Reports of Lactic Acidosis Attributed to Metformin, 2015–2018

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

doi:10.2337/dc19-0923

Reports of Lactic Acidosis Attributed to Metformin, 2015–2018

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

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	244-246
Number of pages	3
Journal	Diabetes Care
Volume	43
Issue number	1
Early online date	9 Oct 2019
DOIs	https://doi.org/10.2337/dc19-0923
Publication status	Published - 1 Jan 2020

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.

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10.2337/dc19-0923

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title = "Reports of Lactic Acidosis Attributed to Metformin, 2015–2018",

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.",

author = "Flory, {James H.} and Sean Hennessy and Bailey, {Clifford J.} and Inzucchi, {Silvio E.}",

note = "{\textcopyright} 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.",

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doi = "10.2337/dc19-0923",

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AU - Flory, James H.

AU - Hennessy, Sean

AU - Bailey, Clifford J.

AU - Inzucchi, Silvio E.

N1 - © 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.

PY - 2020/1/1

Y1 - 2020/1/1

N2 - 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.

AB - 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.

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Reports of Lactic Acidosis Attributed to Metformin, 2015–2018

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Response to Comment on Flory et al. Reports of Lactic Acidosis Attributed to Metformin, 2015–2018. Diabetes Care 2020;43:244–246

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