The U.S. Food and Drug Administration (FDA) is warning the type 2 diabetes medications canagliflozin, dapagliflozin, and empagliflozin could trigger a serious condition.
The drugs have been linked to ketoacidosis, which causes the body to produce high levels of blood acids, potentially leading to hospitalization.
These types of drugs are called SGLT2 inhibitors and are FDA-approved for the use of lowering blood sugar in combination with diet and exercise in adults with type 2 diabetes. The FDA plans to continue to further investigate these safety issues to determine if changes in the prescribing information for this class of drugs is required.
"Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber," the FDA stated.
The FDA is also urging healthcare professionals to screen for the presence of acidosis, including ketoacidosis, in patients with signs of the condition. If these blood acids are detected, physicians should inform the patients to immediately stop using the drugs and take action to correct the acidosis and keep blood sugar levels in check.
The FDA warned that when untreated, type 2 diabetes can have serious side effects including "blindness, nerve and kidney damage, and heart disease." SGLT2 inhibitors lower blood sugar by prompting the kidneys to remove blood sugar through the urine.
