FDA Warning On SGLT-2 Drugs Raises Specter Of Labeling Change
This article was originally published in The Pink Sheet Daily
FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
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FDA strengthens warning about risk of acute kidney injury for two SGLT2 inhibitors but not Jardiance, the only diabetes drug with data on cardiovascular benefit.
Sponsors must also conduct another post-marketing study.