{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:15:19Z","timestamp":1790716519951,"version":"4.1.0"},"reference-count":12,"publisher":"American Diabetes Association","issue":"1","license":[{"start":{"date-parts":[[2019,12,20]],"date-time":"2019-12-20T00:00:00Z","timestamp":1576800000000},"content-version":"vor","delay-in-days":72,"URL":"http:\/\/www.diabetesjournals.org\/content\/license"}],"funder":[{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","award":["K08-HS-023898"],"award-info":[{"award-number":["K08-HS-023898"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006093","name":"Patient-Centered Outcomes Research Institute","doi-asserted-by":"publisher","award":["CER-2017C3-9230"],"award-info":[{"award-number":["CER-2017C3-9230"]}],"id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,1,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>In 2016, the U.S. Food and Drug Administration (FDA) revised metformin\u2019s 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\u2019s Adverse Event Reporting System (FAERS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>Publicly available FAERS reports were analyzed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>The increased reports deserve attention, but the PRR\u2019s stability and FAERS\u2019s 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc19-0923","type":"journal-article","created":{"date-parts":[[2019,10,10]],"date-time":"2019-10-10T01:14:16Z","timestamp":1570670056000},"page":"244-246","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":25,"title":["Reports of Lactic Acidosis Attributed to Metformin, 2015\u20132018"],"prefix":"10.2337","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0259-969X","authenticated-orcid":false,"given":"James H.","family":"Flory","sequence":"first","affiliation":[{"name":"Memorial Sloan-Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Hennessy","sequence":"additional","affiliation":[{"name":"University of Pennsylvania Perelman School of Medicine, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6998-6811","authenticated-orcid":false,"given":"Clifford J.","family":"Bailey","sequence":"additional","affiliation":[{"name":"School of Life and Health Sciences, Aston University, Birmingham, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1254-6636","authenticated-orcid":false,"given":"Silvio E.","family":"Inzucchi","sequence":"additional","affiliation":[{"name":"Yale School of Medicine, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2019,10,9]]},"reference":[{"key":"2022031223563498100_B1","doi-asserted-by":"crossref","first-page":"1405","DOI":"10.1161\/CIRCULATIONAHA.116.023041","article-title":"Citizen petition to the US Food and Drug Administration to change prescribing guidelines: the metformin experience","volume":"134","author":"Lipska","year":"2016","journal-title":"Circulation"},{"key":"2022031223563498100_B2","doi-asserted-by":"crossref","first-page":"2668","DOI":"10.1001\/jama.2014.15298","article-title":"Metformin in patients with type 2 diabetes and kidney disease: a systematic review","volume":"312","author":"Inzucchi","year":"2014","journal-title":"JAMA"},{"key":"2022031223563498100_B3","first-page":"CD002967","article-title":"Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus","volume":"4","author":"Salpeter","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"2022031223563498100_B4","unstructured":"U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard [Internet]. Available from https:\/\/www.fda.gov\/drugs\/fda-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard. Accessed 14 July 2019"},{"key":"2022031223563498100_B5","unstructured":"U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files [Internet]. Available from https:\/\/fis.fda.gov\/extensions\/FPD-QDE-FAERS\/FPD-QDE-FAERS.html. Accessed 14 July 2019"},{"key":"2022031223563498100_B6","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1002\/pds.677","article-title":"Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2022031223563498100_B7","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1186\/s12882-018-0875-8","article-title":"Metformin associated lactic acidosis: a case series of 28 patients treated with sustained low-efficiency dialysis (SLED) and long-term follow-up","volume":"19","author":"Angioi","year":"2018","journal-title":"BMC Nephrol"},{"key":"2022031223563498100_B8","unstructured":"European Medicines Agency. Change management for the launch of the new EudraVigilance system [Internet]. Available from https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/pharmacovigilance\/eudravigilance\/change-management-launch-new-eudravigilance-system. Accessed 5 May 2019"},{"key":"2022031223563498100_B9","doi-asserted-by":"crossref","first-page":"1199","DOI":"10.1111\/dom.13642","article-title":"Metformin use and cardiovascular events in patients with type 2 diabetes and chronic kidney disease","volume":"21","author":"Charytan","year":"2019","journal-title":"Diabetes Obes Metab"},{"key":"2022031223563498100_B10","doi-asserted-by":"crossref","first-page":"903","DOI":"10.1001\/jamainternmed.2018.0292","article-title":"Association of metformin use with risk of lactic acidosis across the range of kidney function: a community-based cohort study","volume":"178","author":"Lazarus","year":"2018","journal-title":"JAMA Intern Med"},{"key":"2022031223563498100_B11","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1007\/s11606-017-4219-3","article-title":"Mortality associated with metformin versus sulfonylurea initiation: a cohort study of veterans with diabetes and chronic kidney disease","volume":"33","author":"Marcum","year":"2018","journal-title":"J Gen Intern Med"},{"key":"2022031223563498100_B12","doi-asserted-by":"crossref","first-page":"547","DOI":"10.2337\/dc17-2231","article-title":"Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4","volume":"41","author":"Lalau","year":"2018","journal-title":"Diabetes Care"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/care.diabetesjournals.org\/syndication\/doi\/10.2337\/dc19-0923","content-type":"unspecified","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/43\/1\/244\/529913\/dc190923.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/43\/1\/244\/529913\/dc190923.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,13]],"date-time":"2022-03-13T03:54:54Z","timestamp":1647143694000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/43\/1\/244\/35932\/Reports-of-Lactic-Acidosis-Attributed-to-Metformin"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,9]]},"references-count":12,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2019,10,9]]},"published-print":{"date-parts":[[2020,1,1]]}},"URL":"https:\/\/doi.org\/10.2337\/dc19-0923","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,9]]}}}