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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY December 2015 | Archived Issues

FDA Warns About SGLT2 Inhibitors, Contrast Media

Pharmacy Focus

A review by the U.S. Food and Drug Administration has resulted in additional warnings on the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Also, the FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine for X-rays and other medical imaging procedures. 


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FDA Warns About SGLT2 Inhibitors, Contrast Media

Pharmacy Focus

FDA: SGLT2 Inhibitors Can Lead to Serious Complications

A safety review by the U.S. Food and Drug Administration has resulted in additional warnings on the labels of a specific class of Type 2 diabetes medicines — sodium-glucose cotransporter-2 (SGLT2) inhibitors — about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.

The FDA warned in May about the risk of ketoacidosis with SGLT2 inhibitors. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness and trouble breathing.

The agency also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.

For more information, click here.

FDA: Contrast Agents May Lead to Underactive Thyroid in Some Infants

The FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects.

For more information, click here.