The warnings will address 2 issues: the risk of too much acid in the blood and severe urinary tract infections.
The FDA today added warnings to labels of sodium glucose co-transporter-2 (SGLT2) inhibitors, a class of type 2 diabetes therapy that has been on the market since 2013. The drugs work through a unique mechanism of action that all clears glucose through from body through the urine.
The label change will inform patients of the risk of too much acid in the blood, as well as serious urinary tract infections (UTIs). In May, FDA issued a safety communication about the potential risk of ketoacidosis with the SGLT2 class and said the agency would continue to evaluate the issue. That step was based on a review of incidents reported to the FDA Adverse Events Reporting System (FAERS) database from March 2013 to May 2015.
FDA also identified 19 cases of blood infections and kidney infections that started as UTIs that were deemed life-threatening, meaning the patients required hospitalization, with a few requiring time in intensive care or dialysis to treat kidney failure.
The new warnings and precautions will advise patients of these 2 safety issues. The labels will advise patients to stop taking SGLT2 inhibitors if they have symptoms of ketoacidosis and seek medical attention immediately.
FDA will also require manufacturers of the SGLT2 inhibitor class to conduct a pharmacovigilance study for a period of 5 years. This involves specialized follow-up of reports from patients with ketoacidosis who were treated with the drugs.
In addition to treating type 2 diabetes, SGLT2 inhibitors have been shown to be effective in treating hypertension; this often allow clinicians to reduce or eliminate diurectics in patients, thus reducing overall side effects. Some patients also experience modest weight loss while taking the drug. Current clinical trials are examining the effectiveness of the drug class in treating patients with type 1 diabetes.
One drug in the class, empagliflozin, has been shown to have some cardioprotective benefits, the first of the newer diabetes therapies to have this effect.