近日，美国食品与药物管理局(FDA)发布通告称，用于治疗2型糖尿病的钠-葡萄糖协同转运蛋白2(SGLT-2)抑制剂可增加酮症酸中毒和严重尿路感染风险。
        FDA相关部门表示，既往已报道了分别有73例和19例服用SGLT-2抑制剂的患者发生了糖尿病酮症酸中毒以及尿脓毒症和肾盂肾炎。所有患者均需住院或急诊门诊治疗。
        FDA建议，服用SGLT-2抑制剂患者如果出现相关症状(腹痛、呕吐等)，临床医生应评估是否发生了酮症酸中毒。需注意的是，即使患者血糖水平不那么十分高的情况下也有可能发生酮症酸中毒。一旦怀疑患者发生了酮症酸中毒，应停用SGLT-2抑制剂并立即治疗相应的并发症。同样，还应即刻治疗尿路感染。
        SGLT-2抑制剂包括坎格列净(canagliflozin)、达格列净(dapagliflozin)和依帕列净(empagliflozin)，FDA已要求上述药物的相应厂商进行上市后安全研究。
FDA通告原文

SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
[Posted 12/04/2015]
AUDIENCE: Pharmacy, Emergency Medicine
ISSUE: An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.
FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that the Agency would continue to evaluate this safety issue. A review of the FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors (see the Drug Safety Communication Data Summary). Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.
As a result, FDA added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations. FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years. BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin.
RECOMMENDATION: Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.
Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms.  Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high. If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly.