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(em'' pa gli floe' zin)[Posted 08/29/2018] AUDIENCE: Patient, Endocrinology, Health Professional, Pharmacy ISSUE: FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier's gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. BACKGROUND: SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. RECOMMENDATION: To read all of the recommendations see the Drug Safety Communication, available at: http://bit.ly/2wNOpdK. Patients should:
- Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
- Read the patient Medication Guide every time you receive a prescription for an SGLT2 inhibitor because there may be new or important additional information about your drug. The Medication Guide explains the benefits and risks associated with the medicine
- Assess patients for Fournier's gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary.
- Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Before taking empagliflozin,
- tell your doctor and pharmacist if you are allergic to empagliflozin, any other medications, or any of the ingredients in empagliflozin tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: diuretics ('water pills'); or insulin or oral medications for diabetes such as chlorpropamide (Diabinese), glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase, in Glucovance), tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you are on dialysis and if you have or have ever had kidney disease. Your doctor may tell you not to take empagliflozin.
- tell your doctor if you have or have ever had urinary tract infections or problems with urination, low blood pressure, if you are on a low sodium diet, if you have yeast infections in the genital area, or liver disease. If you are male, tell your doctor if you have never been circumcised.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking empagliflozin. If you become pregnant while taking empagliflozin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking empagliflozin.
- you should know that empagliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. If you have this problem, call your doctor. This problem is more common when you first start taking empagliflozin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up
- ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of empagliflozin you may need.
- urinating a lot, including at night
- increased thirst
- frequent, urgent, burning, or painful urination
- urine that is cloudy
- pelvic or back pain
- (in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
- (in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
- flu-like symptoms
- dry mouth, nausea and vomiting, stomach pain, unusual fatigue or tiredness, difficulty breathing, breath that smells fruity, decreased consciousness or confusion