SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
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.
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℉ 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
Health care professionals should:
• 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.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm
Sodium-glucose cotransporter 2 (SGLT2)抑制劑為糖尿病用藥，美國FDA核准用於合併飲食和運動，以降低成人第二型糖尿病的血糖值。其作用機轉為減少腎臟對血糖之再吸收，增加血糖由尿液排出。2013年美國FDA核准第一個SGLT2抑制劑，至今上市的同類藥品包含canagliflozin、dapagliflozin、empagliflozin和ertugliflozin。此外，empagliflozin亦被美國FDA核准用於降低第二型糖尿病及心臟病患者其心臟病發作和中風死亡的風險。未經治療的第二型糖尿病可能導致嚴重併發症，包括失明、神經和腎臟損害及心臟疾病。
美國FDA發布藥物安全警訊，有接獲使用SGLT2抑制劑後出現罕見但嚴重的生殖器及生殖器周圍感染的案例通報。此嚴重且罕見之皮膚組織細菌感染，稱為會陰部位的壞死性筋膜炎，亦稱為Fournier's gangrene。美國FDA要求將此新警語加入所有SGLT2抑制劑的仿單以及病人用藥指南中。
病人應注意事項：
1. 如果出現任何生殖器或其周邊區域的壓痛、紅、腫，且發燒超過38℃或感覺不適，請立即就醫，因為這些症狀可能會迅速惡化。
2. 每次醫師為您開立SGLT2抑制劑時，請再次閱讀病人用藥指南，以確認是否有此藥品相關之新訊息或警語及此藥品益處和風險之相關資訊。
醫療專業人員應注意事項：
1.若病人出現上述症狀，請評估Fournier's gangrene之可能性。
2.一旦懷疑是Fournier's gangrene，如有需要，請立即使用廣效性抗生素和外科清創手術治療，並停用SGLT2抑制劑，密切監測血糖值，以提供適當的替代療法控制血糖。
相關訊息與其他完整的建議請參考FDA網址：https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm
[Posted 08/29/2018]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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