FDA Increases Warnings on SGLT2 Inhibitor Medicines for Type 2 Diabetes
–FDA MedWatch SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
On December 4, 2015, after a review of the FDA Adverse Event Reporting Systems (FAERS) database the FDA (U.S. Food and Drug Administration) released a “Drug Safety Communication” announcing that it will require certain type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors, to contain warnings and other safety information regarding the risk of too much acid in the blood (ketoacidosis) and serious urinary tract infections.
SGLT2 inhibitors are a class of drugs that are approved for use by the FDA to help lower blood sugar levels in adults with type 2 diabetes. Common SGLT2 drugs include canagliflozin, dapagliflozin, and empagliflozin. The FDA’s review of reports from March 2013 to May 2015 found 73 cases of ketoacidosis relating to SGLT2 use. A similar review of reports from March 2013 to October 2014 identified 19 cased of life-threatening blood infections (that started as urinary tract infections), which required hospitalization.
Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. The FDA suggest that those taking a SGLT2 inhibitor and have any symptom of ketoacidosis should discontinue the medications use and seek medical attention immediately.
See the FDA Drug Safety Commuication
If you or a loved one suffered injuries that you believe were caused by a sodium-glucose cotransporter-2 (SGLT2) inhibitors , contact one of the experienced dangerous drug attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.