US FDA removes boxed warning from canagliflozin products
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US FDA removes boxed warning from canagliflozin products The prominent Boxed Warning regarding the risk of amputation with certain canagliflozin diabetes medicines is no longer present, advises the US FDA. In a recent Drug Safety Communication, the agency explained that based upon new data from three clinical trials, it has removed the above-mentioned Boxed Warning for canagliflozin (Invokana) and canagliflozin/metformin (Invokamet and Invokamet XR) products. Canagliflozin belongs to the class of medicines known as sodium-glucose cotransporter-2 (SGLT2 inhibitors), and it lowers blood sugar levels by causing the kidneys to remove sugar from the body via urine. The warning regarding an increased risk of leg and foot amputations was originally added in 2017 after the FDA considered all of the available data.* The FDA noted that subsequent reviews of new clinical trial data "demonstrated additional heart- and kidney-related benefits, which led to additional approved uses" in 2018 and 2019. The agency added that in its current review, "safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored". Although the Boxed Warning has been removed, the risk of amputation is still described in the "Warnings and Precautions" section of the prescribing information. The FDA concluded that "health care professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines". * see Reactions 1653 p4; 803245903 US Food and Drug Administration. FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). Internet Document : 26 Aug 2020. Available from: URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg803500431 and-foot-amputations-diabetes-medicine-canagliflozin
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Reactions 5 Sep 2020 No. 1820
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