A consumer advocacy is urging the Food and Drug Administration to heighten warnings about a widely prescribed group of diabetes drugs known as SGLT-2 inhibitors, due to hundreds of cases of a potentially fatal reaction among people with type 1 diabetes, even though the medicines are not approved for those patients.
In a citizen’s petition being filed with the agency on Wednesday, Public Citizen argued that a “black box” warning, the most serious safety warning found in prescription drug labeling, should note SGLT-2 inhibitors can cause ketoacidosis. This is a serious complication of diabetes that occurs when the body produces high levels of blood acids called ketones and develops when the body fails to produce enough insulin.
The SGLT-2 inhibitors are approved for type 2 diabetics and were also studied for use in type 1 diabetes, although never approved by the FDA for that group of patients. Nonetheless, Public Citizen noted some physicians have prescribed the drugs to type 1 diabetics. Since 2013, 550 reports of ketoacidosis tied to the drugs were filed with the FDA. Of those, 411 cases were hospitalized and 68 were considered life-threatening.
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