What’s the Problem?
Side effects of the type 2 diabetes medication Jardiance (generic: empagliflozin) may include diabetic ketoacidosis, kidney failure, heart attack, bone fractures and more.
What is Jardiance
Jardiance is a once-daily oral medication used to control blood sugar levels in patient with type 2 diabetes. It belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors that work by helping the kidneys excrete glucose from the bloodstream. Jardiance is manufactured by Boehringer Ingelheim, and was approved by the U.S. Food & Drug Administration (FDA) in August 2014.
SGLT2 Inhibitors May Cause Diabetic Ketoacidosis, FDA Warns
FDA warned in May 2015 that the entire class of SGLT2 inhibitor diabetes drugs may increase the risk of diabetic ketoacidosis (DKA), a life-threatening condition that requires hospitalization to treat. A search of the FDA Adverse Event Reporting System database found at least 20 cases reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. As a result of these problems, FDA in December 2015 required the labeling of all SGLT2 inhibitors to be updated with a warning about ketoacidosis and urinary tract infections (UTIs).
Diabetic ketoacidosis occurs when molecules called “ketones” build up in the blood, increasing the blood’s acidity. Ketones are normally made by the liver during fasting or low carbohydrate diets, and are used by cells as energy to replace glucose.
When there are too many ketone bodies in the bloodstream for the cells to use, the body tries to excrete them through the urine, which can lead to dehydration, hypotension and tachycardia, conditions that require hospitalization and can lead to death. Signs and symptoms of ketoacidosis include:
- Trouble breathing
- Abdominal pain
- Confusion or difficulty concentrating
- Unusual fatigue or sleepiness
- Dry or flushed skin
Jardiance helps prevent high blood sugar levels by forcing the kidneys to remove glucose from the body in urine. Experts are concerned that long-term treatment with Jardiance could lead to kidney failure via dehydration and urinary tract infections (UTIs). The Prescribing Information for Jardiance recommends that patients should have their kidney function monitored before starting treatment and periodically thereafter.
Jardiance Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Metabolic Acidosis, Ketoacidosis)
- Kidney failure
- Heart Attack (Myocardial Infarction or MI)
- Kidney Stones
- Bone Fractures / Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
- Yeast Infections (both men and women)
- And more
Mar 2013 – Application submitted
March 29, 2013 – Boehringer Ingelheim, Eli Lilly submit New Drug Application (NDA) for empagliflozin.
Mar 2014 – Response letter issued
March 5, 2014 – FDA issues complete response letter for empagliflozin.
Jun 2014 – NDA resubmission announced
June 17, 2014 – Boehringer and Lilly announce resubmission of NDA for empagliflozin.
Aug 2014 – Approved by the FDA
August 1, 2014 – Jardiance approved by the FDA.
May 2015 – FDA warning
May 15, 2015 – FDA warns of an increased risk of diabetic ketoacidosis (DKA) with SGLT2 inhibitor diabetes drugs.
Dec 2015 – Labels updated
December 4, 2015 – SGLT2 inhibitor labels updated with ketoacidosis warning.
Jun 2016 – FDA advisory committee recommendation
June 28, 2016 – FDA advisory committee recommends approval of Jardiance for cardiovascular indications.
- “Jardiance Prescribing Information”. U.S. Food & Drug Administration (FDA). August 2014.
- “FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood”. U.S. Food & Drug Administration. May 5, 2015.
- “FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections”. U.S. Food & Drug Administration (FDA). December 4, 2015.
- “ISMP QuarterWatch Report”. Institute for Safe Medication Practices (ISMP). January 13, 2016.
- “Jardiance Approval History”. Drugs.com.