Safety Communication Update on Invokana/Farxiga
June 13, 2016 – The U.S. Food and Drug Administration (FDA) followed up on another previous Safety Communication that it is requiring stronger warnings for the sodium-glucose cotransporter-2 (SGLT2) inhibitors, Invokana® (canagliflozin), Farxiga™ (dapagliflozin) and their combination products, Invokamet® (canagliflozin/metformin) and Xigduo™ XR (dapagliflozin/metformin extended release).
All four medications are indicated to treat type 2 diabetes. Over about two and a half years, the FDA verified at least 100 cases of acute kidney injury (AKI) among patients taking one of the drugs. Most recovered at least partly after the drug was stopped, but four patients died and several others had to undergo dialysis. Labeling for the drugs now includes advice for patients to report any signs of AKI, such as decreased urine output or swollen legs, to their doctors. Prescribers are cautioned to assess kidney functioning before prescribing one of the drugs and then to reassess patients regularly, watching for any possible AKI symptoms.
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.