Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitors Lead to Ketoacidosis (DKA) and Kidney Failure
SGLT-2 Inhibitors are a new class of type 2 diabetes drugs that are intended to be used in combination with diet and exercise to lower blood sugars in adults with type 2 diabetes. SGLT-2 Inhibitors were designed to assist in lowering blood sugars by working with the user’s kidneys to expel excess sugar through urination. Unfortunately, serious side effects have been linked to the use of these drugs, including kidney failure and ketoacidosis.
Some of the drugs that make up the SGLT-2 inhibitor class include Farxiga and Xigduo XR, which are manufactured and distributed by Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals, and Jardiance and Glyxambi, drugs that are manufactured and distributed by Boehringer Ingelheim Pharmaceuticals in conjunction with Eli Lilly and Company.
Facts about SGLT-2 Inhibitors:
- SGLT-2 Inhibitors make up a substantial part of the diabetes drug market and sales numbers for the drugs continue to grow. Farxiga posted $220 million in U.S. sales in Q3 2016, up 63% from the same timeframe in 2015 and 79% year to date over 2015.
- In May 2015, the FDA issued a warning that each of the drugs in the SGLT-2 inhibitor class had been linked with ketoacidosis, or DKA. The FDA issued this warning after receiving 20 adverse event reports between March 2013 and June 6, 2014 of patients being treated with an SGLT-2 inhibitor who required emergency room visits or hospitalization to treat ketoacidosis. The FDA said it had continued receiving additional adverse event reports for DKA and ketoacidosis since June 6, 2014, but did not give exact numbers. In many of these instances, the cases were not typical for DKA because the patients had type 2 diabetes (DKA is more common in persons with Type 1 diabetes) and also because their blood sugar levels were only slightly increased compared to typical cases of DKA, where the blood sugar levels are generally quite elevated.
- In December 2015, FDA required the manufacturers of SGLT-2 Inhibitors to add a warning about DKA to the drugs’ labels. Until that point, there was no warning about ketoacidosis or DKA on any of the SGLT-2 inhibitors’ labels.
- In June 2016, FDA required the manufacturers of certain SGLT-2 Inhibitors, including Farxiga and Xigduo XR, to add a warning about acute kidney failure.
If you or a loved one has used or is using an SGLT-2 inhibitor and have suffered from kidney failure or diabetic ketoacidosis (DKA), or you have lost a loved one for one of these reasons, find out how Johnson Becker, PLLC can help you. Please either call us at our toll free number, (800) 279-6386, or fill out our case review form here on our website and submit it for a free consultation.