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Lai W, Liang J, Xiang Y, Hu Q, Huang J, Chen M, Chen X, Sun B, Yang Q, Deng K. Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023. Expert Opin Drug Saf 2025:1-9. [PMID: 39995329 DOI: 10.1080/14740338.2025.2472908] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Revised: 02/12/2025] [Accepted: 02/14/2025] [Indexed: 02/26/2025]
Abstract
BACKGROUND Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented. RESEARCH DESIGN AND METHODS Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs. RESULTS A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions. CONCLUSIONS Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.
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Affiliation(s)
- Wujiang Lai
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Jiemei Liang
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Ying Xiang
- Senior Department of Traditional Chinese Medicine, the Sixth Medical Center of PLA General Hospital, Beijing, China
| | - Qinqin Hu
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Jinfa Huang
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Milin Chen
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Xiting Chen
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Bin Sun
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Qian Yang
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
| | - Kaixian Deng
- Shunde Hospital, Southern Medical University (The First People's Hospital of Shunde), Foshan, China
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Li RHW, Lo SST, Cameron ST. Hormonal methods for emergency contraception. Best Pract Res Clin Obstet Gynaecol 2024; 97:102550. [PMID: 39243521 DOI: 10.1016/j.bpobgyn.2024.102550] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/14/2024] [Accepted: 09/02/2024] [Indexed: 09/09/2024]
Abstract
The World Health Organization includes oral emergency contraception (EC) in the list of essential medicines. Ulipristal acetate (UPA) and levonorgestrel (LNG) are the recommended oral methods. UPA has superior efficacy and a comparable side effect profile compared with LNG. Both work by inhibiting or delaying ovulation, so that sperm present in the reproductive tract will have lost their fertilising ability by the time the oocyte is eventually released. Neither LNG nor UPA at the EC doses have significant effects on the endometrium and are unable to prevent implantation. Mifepristone can also be used for EC but its availability is limited to few countries. LNG is less effective in women with a body mass index over 26 kg/m2 or weight over 70 kg. Hormonal contraception can be quickstarted immediately following LNG, or five days following UPA. LNG-releasing intrauterine devices and cyclo-oxygenase inhibitors are promising options for EC to be further studied.
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Affiliation(s)
- Raymond Hang Wun Li
- Department of Obstetrics and Gynaecology, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, 102 Pokfulam Road, Pokfulam, Hong Kong; The Family Planning Association of Hong Kong, 10th Floor, 130 Hennessy Road, Wan Chai, Hong Kong.
| | - Sue Seen Tsing Lo
- Department of Obstetrics and Gynaecology, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, 102 Pokfulam Road, Pokfulam, Hong Kong; The Family Planning Association of Hong Kong, 10th Floor, 130 Hennessy Road, Wan Chai, Hong Kong.
| | - Sharon Tracey Cameron
- Chalmers Sexual Health Centre, NHS Lothian, 2a Chalmers St, Edinburgh, EH3 9ES, United Kingdom; Centre for Reproductive Health, The University of Edinburgh, Edinburgh BioQuarter, Edinburgh, EH16 4UU, United Kingdom.
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Rudzinski P, Lopuszynska I, Pazik D, Adamowicz D, Jargielo A, Cieslik A, Kosieradzka K, Stanczyk J, Meliksetian A, Wosinska A. Emergency contraception - A review. Eur J Obstet Gynecol Reprod Biol 2023; 291:213-218. [PMID: 37922775 DOI: 10.1016/j.ejogrb.2023.10.035] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2023] [Revised: 10/21/2023] [Accepted: 10/30/2023] [Indexed: 11/07/2023]
Abstract
Emergency contraception (EC), or postcoital contraception, is a therapy aimed at preventing unintended pregnancy after an act of unprotected or under-protected sexual intercourse. Options include both emergency contraceptive pills (most commonly containing levonorgestrel or ulipristal acetate) and insertion of an intrauterine device. The aim of this paper is to summarize current evidence surrounding the use of emergency contraceptives and to present an evidence-based approach to EC provision. Emergency contraception is a safe and effective option in preventing unwanted pregnancy, irrespective of age, weight, or breastfeeding status. Efforts should be made to increase their availability, as well as knowledge of these methods, both among patients and healthcare providers.
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Affiliation(s)
- Patryk Rudzinski
- Independent Public Clinical Hospital Named After Prof. W. Orłowski of the Centre for Postgraduate Medical Education, Warsaw, Poland.
| | - Inga Lopuszynska
- The National Institute of Medicine of the Ministry of Interior and Administration, Warsaw, Poland
| | - Dorota Pazik
- Independent Public Clinical Hospital Named After Prof. W. Orłowski of the Centre for Postgraduate Medical Education, Warsaw, Poland
| | - Dominik Adamowicz
- University Clinical Centre of the Medical University of Warsaw, Warsaw, Poland
| | - Anna Jargielo
- Military Institute of Medicine - National Research Institute, Warsaw, Poland
| | | | | | - Justyna Stanczyk
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland
| | - Astrik Meliksetian
- The National Institute of Medicine of the Ministry of Interior and Administration, Warsaw, Poland
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Amorim RV, Barbieri MA, Bôtto-Menezes C, Carmona F, Ferraro AA, Bettiol H. Why are pediatricians uncomfortable with prescribing emergency contraception for adolescents? REVISTA PAULISTA DE PEDIATRIA : ORGAO OFICIAL DA SOCIEDADE DE PEDIATRIA DE SAO PAULO 2023; 41:e2022060. [PMID: 37255109 DOI: 10.1590/1984-0462/2023/41/2022060] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2022] [Accepted: 08/21/2022] [Indexed: 06/01/2023]
Abstract
OBJECTIVE Emergency contraception (EC) is an effective and safe method for preventing unplanned pregnancy after unprotected sexual intercourse among adolescents but is infrequently prescribed by pediatricians. Because of the scarcity of data on the discomfort with EC prescription among physicians in Brazil, this study aimed to identify associated factors with discomfort with EC prescription among pediatricians in the state of Amazonas. METHODS A web-based, cross-sectional study including sociodemographic data, knowledge, attitudes, and discomfort with EC prescription was used. Multivariate logistic regression and artificial intelligence methods such as decision tree and random forest analysis were used to identify factors associated with discomfort with EC prescriptions. RESULTS Among 151 physicians who responded to the survey, 53.0% were uncomfortable with prescribing EC, whereas only 33.1% had already prescribed it. Inexperience was significantly associated with discomfort with EC prescription (odds ratio 4.47, 95% confidence interval 1.71-11.66). Previous EC prescription was protective against discomfort with EC prescription in the three models. CONCLUSIONS EC is still infrequently prescribed by pediatricians because of inexperience and misconceptions. Training these professionals needs to be implemented as part of public health policies to reduce unplanned adolescent pregnancy.
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Affiliation(s)
| | | | - Camila Bôtto-Menezes
- Universidade do Estado do Amazonas, Manaus, AM, Brazil
- Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, AM, Brazil
| | - Fábio Carmona
- Universidade de São Paulo, Ribeirão Preto, SP, Brazil
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Li D, Hu Z, Chen Q, Chai W, Cai R, Kuang Y, Lu X. Neonatal outcomes and congenital malformations in children born after progestin-primed ovarian stimulation protocol. Front Endocrinol (Lausanne) 2022; 13:965863. [PMID: 36440198 PMCID: PMC9681814 DOI: 10.3389/fendo.2022.965863] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2022] [Accepted: 10/20/2022] [Indexed: 11/11/2022] Open
Abstract
Purpose The purpose of this study is to assess the safety of progestin-primed ovarian stimulation (PPOS) protocol regarding the neonatal outcomes and congenital malformations in babies born after in vitro fertilization (IVF) and frozen embryo transfer (FET). Methods In this large retrospective cohort study, a total of 16,493 infants born between 1 September 2013 and 31 July 2021 from IVF and FET cycles after treatment with either PPOS (n = 15,245) or gonadotropin-releasing hormone antagonist (GnRH-ant) (n = 1,248) were finally enrolled. The primary outcome measure was the incidence of congenital malformations. The secondary outcome measures were rates of low birth weight (LBW), very low birth weight (VLBW), preterm birth (PTB), very preterm birth (VPTB), and early neonatal death. Results Birth characteristics for both singletons and twins regarding the sex of infants, gestational age, birth weight, and birth length were comparable between the PPOS group and the GnRH-ant group. Rates of LBW, VLBW, PTB, VPTB, and early neonatal death were also similar. The reanalysis using propensity score matching (PSM) and multivariable logistic regression indicated that the PPOS protocol could not increase the risk of adverse neonatal outcomes compared with the GnRH-ant protocol. Furthermore, no significant difference was observed in the overall incidence of congenital malformations in live-born babies. After PSM and controlling for all confounders, the results remained insignificant with an adjusted odds ratio of 0.66 [95% confidence interval (CI) 0.32-1.34] and 2.43 [95% CI 0.97-6.06], respectively, for singletons and twins. Conclusions Our study suggests that compared with GnRH-ant treatment for IVF, the PPOS protocol could not produce a negative effect on the newborn population in terms of neonatal outcomes and congenital malformations.
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Affiliation(s)
| | | | | | | | - Renfei Cai
- Department of Assisted Reproduction, Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Yanping Kuang
- Department of Assisted Reproduction, Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xuefeng Lu
- Department of Assisted Reproduction, Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
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Emergency Contraception: Access and Challenges at Times of Uncertainty. Am J Ther 2022; 29:e553-e567. [PMID: 35998109 DOI: 10.1097/mjt.0000000000001560] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
BACKGROUND The UN Commission on Life-Saving Commodities for Women's and Children's Health identified emergency contraceptive pills as 1 of the 13 essential underused, low-cost, and high-impact commodities that could save the lives of millions of women and children worldwide. In the US, 2 emergency contraceptive regimens are currently approved, and their most plausible mechanism of action involves delaying and/or inhibiting ovulation. AREAS OF UNCERTAINTY Abortion and contraception are recognized as essential components of reproductive health care. In the US, in the wake of the Dobbs v. Jackson Women's Health Organization Supreme Court decision on June 24, 2022, 26 states began to or are expected to severely restrict abortion. It is anticipated that these restrictions will increase the demand for emergency contraception (EC). Several obstacles to EC access have been described, and these include cost, hurdles to over-the-counter purchase, low awareness, myths about their mechanisms of action, widespread misinformation, and barriers that special populations face in accessing them. The politicization of EC is a major factor limiting access. Improving sex education and health literacy, along with eHealth literacy, are important initiatives to improve EC uptake and access. DATA SOURCES PubMed, The Guttmacher Institute, Society of Family Planning, American College of Obstetrician and Gynecologists, the World Health Organization, The United Nations. THERAPEUTIC ADVANCES A randomized noninferiority trial showed that the 52 mg levonorgestrel intrauterine device was noninferior to the copper intrauterine device when used as an EC method in the first 5 days after unprotected intercourse. This is a promising and highly effective emergency contraceptive option, particularly for overweight and obese patients, and a contraceptive option with a different bleeding profile than the copper intrauterine device. CONCLUSIONS EC represents an important facet of medicine and public health. The 2 medical regimens currently approved in the US are very effective, have virtually no medical contraindications, and novel formulations are actively being investigated to make them more convenient and effective for all patient populations. Barriers to accessing EC, including the widespread presence of contraception deserts, threaten to broaden and accentuate the already existing inequities and disparities in society, at a time when they have reached the dimensions of a public health crisis.
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Effect of levonorgestrel emergency contraception on implantation and fertility: a review. Contraception 2022; 109:8-18. [DOI: 10.1016/j.contraception.2022.01.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2021] [Revised: 01/09/2022] [Accepted: 01/11/2022] [Indexed: 12/30/2022]
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Huang J, Xie Q, Lin J, Lu X, Wang N, Gao H, Cai R, Kuang Y. Neonatal outcomes and congenital malformations in children born after dydrogesterone application in progestin-primed ovarian stimulation protocol for IVF: a retrospective cohort study. DRUG DESIGN DEVELOPMENT AND THERAPY 2019; 13:2553-2563. [PMID: 31440037 PMCID: PMC6667350 DOI: 10.2147/dddt.s210228] [Citation(s) in RCA: 42] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/27/2019] [Accepted: 07/11/2019] [Indexed: 01/08/2023]
Abstract
Purpose Dydrogesterone (DYG) has been demonstrated to be an alternative progestin in the progestin-primed ovarian stimulation (PPOS) protocol with comparable oocyte retrieval and pregnancy outcomes. However, its safety regarding neonatal outcomes and congenital malformations is still unclear. Patients and methods This retrospective cohort study included 3556 live-born infants after in vitro fertilization and vitrified embryo transfer cycles using the DYG + human menopausal gonadotropin (hMG) protocol (n=1429) or gonadotropin-releasing hormone (GnRH)-agonist short protocol (n=2127) from January 2014 to December 2017. Newborn information was gathered from standardized follow-up questionnaires and/or access to medical records within 7 days after birth. Associations between ovarian stimulation protocols and outcome measures were analyzed by binary logistic regression after adjusting for confounding factors. Results In both singletons and twins, birth characteristics regarding mode of delivery, newborn gender, gestational age, birthweight, length at birth and Z-scores were comparable between the two protocols. For adverse neonatal outcomes, the two protocols showed no significant differences on the rates of low birthweight, very low birthweight, preterm birth, very preterm birth, small-for-gestational age, large-for-gestational age and early neonatal death after adjustment. Furthermore, the incidence of major congenital malformations in the DYG + hMG protocol (1.12%) was similar to that in the GnRH-agonist short protocol (1.08%), with the adjusted odds ratio of 0.98 (95% confidence interval [CI]: 0.40–2.39) and 0.90 (95% CI: 0.33–2.41) in singletons and twins, respectively. Conclusion Our data suggested that compared with the conventional GnRH-agonist short protocol, application of DYG in the PPOS protocol was a safe option for the newborn population without compromising neonatal outcomes or increasing congenital malformation risks.
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Affiliation(s)
- Jialyu Huang
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Qin Xie
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Jiaying Lin
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Xuefeng Lu
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Ningling Wang
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Hongyuan Gao
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Renfei Cai
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
| | - Yanping Kuang
- Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, People's Republic of China
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Clinical Pharmacology of Hormonal Emergency Contraceptive Pills. Int J Reprod Med 2018; 2018:2785839. [PMID: 30402457 PMCID: PMC6193352 DOI: 10.1155/2018/2785839] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2018] [Accepted: 09/02/2018] [Indexed: 12/30/2022] Open
Abstract
Emergency contraceptives play a major role in preventing unwanted pregnancy. The use of emergency contraceptives is characterized by myths and lack of knowledge by both health professionals and users. The main objective of this paper is to summarize the clinical pharmacology of hormonal methods of emergency contraception. A literature review was done to describe in detail the mechanism of action, efficacy, pharmacokinetics, safety profile, and drug interactions of hormonal emergency contraceptive pills. This information is useful to healthcare professionals and users to fully understand how hormonal emergency contraceptive methods work.
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Hamdaoui N, Cardinale C, Agostini A. [Emergency contraception: CNGOF Contraception Guidelines]. ACTA ACUST UNITED AC 2018; 46:799-805. [PMID: 30389544 DOI: 10.1016/j.gofs.2018.10.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2018] [Indexed: 11/17/2022]
Abstract
OBJECTIVES Edit, by the French National College of Gynecologists and Obstetricians (CNGOF), recommendations based on the evidence available in the literature for the use in terms of effectiveness, safety and side effects of emergency contraception (EC). METHODS A review of the literature was conducted by consulting Medline, Cochrane Library and international recommendations in French and English from January 1, 1979 to May 1, 2018. RESULTS It is recommended to inform patients that EC is not 100% effective. A pregnancy test is recommended if there is a delay after taking an EC. It is recommended to use EC as soon as possible after the unprotected intercourse. In the absence of long-term contraception, in the first 72hours after unprotected intercourse, ulipristal acetate (UPA) and levonorgestrel (LNG) may be offered with a superiority of UPA from 0 to 72h. Beyond 72hours, the data suggest a better efficiency of the UPA. However, taking into account practical elements (access to EC, cost, impact on the taking of hormonal contraception after UPA), it is difficult to recommend the UPA as a priority between 0 and 72h. Menstruation is more likely to happen early with LNG. The copper IUD is an effective method that can be used in EC until 120hours after unprotected intercourse or when there is a risk of contraceptive failure. CONCLUSIONS EC is not 100% effective. The closer the intake of EC with the unprotected intercourse, the more effective is the EC in terms of pregnancy rate.
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Affiliation(s)
- N Hamdaoui
- Service de gynécologie-obstétrique, hôpital de la Conception, boulevard Baille, 13005 Marseille, France.
| | - C Cardinale
- Service de gynécologie-obstétrique, hôpital de la Conception, boulevard Baille, 13005 Marseille, France
| | - A Agostini
- Service de gynécologie-obstétrique, hôpital de la Conception, boulevard Baille, 13005 Marseille, France
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Beelen P, Suykerbuyk–de Hoog DE, Jager W, Geomini PM. Pregnancy in a Patient with an Intra-Abdominal Levonorgestrel-Releasing Intrauterine System. J Gynecol Surg 2018. [DOI: 10.1089/gyn.2017.0128] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Affiliation(s)
- Pleun Beelen
- Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands
- Grow-School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands
| | | | - Waltje Jager
- Department of Obstetrics and Gynaecology, St. Jans Gasthuis, Weert, The Netherlands
| | - Peggy M.A.J Geomini
- Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands
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Neonatal outcomes and congenital malformations in children born after human menopausal gonadotropin and medroxyprogesterone acetate treatment cycles. Arch Gynecol Obstet 2017; 296:1207-1217. [PMID: 28948397 DOI: 10.1007/s00404-017-4537-z] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2017] [Accepted: 09/14/2017] [Indexed: 12/11/2022]
Abstract
PURPOSE To investigate neonatal outcomes and congenital malformations in children born after in vitro fertilization (IVF) and vitrified embryo transfer cycles using human menopausal gonadotrophin and medroxyprogesterone acetate (hMG + MPA) treatment. METHODS We performed a retrospective cohort study including 4596 live born babies. During January 2014-June 2016, children born after either hMG + MPA treatment, gonadotropin releasing hormone agonist short protocol, or mild ovarian stimulation were included. The main outcome measures were neonatal outcomes and congenital malformations. RESULTS Neonatal outcomes both for singletons and twins such as mean birth weight and length, gestational age, the frequency of preterm birth were comparable between groups. Rate of stillbirth and perinatal death were also similar. No significant differences were found in the overall incidence of congenital malformations between the three groups. Multivariable logistic regression indicated that hMG + MPA regimen did not significantly increase the risk of congenital malformations compared with short protocol and mild ovarian stimulation, with adjusted odds ratio of 1.22 [95% confidence interval (CI) 0.61-2.44] and 1.38 (CI 0.65-2.93), respectively, after adjusting for confounding factors. CONCLUSIONS Our data suggested that compared with conventional ovarian stimulations, hMG + MPA treatment neither compromised neonatal outcomes of IVF newborns, nor did increase the prevalence of congenital malformations.
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Lee JK, Schwarz EB. The safety of available and emerging options for emergency contraception. Expert Opin Drug Saf 2017; 16:1163-1171. [PMID: 28730840 DOI: 10.1080/14740338.2017.1354985] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
INTRODUCTION Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regarding the safety of EC as well as directions for further study. PubMed was searched for all relevant studies published prior to June 2017. Expertopinion: All available methods of EC (i.e., ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown. The copper IUD has the highest efficacy of EC methods. Given the excellent safety profiles of mifepristone and the levonorgestrel IUD, research is ongoing related to use of these products for EC.
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Affiliation(s)
- Jessica K Lee
- a Department of Obstetrics and Gynecology , Johns Hopkins University , Baltimore , MD , USA
| | - Eleanor Bimla Schwarz
- b Department of General Internal Medicine , UC Davis, Division of General Internal Medicine , Sacramento , CA , USA
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Cameron ST, Li HWR, Gemzell-Danielsson K. Current controversies with oral emergency contraception. BJOG 2017; 124:1948-1956. [DOI: 10.1111/1471-0528.14773] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/29/2017] [Indexed: 12/30/2022]
Affiliation(s)
- ST Cameron
- Chalmers Sexual and Reproductive Health Centre; Edinburgh UK
| | - HWR Li
- Department of Obstetrics and Gynaecology; University of Hong Kong; Queen Mary Hospital; Hong Kong Hong Kong
- Shenzhen Key Laboratory of Fertility Regulation; Reproductive Medicine Centre; The University of Hong Kong-Shenzhen Hospital; Shenzhen China
| | - K Gemzell-Danielsson
- Shenzhen Key Laboratory of Fertility Regulation; Reproductive Medicine Centre; The University of Hong Kong-Shenzhen Hospital; Shenzhen China
- Department of Women's and Children's Health; Division of Obstetrics and Gynaecology; Karolinska Institutet; Karolinska University Hospital; Stockholm Sweden
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15
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Ozturk Z, Akgul E. Pregnancy Outcomes Following Ulipristal Acetate Emergency Contraception Failure: A Report of Five Cases. Fetal Pediatr Pathol 2017; 36:213-219. [PMID: 28368774 DOI: 10.1080/15513815.2017.1303010] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
INTRODUCTION The emergency contraceptive ulipristal acetate (UPA) 30 mg is increasingly used by women, but there is no published data on UPA exposure in pregnancy. CASE REPORT Here we describe five cases of unintended pregnancies following the use of UPA for emergency contraception. Of five pregnant women exposed to UPA, one decided to terminate the pregnancy for personal reasons. Two of them experienced premature rupture of membranes and the babies were born large for gestational age (LGA). The other two women experienced gestational diabetes, and one of them also delivered a LGA baby. The blood glucose levels of the mothers were normal after delivery and at six weeks postpartum. No birth defects and no growth or developmental abnormalities for the infants were reported during 6 months follow-up. CONCLUSION Pregnant women inadvertently exposed to UPA should be monitored carefully, unless further data are available.
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Affiliation(s)
- Zeynep Ozturk
- a Department of Clinical Pharmacology and Toxicology , Izmir Atatürk Research Hospital , Izmir , Turkey
| | - Emine Akgul
- a Department of Clinical Pharmacology and Toxicology , Izmir Atatürk Research Hospital , Izmir , Turkey
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Contraception d’urgence. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2016; 38:S143-S152. [DOI: 10.1016/j.jogc.2016.09.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
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García-Calvente MDM, Lomas-Hernández V. Anticoncepción de urgencia y objeción de conciencia: un debate sin cerrar. GACETA SANITARIA 2016; 30:91-3. [DOI: 10.1016/j.gaceta.2015.12.007] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/14/2015] [Revised: 12/04/2015] [Accepted: 12/21/2015] [Indexed: 01/18/2023]
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Zhang D, Yan MX, Ma J, Xia W, Xue RH, Sun J, Zhang J. Association between knowledge about levonorgestrel emergency contraception and the risk of ectopic pregnancy following levonorgestrel emergency contraception failure: a comparative survey. Pharmacoepidemiol Drug Saf 2016; 25:880-8. [PMID: 26748685 PMCID: PMC5064746 DOI: 10.1002/pds.3946] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2015] [Revised: 11/17/2015] [Accepted: 11/25/2015] [Indexed: 11/10/2022]
Abstract
Objective To study the association between knowledge about levonorgestrel emergency contraception (LNG‐EC) and the risk of ectopic pregnancy (EP) following LNG‐EC failure. Methods This study included 600 women who had visited the hospital with LNG‐EC failure. Of these, 300 with EP and 300 with intrauterine pregnancy (IUP) were recruited to the EP group and IUP group respectively. The participants were interviewed face‐to‐face using a standardized questionnaire. Main Outcome Measures Pearson's chi‐square tests and t‐test were used to compare the sociodemographic characteristics, reproductive and gynecological history, surgical history, previous contraceptive experience, and answers to 10 questions concerning the knowledge about LNG‐EC. Results Those who gave incorrect answers to the question regarding the basic mechanism and specific method of levonorgestrel emergency contraceptive pills (LNG‐ECPs) were at a higher risk of EP after LNG‐EC failure. Women who did not strictly follow instructions or advice from healthcare professionals were more likely to subsequently experience EP (p < 10−4). Women with LNG‐EC failure reported friends/peers, TV, and Internet as the main sources of information. No difference was observed with regard to the sources of knowledge on LNG‐EC (p = 0.07). Conclusions The results illustrate the importance of strictly following the doctor's guidance or drug instructions when using LNG‐ECPs. The media should be used to disseminate information about responsible EC, and pharmacy staff should receive regular educational training sessions in this regard. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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Affiliation(s)
- Duo Zhang
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Ming-Xing Yan
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Jue Ma
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Wei Xia
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Rui-Hong Xue
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Jing Sun
- Department of Obstetrics and Gynecology, Shanghai First Maternity and Infant Hospital, Tong Ji University School of Medicine, Shanghai, China
| | - Jian Zhang
- Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.,Institute of Embryo-Fetal Original Adult Disease Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
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Kelekci S, Aydogmus S. Emergency contraception: What is new? World J Obstet Gynecol 2015; 4:95-101. [DOI: 10.5317/wjog.v4.i4.95] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/11/2015] [Revised: 07/19/2015] [Accepted: 09/08/2015] [Indexed: 02/05/2023] Open
Abstract
Unintended pregnancy rates remain high throughout the World and increase the risk of poor maternal and infant outcomes. Most of unintended pregnancies occur in women who were not using contraception or who became pregnant despite the reported use of contraception. Women who have had recent unprotected intercourse including those who have had another form of contraception fail are potential candidates for this intervention. Currently used emergency contraceptive methods are pills that contain combined estrogen-progesterone, only progestin, antiprogestins and copper intrauterine devices. The most common form of this type of contraception is oral progestin-only pills (levonorgestrel). The most effective method is copper intrauterine devices followed by anti-progestins and oral progestin-only pills. The major pathogenesis of oral emergency contraceptives is the prevention or delay of ovulation. Although conception is possible on only a few days of the cycle, emergency contraception is offered when indicated without regard to the timing of the menstrual cycle because of uncertainty in the timing of the ovulation. Levonorgestrel and E/P regimes are most effective as soon as possible after unprotected sexual intercourse. A linear relationship has been shown between effectiveness and the time of dose. The effectiveness continues for 120 h, but it is recommended to be used within 72 h after intercourse. Intrauterine devices may prevent pregnancy when 5 d after ovulation.
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Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Contraception 2015; 93:93-112. [PMID: 26546020 DOI: 10.1016/j.contraception.2015.11.001] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2015] [Revised: 10/23/2015] [Accepted: 11/01/2015] [Indexed: 12/30/2022]
Abstract
UNLABELLED The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) provide recommendations for use of emergency contraceptive pills (ECPs), including levonorgestrel (LNG) and combined oral contraceptives (COCs). A new ECP formulation, ulipristal acetate (UPA), is now available worldwide. To determine whether LNG, UPA or COC (Yuzpe) ECPs are safe for women with certain characteristics or medical conditions, we searched the PubMed and Cochrane databases for articles published from date of inception until May 2015 pertaining to the safety of LNG, UPA or Yuzpe ECP use. For direct evidence, we considered studies that looked at safety outcomes among women with certain medical conditions or characteristics taking ECPs compared with women not taking ECPs. For indirect evidence, we considered studies that reported pharmacokinetic (PK) data for ECP use among women with certain medical conditions or characteristics and studies that reported safety outcomes among healthy women taking ECPs. Five studies provided direct evidence; of these five studies, four examined LNG or Yuzpe use among pregnant or breastfeeding women, and one reported risk of ectopic pregnancy among women repeatedly using LNG ECPs. Poor pregnancy outcomes were rare among pregnant women who used LNG or Yuzpe ECPs during the conception cycle or early pregnancy. Breastfeeding outcomes did not differ between women exposed to LNG ECP and those unexposed, and there was no increased risk of ectopic pregnancy versus intrauterine pregnancy after repeated use of LNG ECPs compared with nonuse. Forty-five studies provided indirect evidence. One PK study demonstrated that LNG passes into breastmilk but in minimal quantities. In addition, nine studies examined pregnancy outcomes following ECP failure among healthy women, and 35 articles reported adverse events. Studies suggest that serious adverse events are rare among women taking any of these ECP formulations. IMPLICATIONS Evidence on safety of ECPs among women with characteristics or medical conditions listed within WHO and CDC family planning guidance is limited. However, both direct and indirect evidence for our study question did not suggest any special safety concerns for the use of ECPs among women with particular medical conditions or personal characteristics, such as pregnancy, lactation or frequent ECP use.
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Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril 2015; 104:62-70.e3. [PMID: 25956370 DOI: 10.1016/j.fertnstert.2015.03.022] [Citation(s) in RCA: 268] [Impact Index Per Article: 26.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2014] [Revised: 03/14/2015] [Accepted: 03/23/2015] [Indexed: 11/22/2022]
Abstract
OBJECTIVE To investigate the use of medroxyprogesterone acetate (MPA) to prevent LH surge during controlled ovarian hyperstimulation (COH) and to compare cycle characteristics and pregnancy outcomes in subsequently frozen-thawed ET (FET) cycles. DESIGN A prospective controlled study. SETTING Tertiary-care academic medical center. PATIENT(S) Three hundred patients undergoing IVF/intracytoplasmic sperm injection treatment. INTERVENTION(S) In the study group, hMG and MPA were administered simultaneously beginning on cycle day 3. Ovulation was induced with a GnRH agonist or cotriggered by a GnRH agonist and hCG when dominant follicles matured. A short protocol was used in the control group. Viable embryos were cryopreserved for later transfer in both protocols. MAIN OUTCOME MEASURE(S) The primary outcome measure was the number of oocytes retrieved. Secondary outcomes included the number of mature oocytes, the incidence of premature LH surge, and clinical pregnancy outcomes from FETs. RESULT(S) The number of oocytes retrieved in the study group was similar to those in the controls (9.9 ± 6.7 vs. 9.0 ± 6.0), and higher doses of hMG were administered. In the study group, LH suppression persisted during ovarian stimulation, and the incidence of premature LH surge was 0.7% (1/150). No statistically significant differences were found in the clinical pregnancy rates (47.8% vs. 43.3%), implantation rates (31.9% vs. 27.7%), and live-birth rates (42.6% vs. 35.5%) in the study group and controls. CONCLUSION(S) The results show that MPA is an effective oral alternative for the prevention of premature LH surge in woman undergoing COH. This finding will help establish a new regimen for ovarian stimulation in combination with embryo cryopreservation. CLINICAL TRIAL REGISTRATION NUMBER ChiCTR-ONRC-14004419.
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Cleland K, Raymond EG, Westley E, Trussell J. Emergency contraception review: evidence-based recommendations for clinicians. Clin Obstet Gynecol 2014; 57:741-50. [PMID: 25254919 PMCID: PMC4216625 DOI: 10.1097/grf.0000000000000056] [Citation(s) in RCA: 46] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
Several options for emergency contraception are available in the United States. This article describes each method, including efficacy, mode of action, safety, side effect profile, and availability. The most effective emergency contraceptive is the copper intrauterine device (IUD), followed by ulipristal acetate and levonorgestrel pills. Levonorgestrel is available for sale without restrictions, whereas ulipristal acetate is available with prescription only, and the copper IUD must be inserted by a clinician. Although EC pills have not been shown to reduce pregnancy or abortion rates at the population level, they are an important option for individual women seeking to prevent pregnancy after sex.
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Affiliation(s)
- Kelly Cleland
- Office of Population Research, Princeton University, Princeton, NJ
| | | | | | - James Trussell
- Office of Population Research, Princeton University, Princeton, NJ
- The Hull York Medical School, University of Hull, Hull England
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Carvajal A, Sáinz M, Velasco V, García Ortega P, Treceño C, Martín Arias LH, Pellón M, García Sevillano L. Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting. Pharmacoepidemiol Drug Saf 2014; 24:93-7. [PMID: 25408302 DOI: 10.1002/pds.3725] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2014] [Revised: 08/02/2014] [Accepted: 09/22/2014] [Indexed: 02/05/2023]
Abstract
BACKGROUND The emergency contraceptive pill (ECP) containing levonorgestrel is dispensed without a prescription in Spain since 2009. An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events. The aim of the present study is to further learn the adverse effects of this ECP. METHODS An ad hoc follow-up study was carried out in three community pharmacies in a city of Central Spain; the sample was composed of those women asking for the ECP; they were interviewed by telephone after at least a month since the last menses. We completed the safety profile obtained with that coming from spontaneous reporting in Spain. RESULTS Out of 139 women surveyed, 113 developed any adverse event--two considered as severe; the most frequently reported events were menstrual disturbances, which accounted for 21% of all events. Through spontaneous reporting, 36 cases of whatever adverse events related to levonorgestrel as ECP were identified. Twenty-five cases were considered as severe. Both types of reaction and severity were significantly different in the follow-up study and in the spontaneous reporting. Some of the reactions identified, such as miscarriage, febrile neutropenia, and porphyria, are not included in the Summary of Product Characteristics. CONCLUSIONS Levonorgestrel as an ECP is mostly safe. Attention should be paid to some severe events and particularly to those risk factors for them to appear. Combining spontaneous reporting with an ad hoc follow-up study, the whole safety profile of a given medication can be obtained.
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Affiliation(s)
- Alfonso Carvajal
- Centro de Estudios sobre la Seguridad de los Medicamentos (CESME), Universidad de Valladolid, Valladolid, Spain
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Abstract
This review gives an overview of the mechanisms of action of oral emergency contraception pills (ECPs), focusing on the levonorgestrel (LNG) and ulipristal acetate (UPA) containing ECPs. In vivo and in vitro studies have addressed the effect of EC on various possible targets. Based on these studies as well as on clinical trials it is clear that the efficacy of ECPs to prevent an unintended pregnancy depends on their mechanism of action as well as on their use in relation to the fertile window. While the main effect of both available ECPs is to prevent or delay ovulation the window of action for UPA is wider than that of LNG. This provides the biological explanation for the difference observed in clinical trials and the higher efficacy of UPA. Neither LNG nor UPA impairs endometrial receptivity or embryo implantation. Correct knowledge on the mechanism of action of ECPs is important to avoid overestimating their effectiveness and to advise women on correct use.
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Affiliation(s)
- Kristina Gemzell-Danielsson
- Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, Karolinska University Hospital , Stockholm , Sweden
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Thomin A, Keller V, Daraï E, Chabbert-Buffet N. Consequences of emergency contraceptives: the adverse effects. Expert Opin Drug Saf 2014; 13:893-902. [DOI: 10.1517/14740338.2014.921678] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
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Shohel M, Rahman MM, Zaman A, Uddin MMN, Al-Amin MM, Reza HM. A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception. BMC Womens Health 2014; 14:54. [PMID: 24708837 PMCID: PMC3977662 DOI: 10.1186/1472-6874-14-54] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2013] [Accepted: 03/30/2014] [Indexed: 12/21/2022] Open
Abstract
BACKGROUND Unintended pregnancy is a complex phenomenon which raise to take an emergency decision. Low contraceptive prevalence and high user failure rates are the leading causes of this unexpected situation. High user failure rates suggest the vital role of emergency contraception to prevent unplanned pregnancy. Levonorgestrel - a commonly used progestin for emergency contraception. However, little is known about its pharmacokinetics and optimal dose for use. Hence, there is a need to conduct a systematic review of the available evidences. METHODS Randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 h of unprotected coitus, to one of three regimens: 1.5 mg single dose levonorgestrel, two doses of 0.75 mg levonorgestrel given 12 h apart or two doses of 0.75 mg levonorgestrel given 24 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. RESULTS Every trial under consideration successfully established the contraceptive effectiveness of levonorgestrel for preventing unintended pregnancy. Moreover, a single dose of levonorgestrel 1.5 mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75 mg are intended for administration, the second dose can positively be taken 12-24 h after the first dose without compromising its contraceptive efficacy. The main side effect was frequent menstrual irregularities. No serious adverse events were reported. CONCLUSIONS The review shows that, emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen. All the regimens studied were very efficacious for emergency contraception and prevented a high proportion of pregnancies if taken within 72 h of unprotected coitus. Single levonorgestrel dose (1.5 mg) can substitute two 0.75 mg doses 12 or 24 h apart. With either regimen, the earlier the treatment is given, the more effective it seems to be.
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Affiliation(s)
- Mohammad Shohel
- Department of Pharmaceutical Sciences, North South University, Dhaka 1229, Bangladesh
| | | | - Asif Zaman
- Department of Pharmaceutical Sciences, North South University, Dhaka 1229, Bangladesh
| | | | - Md Mamun Al-Amin
- Department of Pharmaceutical Sciences, North South University, Dhaka 1229, Bangladesh
| | - Hasan Mahmud Reza
- Department of Pharmaceutical Sciences, North South University, Dhaka 1229, Bangladesh
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Westley E, Kapp N, Palermo T, Bleck J. A review of global access to emergency contraception. Int J Gynaecol Obstet 2013; 123:4-6. [PMID: 23856676 DOI: 10.1016/j.ijgo.2013.04.019] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2013] [Accepted: 06/24/2013] [Indexed: 11/27/2022]
Abstract
BACKGROUND Emergency contraception has been known for several decades, and dedicated products have been on the market for close to 20 years. Yet it is unclear whether women, particularly in low-resource countries, have access to this important second-chance method of contraception. OBJECTIVES To review relevant policies, regulations, and other factors related to access to emergency contraception worldwide. SEARCH STRATEGY A wide range of gray literature was reviewed, several specific studies were commissioned, and a number of online databases were searched. MAIN RESULTS Several positive policies and regulations are in place: emergency contraception products are registered in the majority of countries around the world, listed in many countries' essential medicines lists, included in widely used guidance, and supported by most donors. Yet analysis of demographic data shows that the majority of women in low-income countries have never heard of emergency contraception, and surveys find that many providers have negative attitudes toward providing emergency contraception. CONCLUSIONS Despite more than a decade of concerted international and country-level efforts to ensure that women have access to emergency contraception, accessibility remains limited.
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Huang C, Zhang M, Meng C, Shi W, Sun L, Zhang J. Expressions of candidate molecules in the human fallopian tube and chorionic villi of tubal pregnancy exposed to levonorgestrel emergency contraception. Reprod Biol Endocrinol 2013; 11:46. [PMID: 23687977 PMCID: PMC3671131 DOI: 10.1186/1477-7827-11-46] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2013] [Accepted: 05/15/2013] [Indexed: 12/30/2022] Open
Abstract
BACKGROUND Cases of ectopic pregnancy (EP) following levonorgestrel (LNG) emergency contraception (EC) failure were reported, however, the effects of LNG on tubal microenvironment or chorionic villi in EP have not yet been documented. METHODS Fifty-five women with tubal pregnancy were divided into two groups according to whether LNG-EC was administrated during the cycle of conception. The serum concentrations of beta-hCG, E2 and P were measured. The mRNA and protein expressions of estrogen and progesterone receptors, leukemia inhibitory factor, vascular endothelial growth factor, inducible nitric oxide synthase, and endocannabinoid receptor - CB1 in the ectopic implantation site and chorionic villi were examined. RESULTS Compared to those unexposed to LNG-EC, women with tubal pregnancy exposed to LNG-EC during the cycle of conception had no statistically significances in the serum concentrations of beta-hCG, E2 P, nor in the pathological types of tubal pregnancy or the expressions of ER-alpha, PR, LIF, VEGF, iNOS and CB1. CONCLUSIONS The expressions of candidate molecules in the fallopian tube and chorionic villi were not altered by exposure to LNG-EC. A routine therapy with no additional intervention might thus be applied to tubal pregnancy exposed to LNG-EC.
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Affiliation(s)
- Changxiao Huang
- Department of Obstetrics and Gynaecology, International Peace Maternity and Child Health Hospital/School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Mei Zhang
- Department of Pathology, Key Laboratory of Cell Differentiation and Apoptosis of Chinese Ministry of Education, Institutes of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Chunxia Meng
- Department of Medical Pharmacology and Physiology, School of Medicine, University of Missouri-Columbia, Columbia MO, USA
| | - Wei Shi
- Department of Obstetrics and Gynaecology, International Peace Maternity and Child Health Hospital/School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Lulu Sun
- Department of Obstetrics and Gynaecology, International Peace Maternity and Child Health Hospital/School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Jian Zhang
- Department of Obstetrics and Gynaecology, International Peace Maternity and Child Health Hospital/School of Medicine, Shanghai Jiao Tong University, Shanghai, China
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Gemzell-Danielsson K, Berger C, P.G.L. L. Emergency contraception — mechanisms of action. Contraception 2013; 87:300-8. [DOI: 10.1016/j.contraception.2012.08.021] [Citation(s) in RCA: 98] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2012] [Accepted: 08/20/2012] [Indexed: 12/30/2022]
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Koyama A, Hagopian L, Linden J. Emerging options for emergency contraception. CLINICAL MEDICINE INSIGHTS. REPRODUCTIVE HEALTH 2013; 7:23-35. [PMID: 24453516 PMCID: PMC3888080 DOI: 10.4137/cmrh.s8145] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
Emergency post-coital contraception (EC) is an effective method of preventing pregnancy when used appropriately. EC has been available since the 1970s, and its availability and use have become widespread. Options for EC are broad and include the copper intrauterine device (IUD) and emergency contraceptive pills such as levonorgestrel, ulipristal acetate, combined oral contraceptive pills (Yuzpe method), and less commonly, mifepristone. Some options are available over-the-counter, while others require provider prescription or placement. There are no absolute contraindications to the use of emergency contraceptive pills, with the exception of ulipristal acetate and mifepristone. This article reviews the mechanisms of action, efficacy, safety, side effects, clinical considerations, and patient preferences with respect to EC usage. The decision of which regimen to use is influenced by local availability, cost, and patient preference.
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Affiliation(s)
- Atsuko Koyama
- Department of Pediatric Emergency Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA
| | - Laura Hagopian
- Department of Emergency Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA
| | - Judith Linden
- Department of Emergency Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA
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Abstract
Despite significant declines over the past 2 decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations. Use of emergency contraception can reduce the risk of pregnancy if used up to 120 hours after unprotected intercourse or contraceptive failure and is most effective if used in the first 24 hours. Indications for the use of emergency contraception include sexual assault, unprotected intercourse, condom breakage or slippage, and missed or late doses of hormonal contraceptives, including the oral contraceptive pill, contraceptive patch, contraceptive ring (ie, improper placement or loss/expulsion), and injectable contraception. Adolescents younger than 17 years must obtain a prescription from a physician to access emergency contraception in most states. In all states, both males and females 17 years or older can obtain emergency contraception without a prescription. Adolescents are more likely to use emergency contraception if it has been prescribed in advance of need. The aim of this updated policy statement is to (1) educate pediatricians and other physicians on available emergency contraceptive methods; (2) provide current data on safety, efficacy, and use of emergency contraception in teenagers; and (3) encourage routine counseling and advance emergency-contraception prescription as 1 part of a public health strategy to reduce teen pregnancy. This policy focuses on pharmacologic methods of emergency contraception used within 120 hours of unprotected or underprotected coitus for the prevention of unintended pregnancy. Emergency contraceptive medications include products labeled and dedicated for use as emergency contraception by the US Food and Drug Administration (levonorgestrel and ulipristal) and the "off-label" use of combination oral contraceptives.
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Abstract
Emergency contraception (EC) is any method used after sexual intercourse to prevent pregnancy. This article provides an overview of the history of EC methods and describes the current availability of oral and intrauterine EC. Oral forms include the Yuzpe regimen (combining ethinyl estradiol and levonorgestrel), levonorgestrel-only pills, and ulipristal acetate, which is a new emergency contraceptive drug recently approved by the US Food and Drug Administration. The copper T-380A intrauterine device can also be used for EC. Information about dosing, timing, access, and other considerations in the provision of EC is covered. Clinicians should be aware of all available options in order to counsel women in need of EC appropriately.
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Gizzo S, Fanelli T, Di Gangi S, Saccardi C, Patrelli TS, Zambon A, Omar A, D'Antona D, Nardelli GB. Nowadays which emergency contraception? Comparison between past and present: latest news in terms of clinical efficacy, side effects and contraindications. Gynecol Endocrinol 2012; 28:758-63. [PMID: 22390259 DOI: 10.3109/09513590.2012.662546] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Abstract
Despite many highly effective methods of contraception are available nowadays, many pregnancies are unintended. Emergency contraception (EC) is the use of drug or device after unprotected intercourse to prevent an unwanted pregnancy. It is a woman's last chance to prevent unintended pregnancy. Nevertheless the confusion about mechanisms of action, side effects, clinical efficacy and controindications makes the intervention underused in every setting investigated. So far levonorgestrel (LNG) has been considered the gold standard for oral EC. Today, a new type of second generation progesterone receptor modulator, ulipristal acetate (UPA) has been proposed as a more effective drug than LNG in prevention of unwanted pregnancies by delaying or inhibiting ovulation; even if many other devices are disposable in commerce. We revised the literature to concern most of the data available on the role of EC and moreover clarifying the available methods, the action windows of the accessible devices, the adverse events and the controindications.
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Affiliation(s)
- Salvatore Gizzo
- Department of Gynecological Sciences and Human Reproduction, University of Padua, Italy.
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Abstract
OBJECTIVE To review current knowledge about emergency contraception (EC), including available options, their modes of action, efficacy, safety, and the effective provision of EC within a practice setting. OPTIONS The combined estradiol-levonorgestrel (Yuzpe regimen) and the levonorgestrel-only regimen, as well as post-coital use of copper intrauterine devices, are reviewed. OUTCOMES Efficacy in terms of reduction in risk of pregnancy, safety, and side effects of methods for EC and the effect of the means of access to EC on its appropriate use and the use of consistent contraception. EVIDENCE Studies published in English between January 1998 and March 2010 were retrieved though searches of Medline and the Cochrane Database, using appropriate key words (emergency contraception, post-coital contraception, emergency contraceptive pills, post-coital copper IUD). Clinical guidelines and position papers developed by health or family planning organizations were also reviewed. VALUES The studies reviewed were classified according to criteria described by the Canadian Task Force on Preventive Health Care, and the recommendations for practice were ranked according to this classification (Table 1). BENEFITS, HARMS, AND COSTS These guidelines are intended to help reduce unintended pregnancies by increasing awareness and appropriate use of EC. SPONSOR The Society of Obstetricians and Gynaecologists of Canada. Summary Statements 1. Hormonal emergency contraception may be effective if used up to 5 days after unprotected intercourse. (II-2) 2. The earlier hormonal emergency contraception is used, the more effective it is. (II-2) 3. A copper IUD can be effective emergency contraception if used within 7 days after intercourse. (II-2) 4. Levonorgestrel emergency contraception regimens are more effective and cause fewer side effects than the Yuzpe regimen. (I) 5. Levonorgestrel emergency contraception single dose (1.5 mg) and the 2-dose levonorgestrel regimen (0.75 mg 12 hours apart) have similar efficacy with no difference in side effects. (I) 6. Of the hormonal emergency contraception regimens available in Canada, levonorgestrel-only is the drug of choice. (I) 7. A pregnancy that results from failure of emergency contraception need not be terminated (I) Recommendations 1. Emergency contraception should be used as soon as possible after unprotected sexual intercourse. (II-2A) 2. Emergency contraception should be offered to women if unprotected intercourse has occurred within the time it is known to be effective (5 days for hormonal methods and up to 7 days for a copper IUD). (II-2B) 3. Women should be evaluated for pregnancy if menses have not begun within 21 days following emergency contraception treatment. (III-A) 4. During physician visits for periodic health examinations or reproductive health concerns, any woman in the reproductive age group who has not been sterilized may be counselled about emergency contraception in advance with detailed information about how and when to use it. (III-C).
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Spezielle Arzneimitteltherapie in der Schwangerschaft. ARZNEIMITTEL IN SCHWANGERSCHAFT UND STILLZEIT 2012. [PMCID: PMC7271212 DOI: 10.1016/b978-3-437-21203-1.10002-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
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Cook J, Martin A, Warren O, Tan TL. Term pregnancy with LNG-IUS embedded in the rectal mucosa. J OBSTET GYNAECOL 2011; 31:546. [DOI: 10.3109/01443615.2011.584643] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
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Schmitz G, Tibbles C. Genitourinary emergencies in the nonpregnant woman. Emerg Med Clin North Am 2011; 29:621-35. [PMID: 21782078 DOI: 10.1016/j.emc.2011.04.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
Lower abdominal and pelvic pains are common symptoms in women who present to the emergency department (ED). Once pregnancy has been ruled out, attention should focus on other potential life or fertility threats. Ultrasound remains the most helpful initial diagnostic modality. Time-sensitive and serious conditions, such as large ovarian masses or abnormal vaginal bleeding, need gynecologic consultation. Because many patients do not have access to primary care, ED physicians should be familiar with the treatment of sexually transmitted diseases. However, most nonpregnant women with pelvic complaints can safely be managed in the outpatient setting after ED evaluation.
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Affiliation(s)
- Gillian Schmitz
- Department of Emergency Medicine, Georgetown University, Washington Hospital Center, Washington, DC 20010, USA.
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Wiegratz I, Thaler CJ. Hormonal contraception--what kind, when, and for whom? DEUTSCHES ARZTEBLATT INTERNATIONAL 2011; 108:495-505; quiz 506. [PMID: 21814535 PMCID: PMC3149298 DOI: 10.3238/arztebl.2011.0495] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/09/2010] [Accepted: 06/20/2011] [Indexed: 12/12/2022]
Abstract
BACKGROUND In Germany today, one-third of the 20 million women of child-bearing age use combined oral contraceptives (COCs). In this article, we summarize the current knowledge of the mode of action, wanted and unwanted side effects, and long-term risks of COCs. The levonorgestrel intrauterine device (IUD) and long-acting injectable or implantable monophasic progestogen preparations offer comparable contraceptive efficacy to COCs. Nonetheless, they are less frequently used in Germany than COCs, because of their propensity to cause breakthrough bleeding. METHOD Selective review of the literature. RESULTS COCs suppress gonadotropin secretion and thereby inhibit follicular maturation and ovulation. Their correct use is associated with 0.3 pregnancies per 100 women per year, their typical use, with 1 pregnancy per 100 women per year (Pearl index). COCs have effects on the cardiovascular and hemostatic systems as well as on lipid and carbohydrate metabolism. When given in the presence of specific risk factors, they significantly increase the likelihood of cardiovascular disease and thromboembolism. Women with persistent human papilloma virus (HPV) infection who take COCs are at increased risk of developing invasive cervical cancer. On the other hand, COCs lower the cumulative incidence of endometrial and ovarian cancer by 30% to 50%, and that of colorectal cancer by 20% to 30%. Other malignancies seem to be unaffected by COC use. CONCLUSION As long as personal and familial risk factors are carefully considered, COCs constitute a safe, reversible, and well-tolerated method of contraception.
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MESH Headings
- Cardiovascular Diseases/chemically induced
- Contraceptives, Oral, Combined/administration & dosage
- Contraceptives, Oral, Combined/adverse effects
- Contraceptives, Oral, Hormonal/administration & dosage
- Contraceptives, Oral, Hormonal/adverse effects
- Drug Implants
- Drug-Related Side Effects and Adverse Reactions
- Female
- Germany
- Humans
- Injections, Intramuscular
- Intrauterine Devices, Medicated
- Levonorgestrel
- Papillomavirus Infections/complications
- Pregnancy
- Pregnancy, Unwanted
- Progesterone Congeners/administration & dosage
- Progesterone Congeners/adverse effects
- Risk Factors
- Thromboembolism/chemically induced
- Uterine Cervical Neoplasms/chemically induced
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Affiliation(s)
- Inka Wiegratz
- Klinik für Frauenheilkunde und Geburtshilfe, Schwerpunkt Gynäkologische Endokrinologie und Reproduktionsmedizin, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Germany.
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Jurow R. Emergency Contraception. Contraception 2011. [DOI: 10.1002/9781444342642.ch13] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Gemzell-Danielsson K. Mechanism of action of emergency contraception. Contraception 2010; 82:404-9. [DOI: 10.1016/j.contraception.2010.05.004] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2010] [Accepted: 05/03/2010] [Indexed: 12/30/2022]
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Gemzell-Danielsson K, Meng CX. Emergency contraception: potential role of ulipristal acetate. Int J Womens Health 2010; 2:53-61. [PMID: 21072297 PMCID: PMC2971744 DOI: 10.2147/ijwh.s5865] [Citation(s) in RCA: 33] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2010] [Indexed: 12/30/2022] Open
Abstract
Unintended pregnancy is a global reproductive health problem. Emergency contraception (EC) provides women with a safe means of preventing unwanted pregnancies after having unprotected intercourse. While 1.5 mg of levonorgestrel (LNG) as a single dose or in 2 doses with 12 hours apart is the currently gold standard EC regimen, a single dose of 30 mg ulipristal acetate (UPA) has recently been proposed for EC use up to 120 hours of unprotected intercourse with similar side effect profiles as LNG. The main mechanism of action of both LNG and UPA for EC is delaying or inhibiting ovulation. However, the 'window of effect' for LNG EC seems to be rather narrow, beginning after selection of the dominant follicular and ending when luteinizing hormone peak begins to rise, whereas UPA appears to have a direct inhibitory effect on follicular rupture which allows it to be also effective even when administered shortly before ovulation, a time period when use of LNG is no longer effective. These experimental findings are in line with results from a series of clinical trials conducted recently which demonstrate that UPA seems to have higher EC efficacy compared to LNG. This review summarizes some of the data available on UPA used after unprotected intercourse with the purpose to provide evidence that UPA, a new type of second-generation progesterone receptor modulator, represents a new evolutionary step in EC treatment.
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Affiliation(s)
- Kristina Gemzell-Danielsson
- Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, Stockholm, Sweden
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Katzman DK, Taddeo D. La contraception d'urgence. Paediatr Child Health 2010. [DOI: 10.1093/pch/15.6.368] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
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