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

ObjectiveThe 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). MethodsFrom the IMS Lifelink data (2001-2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6months 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 >2years before and after the Food and Drug Administration's November 2004 boxed warning. Stratified analyses by birth cohort were conducted. ResultsFrom 2001 to 2009, 126528 DMPA and 651356 CHC episodes were used for segmented regression. For the DMPA cohort, there was an immediate decline in the mean duration (-34.7days [confidence interval: -45.4 to -24.1]) and episodes >2years (-1.9% [confidence interval: -2.9% to -1.1%]) after the boxed warning. We did not observe any change in mean duration or episodes >2years for the CHC cohort. The largest declines in mean duration and proportion >2years were seen with the oldest women. ConclusionWe observed a modest decline in the mean duration and episodes >2years 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 >2years in all age groups, except adolescents who continue to use DMPA for longer than 2years. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.