OBJECTIVE In 2016, the U.S. Food and Drug Administration (FDA) revised metformin's label to permit use in patients with mild-moderate chronic kidney disease. We sought to determine whether this change was associated with increased reports of metformin-associated lactic acidosis (MALA) to the FDA's Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS Publicly available FAERS reports were analyzed. RESULTS MALA reports increased from 521 in 2015 to 1,939 in 2018. After restriction to U.S. reports, absolute and relative increase in MALA reports was less, from 111 to 243. The proportionate reporting ratio (PRR), a measure adjusted for rates of other adverse event reports, was stable. CONCLUSIONS The increased reports deserve attention, but the PRR's stability and FAERS's known limitations, including lack of a denominator or control group, do not permit the conclusion that U.S. MALA rates have increased. Further study with more robust data sources is needed.

中文翻译：

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2015-2018年归因于二甲双胍的乳酸性酸中毒报告。

目标2016年，美国食品药品监督管理局（FDA）修改了二甲双胍的标签，以允许用于轻度中度慢性肾脏病患者。我们试图确定这种变化是否与向FDA不良事件报告系统（FAERS）报告的二甲双胍相关的乳酸性酸中毒（MALA）增多有关。研究设计和方法分析了公开提供的FAERS报告。结果MALA报告从2015年的521个增加到2018年的1,939个。在限制了美国报告之后，MALA报告的绝对和相对增加较少，从111个增加到243个。按比例报告比率（PRR），该比率已针对其他不良事件的发生率进行了调整事件报告，很稳定。结论增加的报告值得关注，但是PRR的稳定性和FAERS的已知局限性，包括缺乏分母或对照组，不能得出美国MALA利率上升的结论。需要使用更可靠的数据源进行进一步研究。