W&L is now accepting cases of diabetic ketoacidosis that resulted in the hospitalization or death of people who ingested any of the sodium glucose cotransporter-2 (SGLT2) inhibitors.
SGLT2 inhibitors are a class of medications indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
This drug class includes the medications:
- Xigduo XR
FDA Issues SGLT2 Inhibitor Safety Announcement
The U.S. Food and Drug Administration (FDA) on May 15, 2015 issued a Safety Announcement regarding several adverse event reports in which patients suffered from diabetic ketoacidosis while taking an SGLT2 inhibitor.
The FDA notes in its Safety Announcement that, unlike “typical” cases of diabetic ketoacidosis, those reported in patients taking an SGLT2 inhibitor occurred predominantly in type 2 diabetics whose blood sugar levels, when reported, were only slightly elevated.
This stands in contrast to the markedly elevated blood sugar levels often observed in diabetic ketoacidosis occurring in type 1 diabetics.
The FDA is investigating this emerging safety signal, and will determine whether labeling changes are needed for the SGLT2 inhibitors.
In addition to the FDA’s Safety Announcement, there are reports in the medical literature describing patients with diabetic ketoacidosis occurring in conjunction with the SGLT2 inhibitors.
A case series recently published online in the journal Diabetes Care details nine cases of patients developing diabetic ketoacidosis while taking canagliflozin. Three of the patients had a recurrence after their initial treatment, when they restarted taking the drug.
Like the cases discussed in the FDA’s Safety Announcement, these patients had uncharacteristic “euglycemic” diabetic ketoacidosis, in which their blood sugar levels were relatively normal.
The FDA’s counterpart in Europe reports similar occurrences and has launched its own review of SGLT2 inhibitors. The European Medicines Agency (EMA) states that, worldwide as of May 19, 2015, there were 101 patients who developed diabetic ketoacidosis while being treated with an SGLT2 inhibitor for type 2 diabetes.
Each of those cases was described as serious. Some required hospitalization, the EMA reported.
SGLT2 Inhibitors and Type 2 Diabetics
According to their approved indication, SGLT2 inhibitors can help blood sugar control when used in addition to diet and exercise. These medications cause the kidneys to purge glucose via urine.
SGLT2 inhibitors are approved in the U.S. as single-active ingredient products or in combination with other diabetes medicines.
The FDA has approved SGLT2 inhibitors for patients with type 2 diabetes. This class of medication is not approved for patients with type 1 diabetes.
The FDA states in its Safety Announcement that 20 cases of acidosis classified as diabetic ketoacidosis, ketoacidosis or ketosis in patients treated with SGLT2 inhibitors were reported to its Adverse Event Reporting System (FAERS) between March 2013 and June 6, 2014. The agency has continued to receive additional FAERS reports.
These 20 patients required emergency treatment or hospitalization, the FDA states.
The cases reported to the FDA reveal that the median time to onset of symptoms following initiation of an SGLT2 inhibitor was two weeks, but some cases occurred in as little as one day or as long as 175 days, according to the FDA.
The FDA explains that acidosis is a condition that occurs when the body contains too much acid. “Diabetic ketoacidosis and ketoacidosis are serious conditions in which the body produces high levels of blood acids called ketones,” the FDA indicates.
These ketones can accumulate and potentially introduce a risk of great harm, the FDA states.
Diabetic ketoacidosis associated with SGLT2 inhibitors may occur in an uncharacteristic way, with blood sugar levels only slightly elevated rather than high, the FDA explains.
According to the FDA, besides ketoacidosis, other possible side effects of SGLT2 inhibitors include:
- Elevated blood cholesterol
- Yeast infections
- Kidney problems
- Low blood sugar when combined with other medicines used to treat diabetes
Victims of SGLT2 Inhibitors Should Contact W&L
W&L of counsel attorney Ellen Relkin said “We are interested in talking to type 2 diabetics who took SGLT2 inhibitors and then suffered diabetic ketoacidosis requiring hospitalization.”
Ms. Relkin added that W&L also is interested in talking to the surviving spouses or relatives of type 2 diabetics who took an SGLT2 inhibitor and died as a result of diabetic ketoacidosis.
To speak with an attorney, complete and submit the form or telephone W&L toll-free at (877) 566-0055.