age of 18, nor is it for use by individuals with type 1 diabetes.
How Does Invokana Work?
According to Janssen, “Invokanna works with your kidneys to help you lose some sugar—about 100 grams a day—through the process of urination.” Classified as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, Invokana inhibits the kidneys’ ability to reabsorb glucose (and then pass it back into the bloodstream), resulting in the kidneys’ expelling more glucose in urine than they would naturally.
How Is Invokana Taken?
Invokana is taken orally by pill once daily prior to the first meal of the day and should be taken at about the same time each day. Invokana has been approved in 100 mg and 300 mg doses.
What Is Invokamet?
Invokamet is a combination product also manufactured by Janssen Pharmaceuticals. It contains canagliflozin (Invokana) and metformin and therefore shares many risks and side effects with Invokana. Invokamet is one of a new wave of so-called “combination” drugs.
AN EVER-INCREASING RISK
THE HISTORY OF THE INVOKANA LABEL
The history of the FDA-approved Invokana label is just one example of how excruciatingly difficult it can oftentimes be for patients seeking complete, clear, unbiased information on which to base important health-care choices. Over the course of four years following Invokana’s approval, with reports of adverse reactions pouring in from doctors and patients across the country, the FDA continually and regularly revised the Invokana label, expanding and updating the list of “Warnings and Precautions” associated with the drug as more and more apparent side effects came to light. Whereas the original March 2013 label contained 7 bullet points of such warnings, by July 2017 that number had grown to 11, an increase of nearly 60%.
FDA Label Modifications For Invokana
March 2013: The United States Food and Drug Administration (FDA) approved Invokana (canagliflozin) for sale in 100 mg and 300 mg tablets. In the Summary Review of its decision, the FDA Center for Drug Evaluation and Research described Invokana as “a first-in-class anti-diabetic therapy employing a novel mechanism of action that is not dependent upon insulin release or improving insulin sensitivity.” The initial FDA-approved label for Invokana contained warnings for 7 items: hypotension, impairment of renal function, hyperkalemia, hypoglycemia, genital mycotic infections, hypersensitivity (allergic) reactions, and increased LDL-C, but—conspicuously in retrospect—no mention of acute kidney damage, ketoacidosis, or lower limb amputation.
Increasing Risk...September 2015: The FDA issued an “Efficacy-Labeling Change With Clinical Data” for Invokana. For the first time, the “Warnings and Precautions” section on the Invokana label contained a bullet point for “Bone fracture” with additional information detailing reductions in bone density that had been observed in association with Invokana use. The warnings still contained no mention of acute kidney damage, ketoacidosis, or lower limb amputation.
Increasing Risk...December 2015: A further label update added ketoacidosis, urosepsis, and pyelonephritis to the list of “Warnings and Precautions”, which was growing quickly as post-market data about Invokana’s serious side effects continued to pour in. But still no mention of acute kidney damage or lower limb amputation.
Increasing Risk...May 2016: The “Impairment in renal function” warning on the Invokana label was expanded and upgraded to become “Acute kidney injury and impairment in renal function” (emphasis added) based on a growing body of evidence associating Invokana with serious kidney damage. But still no mention of lower limb amputation.
Increasing Risk...July 2017: More than four years after Invokana’s original FDA approval, the FDA issued yet another revision to the drug’s label, this time requiring a so-called “black-box warning”—the FDA’s highest level of warning—for a risk that had never before appeared in Invokana’s “Warnings and Precautions” section: lower limb amputation.
The FDA’s new label read as follows:
Warning: Lower Limb Amputation
See full prescribing information for complete boxed warning.
• In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, INVOKANA has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg (5.1)
• Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving INVOKANA for infections or ulcers of the lower limbs, and discontinue if these occur. (5.1)”
Invokana and the FDA
The history of the FDA-approved Invokana label tells in microcosm the tale of a pharmaceutical industry so driven by perverse incentives like maximizing shareholder value and meeting quarterly earnings targets that it is willing to use the American public as human guinea pigs, raking in billions as sick people looking for help fork over their hard-earned money for medicine that they hope will make their health better, not worse.
The experienced attorneys at TheLawFirm.com are experts in using the legal system to defend the rights of patients and their loved ones against the negligence and misdeeds of Big Pharma. When you stand up for your rights, you not only give yourself a chance at getting the justice and compensation you deserve, you become another person standing up against Big Pharma, letting them know that there will be a literal price to pay when they bring unsafe and untested products to market, speaking to them in the only language they understand: money.
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Sources: US National Library of Medicine, MedlinePlus, “Canagliflozin” Invokana Website US FDA Center for Drug Evaluation and Research – Summary Review, “Invokana” Invokana – March 2013 FDA-Approved Label Invokana—September 2015 FDA-Approved Label Invokana – December 2015 FDA-Approved Label Invokana – May 2016 FDA-Approved Label Invokana – July 2017 FDA-Approved Label