In May, 2015, the U.S. Food and Drug Administration (FDA) announced that it would conduct a safety review of sodium-glucose cotransporter-2 (SGLT2) inhibitors, such as Invokana, used to treat type 2 diabetes. The Agency announced the results of the review on December 4. SGLT2 inhibitors will now carry new warnings about the risks of ketoacidosis and serious urinary tract infection. The study reviewed adverse event reports to the FDA from March 2013 to May 2015.
Ketoacidosis is a life-threatening condition in which there is too much acid in the blood. The FDA safety review found 73 cases of ketoacidosis in patients taking SGLT2 inhibitors. All of the affected patients had to be hospitalized or treated in an emergency room.
The FDA says the actual number of people who developed ketoacidosis while taking SGLT2 inhibitors is probably higher because it the database it reviewed only includes cases that are actually reported to the FDA.
Life-Threatening Urinary Tract Infections
Urinary tract infection (UTI) may not sound dangerous, but it can progress to the point that it is life-threatening or fatal. The FDA’s safety review identified life-threatening blood infections and kidney infections in SGLT2 inhibitor users, all of which started as UTIs. All of the affected patients were hospitalized. Some were treated in intensive care units (ICU) or required dialysis for kidney failure.
If you have been harmed by a diabetes drug, please talk to an experienced defective drug attorney right away to learn more about your rights.