The FDA approval of a new combination medication should soon bring type 2 diabetes patients a new treatment option.
The US Food and Drug Administration (FDA) Friday approved Synjardy (empagliflozin and metformin hydrochloride) to treat type 2 diabetes in adults. The Boehringer Ingelheim and Eli Lilly drug is the third containing empagliflozin to receive FDA approval. The other two are Glyxambi and Jardiance.
Synjardy was approved as a complement to exercise and healthy diet to help control blood sugar in type 2 diabetes patients. In type 2 diabetes, the body does not produce enough insulin, the hormone that regulates blood sugar. As a result, blood sugar is often high in these patients. Uncontrolled type 2 diabetes has been linked to heart and kidney disease, among other health problems.
This combination drug was approved for use in patients who have not seen results with metformin or empagliflozin alone.
Because it contains metformin, Synjardy carries a boxed warning noting a heightened risk of lactic acidosis for patients taking this drug. Lactic acidosis is a buildup of lactic acid in the bloodstream that causes symptoms like weakness and nausea.
According to a company press release from Eli Lilly and Boehringer Ingelheim, Synjardy received FDA approval after clinical trials found that the drug appeared safe and effective.
Potential serious side effects of Synjardy include low blood sugar, dehydration, kidney problems, and urinary tract and yeast infections. Common side effects include diarrhea, nausea, vomiting and sore throat, among others.