Safety Warning for Canagliflozin Drugs
May 19, 2017 – The U.S. FDA has revised a Safety Communication previously issued in 2016 for Invokana®, Invokamet® and Invokamet® XR which are sodium-glucose cotransporter-2 (SGLT2) inhibitors, (canagliflozin) used to treat type 2 diabetes. Based on new information from ongoing clinical trials, the three FDA-approved drugs containing canagliflozin must now include a boxed warning alerting patients to the increased risk of foot and leg amputation associated with using canagliflozin.
Although the risk is still very small—less than one affected patient per 1,000—participants taking canagliflozin in the CANVAS and CANVAS-R studies had about twice the risk of needing an amputation, compared to patients taking an inactive placebo. Whether other SGLT2 inhibitors have similar risks is not yet known. The FDA cautions physicians to review patient histories for peripheral vascular disease, or any other conditions that might predispose individuals to amputations, before prescribing canagliflozin. Doctors should monitor all patients taking canagliflozin, and consider a different drug if patients have diabetic nephropathy, foot ulcers or any other complication that might result in amputation. Current canagliflozin patients are advised to continue taking the drug as prescribed, but to report immediately any pain, sores or infections on their feet or legs.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.