Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004-2015

Megumi Horibe, Yuuki Hane, Junko Abe, Toshinobu Matsui, Yamato Kato, Natsumi Ueda, Sayaka Sasaoka, Yumi Motooka, Haruna Hatahira, Shiori Hasegawa, Yasutomi Kinosada, Hideaki Hara, Mitsuhiro Nakamura, Megumi Horibe, Yuuki Hane, Junko Abe, Toshinobu Matsui, Yamato Kato, Natsumi Ueda, Sayaka Sasaoka, Yumi Motooka, Haruna Hatahira, Shiori Hasegawa, Yasutomi Kinosada, Hideaki Hara, Mitsuhiro Nakamura

Abstract

Aim: Postpartum depression is a mood disorder that commonly affects women during the early postpartum period. The objective of this study was to analyse the association of postpartum depression with drugs (including contraceptive devices and implants) with spontaneously reported adverse events reported in the US Food and Drug Administration Adverse Event Reporting System database.

Design: Retrospective study.

Method: Reports of postpartum depression events between 2004-2015 were analysed with a reporting odds ratio (ROR) algorithm. The Medical Dictionary for Regulatory Activities was used to identify postpartum depression.

Results: The reporting odds ratios (95% confidence intervals, CI) of levonorgestrel (an intrauterine device with progestogen), etonogestrel (a hormonal contraceptive implant), sertraline and drospirenone (an oral contraceptive) were 12.5 (8.7-18.0), 14.0 (8.5-22.8), 12.2 (6.5-23.1) and 5.4 (2.7-10.9) respectively. Among the drugs in the US Food and Drug Administration Adverse Event Reporting System database, the use of contraceptives or an intrauterine device with progestogen might convey risk for postpartum depression.

Keywords: FAERS; adverse event reporting system; contraception; intrauterine device; nurses; nursing; postpartum depression.

Figures

Figure 1
Figure 1
Two‐by‐two contingency table for analysis

References

    1. Abe, J. , Umetsu, R. , Kato, Y. , Ueda, N. , Nakayama, Y. , Suzuki, Y. , … Nakamura, M. (2015). Evaluation of dabigatran‐ and warfarin‐associated hemorrhagic events using the FDA‐Adverse Event Reporting System database stratified by age. International Journal of Medical Sciences, 12, 312–321.
    1. American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders, Fifth Edition, (DSM‐5). Washington, DC: American Psychiatric Publishing;
    1. Bates, A. , & Evans, S. J. (2009). Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiology and Drug Safety, 18, 427–436.
    1. Beck, C. T. (2001). Predictors of postpartum depression: An update. Nursing Research, 50, 275–285.
    1. Carolan, M. (2005). “Doing it properly”: The experience of first mothering over 35 years. Health Care for Women International, 26, 764–787.
    1. Concato, J. , Shah, N. , & Horwitz, R. I. (2000). Randomized, controlled trials, observational studies and the hierarchy of research designs. The New England Journal of Medicine, 342, 1887–1892.
    1. Dennis, C. L. , & Creedy, D. (2004). Psychosocial and psychological interventions for preventing postpartum depression. The Cochrane Database of Systematic Reviews, 18, CD001134
    1. Duke, J. M. , Sibbritt, D. W. , & Young, A. F. (2007). Is there an association between the use of oral contraception and depressive symptoms in young Australian women? Contraception, 75, 27–31.
    1. Ernst, U. , Baumgartner, L. , Bauer, U. , & Janssen, G. (2002). Improvement of quality of life in women using a low‐dose desogestrel‐containing contraceptive: Results of an observational clinical evaluation. The European Journal of Contraception & Reproductive Health Care, 7, 238–243.
    1. FDA's Office of Women's Health . (2017). Medicine to Help You, Depression. Available from: . [last accessed 12 January 2017]
    1. Hardeman, J. , & Weiss, B. D. (2014). Intrauterine devices: An update. American Family Physician, 89, 445–450.
    1. Hipwell, A. E. , Goossens, F. A. , Melhuish, E. C. , & Kumar, R. (2000). Severe maternal psychopathology and infant‐mother attachment. Development and Psychopathology, 12, 157–175.
    1. International Council for Harmonisation . (1998). ICH E2B. Available from: . [last available 12 January 2017].
    1. International Council for Harmonisation . (2016). Introductory Guide MedDRA Version 19.0. Available from: . [last accessed 14 July 2016].
    1. Iwata, H. , Mori, E. , Tsuchiya, M. , Sakajo, A. , Saeki, A. , Maehara, K. , … Maekawa, T. (2015). Objective sleep of older primiparous. Japanese women during the first 4 months postpartum: An actigraphic study. International Journal of Nursing Practice, 21 (Suppl. 1), 2–9.
    1. Kennerley, H. , & Gath, D. (1989). Maternity blues. I. Detection and measurement by questionnaire. The British Journal of Psychiatry, 155, 356–362.
    1. Klainin, P. , & Arthur, D. G. (2009). Postpartum depression in Asian cultures: A literature review. International Journal of Nursing Studies, 46, 1355–1373.
    1. Luukkainen, T. , Pakarinen, P. , & Toivonen, J. (2001). Progestin‐releasing intrauterine systems. Seminars in Reproductive Medicine, 19, 355–363.
    1. Matsumoto, K. , Tsuchiya, K. , Itoh, H. , Kanayama, N. , Suda, S. , Matsuzaki, H. , … Takei, N. (2011). The HBC Study Team. Age‐specific 3‐month cumulative incidence of postpartum depression: The Hamamatsu Birth Cohort (HBC) study. Journal of Affective Disorders, 133, 607–610.
    1. Mehta, S. , & Mehta, N. (2014). An overview of risk factors associated to post‐partum depression in Asia. Mental Illness and the Death Penalty, 6, 5370
    1. O'Connell, K. , Davis, A. R. , & Kerns, J. (2007). Oral contraceptives: Side effects and depression in adolescent girls. Contraception, 75, 299–304.
    1. O'Hara, M. W. , & Swain, A. M. (1996). Rates and risk of postpartum depression‐a meta‐analysis. International Review of Psychiatry, 8, 37–54.
    1. Oinonen, K. A. , & Mazmanian, D. (2002). To what extent do oral contraceptives influence mood and affect? Journal of Affective Disorders, 70, 229–240.
    1. Pitt, B. (1973). Maternity blues. The British Journal of Psychiatry, 122, 431–433.
    1. Pluchino, N. , Cubeddu, A. , Giannini, A. , Merlini, S. , Cela, V. , Angioni, S. , & Genazzani, A. R. (2009). Progesterone and brain: An update. Maturitas, 62, 349–355.
    1. Poluzzi, E. , Raschi, E. , Piccinni, C. , & De Ponti, F. (2012). Data mining techniques in pharmacovigilance: Analysis of the publicly accessible FDA adverse event reporting system (AERS). INTECH, Chapter, 12, 265–302.
    1. Rapkin, A. J. , Morgan, M. , Sogliano, C. , Biggio, G. , & Concas, A. (2006). Decreased neuroactive steroids induced by combined oral contraceptive pills are not associated with mood changes. Fertility and Sterility, 85, 1371–1378.
    1. Sasaoka, S. , Matsui, T. , Hane, Y. , Abe, J. , Ueda, N. , Motooka, Y. , … Nakamura, M. (2016). Time‐to‐onset analysis of drug‐induced long QT syndrome based on a spontaneous reporting system for adverse drug events. PLoS ONE, 11, e0164309
    1. Stein, G. S. (1980). The pattern of mental change and body weight change in the first post‐partum week. Journal of Psychosomatic Research, 24, 165–171.
    1. Suzuki, Y. , Suzuki, H. , Umetsu, R. , Uranishi, H. , Abe, J. , Nishibata, Y. , … Nakamura, M. (2015). The analysis of the interaction between clopidogrel, aspirin and proton pump inhibitors using the FDA Adverse Event Reporting System database. Biological and Pharmaceutical Bulletin, 38, 680–686.
    1. Tamaki, A. (2008). Effectiveness of home visits by mental health nurses for Japanese women with post‐partum depression. International Journal of Mental Health Nursing, 17, 419–427.
    1. Tepper, N. K. , Phillips, S. J. , Kapp, N. , Gaffield, M. E. , & Curtis, K. M. (2015). Combined hormonal contraceptive use among breastfeeding women: An updated systematic review. Contraception, 94, 262–274.
    1. Toffol, E. , Heikinheimo, O. , Koponen, P. , Luoto, R. , & Partonen, T. (2011). Hormonal contraception and mental health: Results of a population‐based study. Human Reproduction, 26, 3085–3093.
    1. U. S. Food and Drug Administration . (2016). “ASC_NTS.DOC” File For The Quarterly Data Extract (QDE) from the fda adverse event reporting system (FAERS). Available from: . [last accessed 12 January 2017.]
    1. U. S. Food and Drug Administration . (2016). “README.DOC” File for the quarterly data extract (QDE) from thefda adverse event reporting system (FAERS). Available from: . [last accessed 12 January 2017.]
    1. U. S. Food and Drug Administration . (2008). Mirena (levonorgestrel‐releasing intrauterine system). Safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER). Available from: . [last accessed 12 January 2017.]
    1. Ueda, N. , Umetsu, R. , Abe, J. , Kato, Y. , Nakayama, Y. , Kato, Z. , Kinosada, Y. ,… Nakamura, M. (2015). Analysis of neuropsychiatric adverse events in patients treated with oseltamivir in spontaneous adverse event reports. Biological and Pharmaceutical Bulletin, 38, 1638–1644.
    1. Umetsu, R. , Abe, J. , Ueda, N. , Kato, Y. , Matsui, T. , Nakayama, Y. , … Nakamura, M. (2015). Association between selective serotonin reuptake inhibitor therapy and suicidality: Analysis of U.S. Food and Drug Administration adverse event reporting system data. Biological and Pharmaceutical Bulletin, 38, 1689–1699.
    1. van der Heijden, P. G. , van Puijenbroek, E. P. , van Buuren, S. , & van der Hofstede, J. W. (2002). On the assessment of adverse drug reactions from spontaneous reporting systems: The influence of under‐reporting on odds ratios. Statistics in Medicine, 21, 2027–2044.
    1. Wayne, N. J. (2013). Bayer HealthCare Pharmaceuticals, Skyla (levonorgestrel‐releasing intrauterine system) [package insert]. Available from: . [last accessed 12 January 2017.]
    1. World Health Organization . (2006). Report of a WHO technical consultation on birth spacing. Available from: . [last accessed 12 January 2017.]
    1. World Health Organization . (2008). Maternal mental health and child health and development in low and middle income countries. Available from: . [last accessed 12 January 2017.]
    1. World Health Organization , department of reproductive health and research. (2010). Combined hormonal contraceptive use during the postpartum period. Available from: . [last accessed 12 Jan 2017.]
    1. Young, E. A. , Kornstein, S. G. , Harvey, A. T. , Wisniewski, S. R. , Barkin, J. , … Rush, A,. J. (2007). Influences of hormone‐based contraception on depressive symptoms in premenopausal women with major depression. Psychoneuroendocrinology, 32, 843–853.

Source: PubMed

3
Subscribe