Reports of Lactic Acidosis Attributed to Metformin, 2015–2018

James H. Flory, Sean Hennessy, Clifford J. Bailey, Silvio E. Inzucchi

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)244-246
Number of pages3
JournalDiabetes Care
Volume43
Issue number1
Early online date9 Oct 2019
DOIs
Publication statusPublished - 1 Jan 2020

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Lactic Acidosis
Metformin
Information Storage and Retrieval
United States Food and Drug Administration
Chronic Renal Insufficiency
Research Design
Control Groups

Bibliographical note

© 2019 by the American Diabetes Association. http://www.diabetesjournals.org/content/license
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

Cite this

Flory, James H. ; Hennessy, Sean ; Bailey, Clifford J. ; Inzucchi, Silvio E. / Reports of Lactic Acidosis Attributed to Metformin, 2015–2018. In: Diabetes Care. 2020 ; Vol. 43, No. 1. pp. 244-246.
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Reports of Lactic Acidosis Attributed to Metformin, 2015–2018. / Flory, James H.; Hennessy, Sean; Bailey, Clifford J.; Inzucchi, Silvio E.

In: Diabetes Care, Vol. 43, No. 1, 01.01.2020, p. 244-246.

Research output: Contribution to journalArticle

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