FDA Warning on Invokana and Invokamet
May 18, 2016 – The U.S. Food and Drug Administration (FDA) issued a warning that Janssen’s Invokana® (canagliflozin) and Invokamet® (canagliflozin/metformin) may be associated with an increased risk for foot, leg and toe amputations among patients using them. Mid-term results from an ongoing clinical study showed that more patients taking canagliflozin needed amputations than patients taking an inactive placebo. However, a second study did not find the same risk. Patients in the first trial have been treated for an average of four and one-half years; patients in the second one only have been treated for nine months, on average. Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that treats type 2 diabetes. The FDA does not have enough information to draw solid conclusions and is not requesting label changes, at this time, but it will evaluate additional information from the trials. Patients are being warned to let their healthcare professionals know right away about any unusual infections, numbness, pain or sores involving their feet or legs. Prescribers are advised to monitor canagliflozin patients carefully for any signs of foot or leg problems.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 1-800-FDA-0178
Actual drug patent expiration dates and a 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.