{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,2]],"date-time":"2025-05-02T00:30:21Z","timestamp":1746145821745,"version":"3.37.3"},"reference-count":19,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2017,5,23]],"date-time":"2017-05-23T00:00:00Z","timestamp":1495497600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,7]]},"abstract":"Abstract<\/jats:title>Objective<\/jats:title>The objective of this study was to examine the impact of the Food and Drug Administration's boxed warning on the utilization of depot medroxyprogesterone (DMPA).<\/jats:p><\/jats:sec>Methods<\/jats:title>From the IMS Lifelink data (2001\u20132009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6\u00a0months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90\u2010day DMPA or 30\u2010day CHC between claims. Days' supply (CHC) and 90\u2010day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode length and proportion of episodes >2\u00a0years before and after the Food and Drug Administration's November 2004 boxed warning. Stratified analyses by birth cohort were conducted.<\/jats:p><\/jats:sec>Results<\/jats:title>From 2001 to 2009, 126\u00a0528 DMPA and 651\u00a0356 CHC episodes were used for segmented regression. For the DMPA cohort, there was an immediate decline in the mean duration (\u221234.7\u00a0days [confidence interval: \u221245.4 to \u221224.1]) and episodes >2\u00a0years (\u22121.9% [confidence interval: \u22122.9% to \u22121.1%]) after the boxed warning. We did not observe any change in mean duration or episodes >2\u00a0years for the CHC cohort. The largest declines in mean duration and proportion >2\u00a0years were seen with the oldest women.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>We observed a modest decline in the mean duration and episodes >2\u00a0years for DMPA use immediately after the boxed warning not observed among CHC users. In the stratified analysis, we saw declines in the duration of use >2\u00a0years in all age groups, except adolescents who continue to use DMPA for longer than 2\u00a0years. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4227","type":"journal-article","created":{"date-parts":[[2017,5,25]],"date-time":"2017-05-25T15:58:29Z","timestamp":1495727909000},"page":"827-836","source":"Crossref","is-referenced-by-count":4,"title":["The impact of the boxed warning on the duration of use for depot medroxprogesterone acetate"],"prefix":"10.1002","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8971-9748","authenticated-orcid":false,"given":"Efe","family":"Eworuke","sequence":"first","affiliation":[{"name":"Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joo\u2010Yeon","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Biometrics VII, Office of Biostatistics Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Soule","sequence":"additional","affiliation":[{"name":"Division of Bone, Reproductive, and Urologic Products Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vaishali","family":"Popat","sequence":"additional","affiliation":[{"name":"Office of New Drugs, Immediate Office Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David G.","family":"Moeny","sequence":"additional","affiliation":[{"name":"Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,5,23]]},"reference":[{"volume-title":"Depo\u2010Provera (NDA 020246) Label and Approval History","author":"Services USHaH","key":"e_1_2_10_2_1"},{"volume-title":"Depo\u2010Sub Q Provera (NDA 021583) Label and Approval History","author":"Services USHaH","key":"e_1_2_10_3_1"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(01)01748-4"},{"issue":"5","key":"e_1_2_10_5_1","doi-asserted-by":"crossref","first-page":"899","DOI":"10.1097\/01.AOG.0000117082.49490.d5","article-title":"Effects of hormonal contraception on bone mineral density after 24 months of use","volume":"103","author":"Berenson AB","journal-title":"Obstet Gynecol"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/00006250-200110000-00009"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1054-139X(02)00567-0"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2004.04.064"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpag.2003.11.017"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/00006250-200005000-00021"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.159.2.139"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2003.10.005"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1479-828X.1997.tb02260.x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2006.03.010"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2009.11.003"},{"key":"e_1_2_10_16_1","unstructured":"World Health Organization.Technical consultation on the effects of hormonal contraception on bone health.2007. 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