The US Food and Drug Administration (FDA) has updated the labels for sodium-glucose cotransporter 2 (SGLT2) inhibitors to include the risks for ketoacidosis and serious urinary tract infections. Both conditions can require hospitalization.
In May 2015, the FDA released a drug safety communication cautioning about the risk for ketoacidosis with SGLT2 inhibitors and saying the FDA would continue to study this issue.
From March 2013 to May 2015, the FDA received reports of 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes who were treated with SGLT2 inhibitors. Ketoacidosis symptoms include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing.
The FDA Adverse Event Reporting System also received reports of 19 cases of potentially fatal urosepsis and pyelonephritis that began as urinary tract infections in patients taking SGLT2 inhibitors from March 2013 through October 2014. Those 19 patients all required hospitalization, and some required intensive care unit admission or dialysis to treat kidney failure.
The new warnings and precautions in the labels of all SGLT2 inhibitors will address these safety issues and make prescribing and monitoring recommendations.
The FDA is also mandating that manufacturers of SGLT2 inhibitors conduct a postmarketing study that will require manufacturers to analyze spontaneous postmarketing reports of ketoacidosis in patients using SGLT2 inhibitors, including the collection of follow-up data for 5 years.
Patients who develop symptoms of ketoacidosis should stop taking their SGLT2 inhibitor and seek medical attention immediately, the agency said.
Healthcare providers should assess patients taking SGLT2 inhibitors for ketoacidosis and urinary tract infections if they present with suggestive symptoms, the FDA advised. Patients who take SGLT2 inhibitors can develop ketoacidosis even if their blood glucose is not excessively high. Patients in whom ketoacidosis is suspected should have their SGLT2 inhibitor use stopped and receive treatment promptly.
More information about today's warning is available on the FDA website.
The FDA encourages clinicians to promptly report adverse events with SGLT2 inhibitors to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA Adds Warnings to SGLT2 Inhibitors - Medscape - Dec 04, 2015.