FDA: Amputation risk boxed warning removed from canagliflozin
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The FDA has removed from the prescribing information for the SGLT2 inhibitor canagliflozin a caution about increased leg and foot amputations among adults with type 2 diabetes taking the drug, according to a press release.
The boxed warning was issued in a 2017 safety alert for canagliflozin (Invokana, Invokamet and Invokamet XR; Janssen).
“The risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, FDA has concluded that the boxed warning should be removed,” the agency stated.
Health care providers should continue to counsel proper foot care and be alert to new pain, ulcers or infections of the feet and legs for adults with diabetes prescribed canagliflozin, according to the release.
Canagliflozin is approved to help manage glucose levels for adults with type 2 diabetes; to reduce the risks for major cardiovascular events or death among adults with type 2 diabetes and known heart disease; and to reduce the risks for end-stage renal disease, worsening of kidney function, CV death and hospitalization for heart failure among adults with type 2 diabetes and diabetic kidney disease.
The FDA encourages health care professionals and patients to report adverse events or adverse effects related to the use of canagliflozin to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 800-332-1088 to request a reporting form.
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