Dive Brief:
- SGLT2 inhibitor type 2 diabetes medications can lead to ketoacidosis (build up of certain types of blood acids), which could lead to hospitalization, according to a new warning from the FDA.
- SGLT2 inhibitors help control blood sugar by causing sugar to be released through the urine in larger quantitites than normal.
- These newer medications, which are already widely used, are made by AstraZeneca (Farxiga-/dapagliflozin), Johnson & Johnson (Invokana/canagliflozin), and by Eli Lilly, which is partnered with Boehringer Ingelheim to co-market Jardiance (embagliflozin).
Dive Insight:
SGLT2 inhibitors, or sodium-glucose cotransporter-2 inhibitors, are a popular class of treatments for type 2 diabetes, because they not only have the intended hypoglycemic effect, but also lead to modest weight loss and a small decrease in blood pressure.
The warning from the FDA explains that "SGLT2 inhibitors can lead to ketoacidosis, which could lead to hospitalization" and that "DKA, a subset of ketoacidosis or ketosis in diabetic patients, is a type of acidosis that usually develops when insulin levels are too low or during prolonged fasting."
During a period of roughly 15 months, the FDA Adverse Event Reporting System logged a total of 20 cases of ketoacidosis in patients taking SGLT2 inhibitors—and in all cases, the patients had to be hosptialized. At this point, the FDA has committed to continuing to investigate this serious adverse event, but the warning is the only action that's been taken so far.
"We urge health care professionals and patients to report side effects involving SGLT2 inhibitors to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page," wrote the agency.