{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T07:55:51Z","timestamp":1767167751523,"version":"build-2238731810"},"reference-count":43,"publisher":"BMJ","license":[{"start":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T00:00:00Z","timestamp":1588118400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.bmj.com\/company\/legal-information\/terms-conditions\/legal-information\/tdm-licencepolicy"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"DOI":"10.1136\/bmj.m1107","type":"journal-article","created":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T23:55:27Z","timestamp":1588204527000},"page":"m1107","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Communicating emerging risks of SGLT2 inhibitors\u2014timeliness and transparency of medicine regulators"],"prefix":"10.1136","author":[{"given":"Alice","family":"Bhasale","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Mintzes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ameet","family":"Sarpatwari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,4,29]]},"reference":[{"key":"2020050409150686000_369.apr29_9.m1107.1","unstructured":"US Institute of Medicine . Committee on the Assessment of the US Drug Safety System. The future of drug safety\u2014promoting and protecting the health of the public. In: Baciu A Stratton K Burke SP , eds. Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice. The National Academies Press, 2006."},{"key":"2020050409150686000_369.apr29_9.m1107.2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c1848"},{"key":"2020050409150686000_369.apr29_9.m1107.3","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1617"},{"key":"2020050409150686000_369.apr29_9.m1107.4","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629010-00007"},{"key":"2020050409150686000_369.apr29_9.m1107.5","unstructured":"European Medicines Agency. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim. 2010. https:\/\/www.ema.europa.eu\/en\/news\/european-medicines-agency-recommends-suspension-avandia-avandamet-avaglim."},{"key":"2020050409150686000_369.apr29_9.m1107.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1010788"},{"key":"2020050409150686000_369.apr29_9.m1107.7","unstructured":"US Department of Health and Human Services Food and Drug Administration. Guidance for industry. Diabetes mellitus\u2014evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008. https:\/\/www.federalregister.gov\/documents\/2008\/12\/19\/E8-30086\/guidance-for-industry-on-diabetes-mellitus-evaluating-cardiovascular-risk-in-new-antidiabetic"},{"key":"2020050409150686000_369.apr29_9.m1107.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"2020050409150686000_369.apr29_9.m1107.9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504720"},{"key":"2020050409150686000_369.apr29_9.m1107.10","unstructured":"Health Canada. Summary Basis of Decision. Invokana. Health Canada Ottawa: Health Canada, 2014. https:\/\/hpr-rps.hres.ca\/reg-content\/summary-basis-decision-detailTwo.php?linkID=SBD00255#Brandname4 ."},{"key":"2020050409150686000_369.apr29_9.m1107.11","unstructured":"US Department of Health and Human Services Food and Drug Administration. Canagliflozin Summary Review. 204042Orig1s000. 2013. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/204042orig1s000sumr.pdf"},{"key":"2020050409150686000_369.apr29_9.m1107.12","unstructured":"US Department of Health and Human Services Food and Drug Administration . Application Number: 204042orig1s000 Medical Review(s). FDA, 2013."},{"key":"2020050409150686000_369.apr29_9.m1107.13","unstructured":"Australian Government Department of Health Therapeutic Goods Administration . Australian Public Assessment Report for Canagliflozin (as hemihydrate). TGA, 2014."},{"key":"2020050409150686000_369.apr29_9.m1107.14","unstructured":"European Medicines Agency. Assessment report. Canagliflozin. EMA\/374133\/2013 Committee for Medicinal Products for Human Use (CHMP) ed. London: EMA, 2013."},{"key":"2020050409150686000_369.apr29_9.m1107.15","unstructured":"European Medicines Agency . Pharmacovigilance Risk Assessment Committee (PRAC). Minutes of the PRAC meeting on 11-14 April 2016. EMA, 2016."},{"key":"2020050409150686000_369.apr29_9.m1107.16","unstructured":"European Medicines Agency . PRAC assessment report. Procedure under Article 20 of Regulation (EC) No 726\/2004 resulting from pharmacovigilance data. SGLT2 inhibitors and lower limb amputation (canagliflozin, dapagliflozin, empagliflozin-containing medicines). EMA\/PRAC\/637349\/2016. EMA, 2017."},{"key":"2020050409150686000_369.apr29_9.m1107.17","unstructured":"US Department of Health and Human Services Food and Drug Administration. FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. 18 May 2016. 2016. https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm500965.htm."},{"key":"2020050409150686000_369.apr29_9.m1107.18","unstructured":"Napp Pharmaceuticals. Invokana. Summary of product characteristics. Updated 13 Sep 2018. UK."},{"key":"2020050409150686000_369.apr29_9.m1107.19","unstructured":"US Food and Drug Administration Center for Drug Evaluation and Research. Approval Package for: Application Number: 204042Orig1s026 Trade Name: INVOKANA Generic Name: Canagliflozin. 2017. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2017\/204042Orig1s026.pdf."},{"key":"2020050409150686000_369.apr29_9.m1107.20","unstructured":"US Department of Health and Human Services Food and Drug Administration. FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density. 09 October 2015. 2015. https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm461449.htm."},{"key":"2020050409150686000_369.apr29_9.m1107.21","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-1860"},{"key":"2020050409150686000_369.apr29_9.m1107.22","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-3167"},{"key":"2020050409150686000_369.apr29_9.m1107.23","doi-asserted-by":"publisher","DOI":"10.1111\/1468-0009.12413"},{"key":"2020050409150686000_369.apr29_9.m1107.24","unstructured":"United States Government Accountability Office . Drug safety. FDA expedites many applications, but data for postapproval oversight need improvement. GAO, 2015."},{"key":"2020050409150686000_369.apr29_9.m1107.25","doi-asserted-by":"publisher","DOI":"10.1038\/nrd.2017.135"},{"key":"2020050409150686000_369.apr29_9.m1107.26","unstructured":"OECD Data . Population Paris: OECD. 2019 https:\/\/data.oecd.org\/pop\/population.htm."},{"key":"2020050409150686000_369.apr29_9.m1107.27","unstructured":"European Medicines Agency . Connecting the dots. Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives. EMA, 2016."},{"key":"2020050409150686000_369.apr29_9.m1107.28","unstructured":"Health Canada . Health product vigilance framework. Health Canada, 2012."},{"key":"2020050409150686000_369.apr29_9.m1107.29","unstructured":"European Medicines Agency . Guideline on good pharmacovigilance practices (GVP). Module IX Signal management (Rev 1). EMA with HMA, 2017."},{"key":"2020050409150686000_369.apr29_9.m1107.30","unstructured":"European Medicines Agency . Questions & answers on Article 31 pharmacovigilance referral procedures. EMA, 2015."},{"key":"2020050409150686000_369.apr29_9.m1107.31","unstructured":"European Medicines Agency . Assessment report. Dapagliflozin. EMA\/689976\/2012. EMA, 2012."},{"key":"2020050409150686000_369.apr29_9.m1107.32","first-page":"302","article-title":"European pharmacovigilance: increasingly outsourced to drug companies","volume":"23","author":"Anonymous","year":"2014","journal-title":"Prescrire Int"},{"key":"2020050409150686000_369.apr29_9.m1107.33","unstructured":"Lexchin J . Public profits vs private policy. University of Toronto Press, 2016."},{"key":"2020050409150686000_369.apr29_9.m1107.34","unstructured":"Health Canada and the Public Health Agency of Canada. Evaluation of the Human Drugs Program 1999-2000 to 2011-2012. 2014."},{"key":"2020050409150686000_369.apr29_9.m1107.35","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-017-0535-0"},{"key":"2020050409150686000_369.apr29_9.m1107.36","doi-asserted-by":"publisher","DOI":"10.1007\/BF03261992"},{"key":"2020050409150686000_369.apr29_9.m1107.37","doi-asserted-by":"publisher","DOI":"10.1038\/nrd2664"},{"key":"2020050409150686000_369.apr29_9.m1107.38","doi-asserted-by":"publisher","DOI":"10.1136\/bmjqs-2012-001704"},{"key":"2020050409150686000_369.apr29_9.m1107.39","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0109100"},{"key":"2020050409150686000_369.apr29_9.m1107.40","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0259-3"},{"key":"2020050409150686000_369.apr29_9.m1107.41","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.0266"},{"key":"2020050409150686000_369.apr29_9.m1107.42","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.0294"},{"key":"2020050409150686000_369.apr29_9.m1107.43","doi-asserted-by":"publisher","DOI":"10.1177\/1073110517750615"}],"updated-by":[{"DOI":"10.1136\/bmj.m1745","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2020,5,4]],"date-time":"2020-05-04T00:00:00Z","timestamp":1588550400000}}],"container-title":["BMJ"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/data.bmj.org\/tdm\/10.1136\/bmj.m1107","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmj.m1107","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T23:57:42Z","timestamp":1601078262000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.m1107"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,29]]},"references-count":43,"alternative-id":["10.1136\/bmj.m1107"],"URL":"https:\/\/doi.org\/10.1136\/bmj.m1107","relation":{},"ISSN":["1756-1833"],"issn-type":[{"value":"1756-1833","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4,29]]}}}