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Drugs & Medical Devices

SGLT2 Clinical Research and Side-Effects

— May 19, 2015


The Food and Drug Administration’s (FDA) May 15th warning of potential ketoacidosis among Type II diabetes patients who use a new class of oral treatments known as SGLT2 inhibitors should not be completely surprising. The first such medicine approved by the FDA in March, 2013 was Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals in conjunction with Johnson & Johnson. Among the drug’s warnings was that it should not be used by Type I diabetes patients, people with excess ketones in their blood (ketoacidosis), or people undergoing dialysis. 9 clinical trials involving 10,285 people with type II diabetes also indicated a higher risk of vaginal yeast infections and urinary tract infections, especially among uncircumcised men, as well as hyperkalemia, a sickness caused by too much potassium in the blood. Scientists also warned that patients with renal failure should not take Invokana as well. The drug was also studied in combination with other Type II diabetes drugs like metformin, sulfonylurea, pioglitazone, and insulin.

Two other popular SGLT2 inhibitors were also approved in 2014, AstraZenica’s Farxiga (dapagliflozin) in January and Boehringer/Eli Lilly’s Jardiance (empagliflozin) in August. Clinical trials for Farxiga included two placebo-controlled monotherapy studies involving 840 patients, as well as multiple combination studies with metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Side-effects listed were similar to Invokana save hyperkalemia, and with addition of an increased risk for bladder cancer. In addition to the same warnings as with Invokana regarding Type I diabetes, ketoacidosis, and renal failure, the trials also revealed an increased risk in nasopharyngitis, the common cold. Jardiance was tested in 7 clinical trials involving 4,480 patients and in combination with metformin, sulfonylureas, pioglitazone, and insulin. Side effects found included dehydration, sudden drop in blood pressure, and dizziness/fainting (mostly due to the drop in blood pressure). Like the other drugs, Jardiance is not recommended for Type I diabetes patients, patients with a history of ketoacidosis, or people with renal failure.



American Pharmacists Association – Maria G. Tanzi


Food and Drug Administration – Press Release

Healthline News – Sandra Levy



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