{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T22:51:26Z","timestamp":1761519086720},"reference-count":35,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,12,2]],"date-time":"2013-12-02T00:00:00Z","timestamp":1385942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Obesity"],"published-print":{"date-parts":[[2014,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the impact of FDA safety communications regarding the weight loss medications sibutramine and orlistat.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The 2008 to 2011 pharmacy claims data from CVS Caremark were used to determine the effect of the relevant FDA warnings on (1) use of sibutramine and orlistat, (2) their rates of discontinuation, and (3) substitution to an alternate weight loss medication in the 3\u2010month period following discontinuation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The use of sibutramine, orlistat, or phentermine declined from 45 users per 100,000 Caremark enrollees in May 2008 to 24 users per 100,000 enrollees in December 2010. In the time series analyses of overall use of medications, a very small decline in the trend of use of sibutramine after the FDA communication (0.000002% per month decline after the communication; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001) was found. However, rates of discontinuation of sibutramine and orlistat were similar before and after relevant FDA communications (all <jats:italic>P<\/jats:italic> values &gt;0.1 for both level and trend changes post\u2010warning). Patients discontinuing sibutramine post\u2010communication increased use of phentermine at a rate of 0.004% per month after discontinuation (<jats:italic>P<\/jats:italic>\u2009=\u20090.01).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>From 2008 to 2010, use of prescription weight loss medications was low and declined over time. FDA communications regarding the safety of these medications had limited effect on use.<\/jats:p><\/jats:sec>","DOI":"10.1002\/oby.20596","type":"journal-article","created":{"date-parts":[[2013,8,8]],"date-time":"2013-08-08T15:25:28Z","timestamp":1375975528000},"page":"943-949","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Time series analyses of the effect of FDA communications on use of prescription weight loss medications"],"prefix":"10.1002","volume":"22","author":[{"given":"Jason P.","family":"Block","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Medical School\/Harvard Pilgrim Health Care Institute Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niteesh K.","family":"Choudhry","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel P.","family":"Carpenter","sequence":"additional","affiliation":[{"name":"Department of Government Harvard University Cambridge Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael A.","family":"Fischer","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Troyen A.","family":"Brennan","sequence":"additional","affiliation":[{"name":"CVS Caremark Northbrook Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela Y.","family":"Tong","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olga S.","family":"Matlin","sequence":"additional","affiliation":[{"name":"CVS Caremark Northbrook Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William H.","family":"Shrank","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA"},{"name":"Center for Medicare and Medicaid Innovation, Center for Medicare and Medicaid Services, US Department of Health and Human Services Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,12,2]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-143-5-200509060-00013"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMe058243"},{"key":"e_1_2_5_4_1","unstructured":"FDA announces withdrawal Fenfluramine and Dexfenfluramine (Fen\u2010Phen). 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