The U.S. Food and Drug Administration (FDA) has added warnings to the labels of a specific class of type 2 diabetes medicines, after a safety review showed it may lead to having too much acid in the blood and serious urinary tract infections.

Sodium-glucose cotransporter-2, or SGLT2 inhibitors, refers to a class of prescription medicines that FDA approved to lower blood sugar in adults with type 2 diabetes. It is not, however, approved by the agency for use in patients with type 1 diabetes.

“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones,” the FDA stated in its statement.

According to the agency, ketoacidosis is characterised by nausea, vomiting, abdominal pain, tiredness and having trouble in breathing.

Urinary tract infection, on the other hand, may be indicated with symptoms such burning sensation when urinating or the need to urinate often or right away, pain in the lower part of the stomach area or pelvis, fever or blood in the urine.

The FDA first warned about the risk of ketoacidosis and its association with SGLT2 inhibitors in May 2015, noting that it would continue to evaluate the safety issue.

Upon reviewing its database from March 2013 to May 2015, the agency has identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors. All these patients required hospitalisation or treatment in an emergency department, the FDA reported.

“In many cases, ketoacidosis was not immediately recognised because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases,” the FDA noted.

The agency also found 19 cases of life-threatening blood infections and kidney infections that started as urinary tract infections, which were associated with the SGLT2 inhibitors. The patients were hospitalised, with some even admitted to an intensive care unit or dialysis in order to treat kidney failure.

“As a result, we have added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations,” the FDA said.

The agency is also requiring manufacturers of SGLT2 inhibitors to conduct a required post-marketing study among patients treated with SGLT2 inhibitors, including specialised follow-up to collect additional information, for a period of five years.

“We urge health care professionals and patients to report side effects involving SGLT2 inhibitors to the FDA MedWatch program,” the FDA added.

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