Brand Names of Popular SGLT2 Inhibitors
What Interacts with SGLT2
Three SGLT2 inhibitors approved by the FDA include canagliflozin, dapagliflozin and empagliflozin:
Canagliflozin is marketed under the brand name Invokana. It is manufactured by Janssen Pharmaceuticals and was approved by the FDA on March 29, 2013.
Dapagliflozin is marketed under the brand name Farxiga. It is manufactured by AstraZeneca and was approved by the FDA on Jan. 8, 2014.
Empagliflozin is marketed under the brand name Jardiance. It is distributed by Boehringer Ingelheim, marketed by both Boehringer Ingelheim and Eli Lilly, and was approved by the FDA on Aug. 1, 2014.
SGLT2 inhibitors belong to the gliflozin class of prescription medicines. The FDA has approved seven formulations of gliflozins, recommonded for use with diet and exercise to help lower blood sugar in adults with type 2 diabetes mellitus. SGLT2 inhibitors are intended to be used to help lower blood sugar by deterring the reuptake of glucose in the kidneys, preventing this glucose from reentering the bloodstream, instead causing it to be expelled from the body through urination.
SLGT2 inhibitors are available as single-active ingredient medicines but also may be combined with other diabetes medicines.
SGLT2 inhibitors may be taken alone or as a combination therapy with other antidiabetic medicines:
- Canagliflozin and metformin is marketed under the brand name Invokamet. It is manufactured by Janssen Pharmaceuticals and the FDA approved Invokamet on Aug. 8, 2014.
- Dapagliflozin and metformin extended-release is marketed under the brand name Xigduo XR. It is manufactured by AstraZeneca and was approved by the FDA on Oct. 29, 2014.
- Empagliflozin and linagliptin is marketed under the brand name Glyxambi. It is distributed by Boehringer Ingelheim, marketed by both Boehringer Ingelheim and Eli Lilly, and was approved by the FDA on Jan. 30, 2015.
- Empagliflozin and metformin is marketed under the brand name Synjardy. It is distributed by Boehringer Ingelheim, marketed by both Boehringer Ingelheim and Eli Lilly, and was approved by the FDA on Aug. 26, 2015.
SGLT2 Inhibitor Contraindications
What Interacts with SGLT2
Medicines that may adversely interact with SGLT2 inhibitors include:
SGLT2 inhibitors are indicated for use with diet and exercise in adults with type 2 diabetes mellitus to improve control of blood sugar levels.
They are not approved for use by the FDA in people with type 1 diabetes mellitus, or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). Also, SGLT2 inhibitors are contraindicated if you have a known allergy to SGLT2 inhibitors, severe kidney problems, or need for dialysis.
Interactions with Other Drugs
In the course of treatment with SGLT2 inhibitors, your doctor may decide to treat you with additional medicines. However, doing so may raise the risk that you could experience SGLT2 injuries due to the interactions that can occur when different drugs are taken together.
Consult your physician before taking multiple medications. Inform your physician of any medications, both prescription and over-the-counter, that you are taking. This includes nutritional supplements used for diabetes.
The FDA Investigates Diabetic Ketoacidosis Link
The U.S. Food and Drug Administration (FDA) issued a Safety Announcement regarding SGLT2 inhibitors on May 15, 2015. 6 One month later, the European Medicines Agency (EMA) announced that it had initiated an investigation into the risk of diabetic ketoacidosis with SGLT2 inhibitors. 7 In June 2015 Health Canada began a safety review of SGLT2 inhibitors and the risk side effects as well. 8 While there have been reports of SGLT2 inhibitor injuries, no recall of the drugs has been issued in the U.S. or any other country.
Between March 2013 and June 6, 2014, 20 such cases were reported through the FDA’s Adverse Event Reporting System database. All 20 required emergency room visits or hospitalization. Such cases have continued to be reported to the FDA since then, although the agency has not specified how many. 9
The EMA’s decision to investigate the risk for diabetic ketoacidosis with SGLT2 inhibitors was prompted by adverse event reports to the EMA’s EudraVigilance indicating that, as of May 19, 2015, more than 100 people who had taken SGLT2 inhibitors with type 2 diabetes suffered diabetic ketoacidosis serious enough that many of those patients required hospitalization. 10
Meanwhile, a growing body of scientific evidence regarding diabetic ketoacidosis in patients taking SGLT2 inhibitors supports the safety concerns of the FDA, EMA and Health Canada.
On December 4, 2015, the FDA safety review prompted the addition of warnings to all SGLT2 inhibitor labels regarding the risk of diabetic ketoacidosis. In addition, the FDA added warnings regarding the risk of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections in people taking SGLT2 inhibitors. 11