The FDA just released more information on Invokana and Farxiga related to acute kidney failure. A topic and drug Childers, Schlueter & Smith have been investigating for a long time now.
Check out our: Top 10 Things Invokana Patients Need To Know…
As of June 14, 2016, the FDA released the following information on Invokana Injuries and other medications in its class:
ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
BACKGROUND: Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see Drug Safety Communication for the Data Summary). This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.
As recommended by the FDA: Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Read the patient Medication Guide you receive with your canagliflozin or dapagliflozin prescriptions. It explains the benefits and risks associated with the medicine.
As always, we urge health care professionals and patients to report side effects involving canagliflozin, dapagliflozin, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box and information: Report a Serious Problem to MedWatch
Complete and submit the report Online.
Download form 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
Again for patients suffering from acute renal/kidney issues or other complications while on Invokana, our law firm of Childers, Schlueter & Smith continues to investigate and review new Invokana injury claims on a daily basis. If you have questions, please give us a call to see how we can help. All initial inquiries are free of charge and without obligation.
*Invokana is a registered product of Janssen Pharmaceuticals and their other related corporate entities. Their interests are adverse to ours as a law firm representing patients suffering from potentially related injuries.