FDA Updates Warning Label on SGLT2 Inhibitor Class of Diabetes Drugs

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, comments on a recent label update involving sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of Type 2 diabetes drugs that includes canagliflozin (sold under the brands Invokana or Sulisent), dapagliflozin (sold under the brand Farxiga in the United States and Forxiga in the European Union), and empagliflozin (sold under the brand Jardiance). In an FDA Safety Announcement issued December 4, 2015, the U.S. Food and Drug Administration (FDA) announced that the labels are being revised to reflect the risk of too much acid in the blood (ketoacidosis) and of serious urinary tract infections (UTIs). The agency warned that both conditions may lead to hospitalization. Meanwhile, manufacturers of SGLT2 inhibitors are now also required to conduct a post-marketing study on these drugs and, in May 2015, the [FDA](http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery) issued a Drug Safety Communication concerning the risk of ketoacidosis.

The presence of ketones in the blood increases the blood's acidity and may lead to a condition known as ketoacidosis. According to the FDA announcement, symptoms of ketoacidosis include €œnausea, vomiting, abdominal pain, tiredness, and trouble breathing.€ The FDA conducted a review of its Adverse Event Reporting System (FAERS) database, which revealed 73 cases of ketoacidosis linked to SGLT2 inhibitor-use between March 2013 and May 2015. Hospitalization or emergency department treatment was required in all of these patients. The agency also noted that, €œIn many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.€

[The FDA's review](http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery) of SGLT2 inhibitors also identified 19 cases of UTIs that resulted in urosepsis (life-threatening blood infections) and pyelonephritis (kidney infections) between March 2013 and October 2014. According to the announcement, all patients required hospitalization and €œa few required admission to an intensive care unit or dialysis in order to treat kidney failure.€ The FDA notes that the symptoms of a UTI may include a burning sensation while urinating, the urge to urinate frequently or immediately, pain in the lower abdominal or pelvic area, fever, or blood in the urine.

€œBeing well-informed about adverse events associated with a drug reduces the risk of experiencing serious, life-changing side effects,€ said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman. €œThe firm is committed to relaying news involving drugs and medical devices, and will continue to keep consumers updated.€

For more information concerning drug reactions, please visit [Parker Waichman's Defective Drug page](http://www.yourlawyer.com/practice-areas/defective_drugs) on its website at http://www.yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO.

Company :-Parker Waichman LLP

User :- Parker Waichman

Email :-prc.pressagency@gmail.com

Phone :-516--46-6-6500

Mobile:- -

Url :- http://www.yourlawyer.com/long-island