Doctors Urge Caution In Interpreting FDA’s SGLT2 Warning
Endocrinologists raise concerns over FDA case reports because diabetic ketoacidosis may be a risk for type 1 diabetes patients taking SGLT2 inhibitors, but it is very rare in type 2 diabetes.
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FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect the pancreas.
Commercial impact on the top-selling insulin is questionable, as 2009 studies showing the risk had already been seen as sketchy and did not appear to dent sales or competitive profile.