FDA News: Jardiance Approval

December 2016

The FDA approved a new indication for Jardiance by Boehringer Ingelheim Pharmaceuticals, Inc., to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.

Death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes. Patients with diabetes have a decreased life expectancy due in large part to premature cardiovascular death.

Jardiance Approval

In a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.

Adverse Effects & Side Effects

  • Jardiance can cause dehydration and hypotension.
  • Jardiance can also cause increased ketoacidosis, serious urinary tract infection, acute kidney injury and impairment in renal function,.
  • Hypoglycemia when used with insulin or insulin secretagogues.
  • Genital mycotic infections, and increased cholesterol.
  • The most common side effects of Jardiance are urinary tract infections and female genital infections.

Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Jardiance is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.

Learn more here