Public Citizen, a consumer advocacy group, filed a citizen's petition June 24 urging the FDA to increase warnings on a group of commonly prescribed diabetes drugs called SGLT-2 inhibitors, as the drugs have shown to cause a potentially fatal reaction among people with Type 1 diabetes.
The drugs are only approved for Type 2 diabetes patients, but some physicians have prescribed the drugs to Type 1 diabetics, STAT reported.
The citizen's petition argues the FDA should require the drug labeling to include a black box warning, the most serious type of safety warning for prescription drugs. The labels should include a warning that SGLT-2 inhibitors can cause ketoacidosis in Type 1 diabetics, a serious complication of diabetes that causes the body to produce high levels of blood acids when the body fails to produce enough insulin, Public Citizen wrote.
Since 2013, 550 reports of ketoacidosis tied to the drugs have been reported to the FDA, according to STAT.
Public Citizen said the current labeling on the drugs are "grossly inadequate" and the warning should state the drugs shouldn't be used by Type 1 diabetics.
"The current dangerous off-label prescribing of these drugs to patients with Type 1 diabetes, which has been well documented by the FDA, is enabled by the dangerous incompleteness and submerged prominence of the warnings about the risk of [ketoacidosis] in the current product labeling," the petition states.
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