FDA Warns of Serious Blood Problems Linked to Six Diabetes Drugs

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a class of prescription medicines that the Food and Drug Administration (FDA) approved to lower blood sugar in adults with type 2 diabetes. Obesity is a leading cause of type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems such as blindness, heart disease, nerve, and kidney damage. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through urine.

The FDA warned that SGLT2 inhibitors may lead to ketoacidosis, a serious, potentially fatal condition in which the body overproduces a chemical called ketone and results in too much acid in the blood. The warning includes the following SGLT2 inhibitors:

• Canagliflozin (Invokana, Johnson & Johnson)
• Dapagliflozin (Farxiga, AstraZeneca)
• Empagliflozin (Jardiance, Lilly/Boehringer)

As well as three combination products which include an SGLT2 inhibitor:

• Canagliflozin plus metformin (Invokamet, Johnson & Johnson)
• Dapagliflozin plus metformin extended release (Xigduo XR, AstraZeneca)
• Empagliflozin plus linagliptin (Glyxambi, Lilly/Boehringer)

Interesting fact: if your urine attracts ants, you may have diabetes. Photo by L. Shyamal.

Between March 2013 and June 2014, the FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 which all the affected patients required emergency room visits or hospitalization to treat the condition.

Signs of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue and sleepiness. “Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels,” the FDA stated.

Patients should pay attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as the following:

• Abdominal pain
• Confusion
• Difficulty breathing
• Nausea
• Unusual fatigue or sleepiness
• Vomiting

It is important for patients to talk to their prescriber before stopping and/or changing their diabetes medicines. Doctors are urged to evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms. Doctors are also recommended to discontinue SGLT2 inhibitors if acidosis is confirmed and to take appropriate measures to correct the acidosis and monitor sugar levels.

The FDA has asked healthcare professionals to report adverse effects involving SGLT2 inhibitors to MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.