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    377156
    Peer Reviewed

    The impact of the boxed warning on the duration of use for depot medroxprogesterone acetate.

    Eworuke E; Lee JY; Soule L; Popat V; Moeny DG

    Pharmacoepidemiology and Drug Safety. 2017 Jul; 26(7):827-836.

    OBJECTIVE: 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). METHODS: From the IMS Lifelink data (2001-2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90-day DMPA or 30-day CHC between claims. Days' supply (CHC) and 90-day 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 years before and after the Food and Drug Administration's November 2004 boxed warning. Stratified analyses by birth cohort were conducted. RESULTS: From 2001 to 2009, 126 528 DMPA and 651 356 CHC episodes were used for segmented regression. For the DMPA cohort, there was an immediate decline in the mean duration (-34.7 days [confidence interval: -45.4 to -24.1]) and episodes >2 years (-1.9% [confidence interval: -2.9% to -1.1%]) after the boxed warning. We did not observe any change in mean duration or episodes >2 years for the CHC cohort. The largest declines in mean duration and proportion >2 years were seen with the oldest women. CONCLUSION: We observed a modest decline in the mean duration and episodes >2 years 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 years in all age groups, except adolescents who continue to use DMPA for longer than 2 years. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
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