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Reports of Lactic Acidosis Attributed to Metformin, 2015-2018.
- Source :
-
Diabetes care [Diabetes Care] 2020 Jan; Vol. 43 (1), pp. 244-246. Date of Electronic Publication: 2019 Oct 09. - Publication Year :
- 2020
-
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).<br />Research Design and Methods: Publicly available FAERS reports were analyzed.<br />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.<br />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.<br /> (© 2019 by the American Diabetes Association.)
- Subjects :
- Adult
Adverse Drug Reaction Reporting Systems history
Adverse Drug Reaction Reporting Systems statistics & numerical data
Adverse Drug Reaction Reporting Systems trends
Aged
Diabetic Nephropathies drug therapy
Diabetic Nephropathies epidemiology
Female
History, 21st Century
Humans
Hypoglycemic Agents adverse effects
Male
Middle Aged
Renal Insufficiency, Chronic complications
Renal Insufficiency, Chronic drug therapy
Renal Insufficiency, Chronic epidemiology
United States epidemiology
United States Food and Drug Administration
Young Adult
Acidosis, Lactic chemically induced
Acidosis, Lactic epidemiology
Metformin adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1935-5548
- Volume :
- 43
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Diabetes care
- Publication Type :
- Academic Journal
- Accession number :
- 31597667
- Full Text :
- https://doi.org/10.2337/dc19-0923