DOCSLIB.ORG

Prescribing Patterns of Combined Hormonal Products Containing Cyproterone Acetate, Levonorgestrel and Drospirenone in the UK

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Prescribing Patterns of Combined Hormonal Products Containing Cyproterone Acetate, Levonorgestrel and Drospirenone in the UK RESEARCH J Fam Plann Reprod Health Care: first published as 10.1136/jfprhc-2015-101202 on 20 April 2016. Downloaded from Prescribing patterns of combined hormonal products containing cyproterone acetate, levonorgestrel and drospirenone in the UK 1 Pharmacoepidemiologist, 1,2 3 1 Spanish Centre for Lucía Cea-Soriano, Mari-Ann Wallander, Luis Alberto García Rodríguez Pharmacoepidemiologic Research (CEIFE), Madrid, Spain 2Department of Preventive Medicine and Public Health, Faculty of Medicine, ABSTRACT Complutense University of Background There are limited data to show the Key message points Madrid, Madrid, Spain levels of prescribing of combined oral 3Professor, Department of Public contraceptives (COCs) and other hormonal ▸ Health and Caring Science, There are limited data to show the Uppsala University, Uppsala, products containing estrogen/progestogen levels of prescribing of estrogen/pro- Sweden combinations that may be outside the product gestogen combinations that may be licence. Correspondence to outside the approved product licence. Dr Lucía Cea-Soriano, Aims To determine the diagnosis/indication ▸ In keeping with UK guidelines, the Pharmacoepidemiology, recorded at the time of prescription of level of cyproterone acetate/ethinyles- Spanish Centre for cyproterone acetate/ethinylestradiol (CPA/EE) and tradiol (EE) prescribing for contracep- Pharmacoepidemiologic Research two COCs, levonorgestrel/EE (LNG/EE) and (CEIFE), Almirante 28, tive use was low. Madrid 28004, Spain; drospirenone/EE (DRSP/EE). ▸ The combined oral contraceptives levo- [email protected] Design and setting Retrospective study using a norgestrel/EE and drospirenone/EE were copyright. primary care database, The Health Improvement commonly prescribed for reasons other Received 23 February 2015 Network (THIN). Revised 2 March 2016 than to provide contraception. Accepted 16 March 2016 Methods Women in THIN aged 12–49 years Published Online First prescribed CPA/EE, LNG/EE or DRSP/EE in 2002– 20 April 2016 2010 were identified. Overall use of each product and proportion of new users each year were INTRODUCTION determined. Among new users, database codes In the 50 years since they were first intro- were analysed to infer the reason for prescription. duced, combined oral contraceptives Results The proportion of new users of each (COCs) have remained one of the most product in 2002 and 2010, respectively, were: popular forms of contraception. In 2008/ http://jfprhc.bmj.com/ LNG/EE, 2.03% and 2.40%; CPA/EE, 0.45% and 2009, a UK survey conducted by the 0.27%; and DRSP/EE, 0.27% and 0.56%. Most Office of National Statistics reported that new users prescribed CPA/EE had a record of 25% of women aged 16–49 years were acne (51.0% and 79.2% in 2002 and 2010, using an oral contraceptive pill.1 In respectively) or hirsutism (3.0% and 5.0% in April–June 2010, 1.2 million prescrip- 2002 and 2010, respectively); the proportion of tions for COCs containing 30–40 mg new users with a record only for contraception ethinylestradiol (EE) were dispensed in on October 2, 2021 by guest. Protected decreased from 32.9% in 2002 to 8.6% in England.2 It is well recognised that COCs ▸ http://dx.doi.org/10.1136/ 2010. Among new users prescribed DRSP/EE or may be prescribed for purposes other jfprhc-2016-101585 LNG/EE in 2010, 43.2% and 30.8% of women, than contraception, but prescribing pat- respectively, did not have a record indicating use terns for the non-contraceptive uses of for contraception. COCs are poorly documented. Conclusions Adherence to prescribing Studies have shown that some COCs guidelines for CPA/EE has improved over time. A can be effective in the treatment of acne.3 substantial proportion of women using DRSP/EE Some guidelines also recommend that To cite: Cea-Soriano L, or LNG/EE had records for hormone-responsive Wallander M-A, García these products can be used to manage Rodríguez LA. J Fam Plann conditions only, suggesting that many women menstrual disturbances such as dysmenor- Reprod Health Care were prescribed these therapies for non- rhoea and menorrhagia, although the – 2016;42:247 254. contraceptive use. evidence for effectiveness in these Cea-Soriano L, et al. J Fam Plann Reprod Health Care 2016;42:247–254. doi:10.1136/jfprhc-2015-101202 247 Research J Fam Plann Reprod Health Care: first published as 10.1136/jfprhc-2015-101202 on 20 April 2016. Downloaded from – conditions is based largely on observational studies.4 6 using data from this source.14 The study population In fact, some formulations of COCs, such as levonor- consisted of women in THIN aged 12–49 years gestrel (LNG) and EE (LNG/EE), are also approved between 1 January 2002 and 31 December 2010. To for the treatment of “recognised gynaecological indi- be eligible for inclusion in the study, women were also cations for such oestrogen/progestogen combina- required to have been enrolled with their GP for at tions”.7 In addition, women who do not require least 5 years and to have had a computerised prescrip- contraception may be prescribed hormonal contracep- tion history of at least 1 year. tives solely for these non-contraceptive purposes.8 The use of COCs for the treatment of Ascertainment of user groups hormone-responsive conditions such as acne or hirsut- To ascertain the number of women prescribed each ism, which could be outside the approved licences, treatment in each calendar year during the period – may be common in clinical practice;5 9 however, there 2002–2010 (inclusive), women who met the above are limited data to show how frequently COCs are criteria and who had been prescribed CPA/EE, LNG/ prescribed for such use. EE or DRSP/EE were identified. The date of first pre- In the UK, the combination of cyproterone acetate scription during the study period was defined as the (CPA) and EE (CPA/EE) is indicated for the treatment index date. LNG/EE is available under several brand of moderate-to-severe acne related to androgen sensi- names, in which the dose of EE may be fixed (mono- tivity (that has not responded to oral antibiotic phasic) or variable (phasic). All formulation types therapy) and/or hirsutism in women of reproductive were included. age. This combination is also an effective contracep- tive,10 but marketing approval has not been sought Analysis of new and existing users for this indication. In many cases, acne and hirsutism Each user group was stratified according to previous occur as a result of elevated levels and/or increased prescription contraceptive use. New users were identi- action of circulating androgens, for example in poly- fied as having no record of using any of the study cystic ovary syndrome (PCOS); CPA/EE has the add- treatments before the year of interest, whereas existing itional effect of helping to control the menstrual users had records showing prescription of these pro- irregularities frequently associated with this condi- ducts before the year of interest. New users of each 11 tion. Recently, concerns have been raised in France treatment were further stratified into first-time (naïve) copyright. regarding the risk of venous thromboembolism and users and previous (non-naïve) users. Naïve users had the off-label use of CPA/EE as a contraceptive.12 A no record of previous use of any hormonal contracep- subsequent review by the European Medicines Agency tive before the index date, whereas non-naïve users found that the balance of benefits and risks of treat- had previously received a hormonal contraceptive ment with CPA/EE remained positive, provided that other than the study treatment. several measures were taken to minimise the risk of For each new user, we identified diagnoses or indi- thromboembolism, such as avoiding combination with cations relevant to the prescribing of these treatments other hormonal contraceptives.13 during the earliest (2002) and most recent year The aim of this study was to determine the diagno- (2010) of the study. sis or indication recorded at the time of prescription of CPA/EE and two COCs, using data from a UK Identification of the diagnosis or indication recorded at http://jfprhc.bmj.com/ primary care database, The Health Improvement time of CPA/EE prescription Network (THIN). We examined the patterns of use of We conducted computerised searches of the medical CPA/EE, LNG/EE and drospirenone (DRSP) and EE records of new CPA/EE users, whereby defined search (DRSP/EE; first marketed in the UK in 2002 and only terms were applied individually in a ranked order. licensed for contraception). For each year of the study, Searches were restricted to the 90 days before and we also determined the annual proportion of new after the index date. CPA/EE is approved for the treat- users and the proportion of overall use (i.e. the total ment of acne (with or without seborrhoea) and/or hir- on October 2, 2021 by guest. Protected of new and existing users) among women aged 12– sutism relating to androgen sensitivity in women of 49 years in THIN. reproductive age.16 Most women presenting with symptoms of androgen excess have PCOS,17 which is METHODS also associated with alopecia, menstrual disturbances Study population and anovulation.18 We therefore searched for Read THIN contains anonymised patient data recorded by codes suggestive of: (1) acne, including specific treat- general practitioners (GPs) in 578 participating ments such as tetracycline agents, macrolides, isotreti- primary care practices and includes approximately 6% noin and topical treatments; (2) hirsutism; (3) PCOS; of the UK population.14 In THIN, diagnoses are (4) oligomenorrhoea; (5) anovulation/infertility; (6) recorded using Read codes, and GPs can provide alopecia; and (7) gynaecological disorders. This final further information as free-text entries.15 To date, group included conditions such as dysmenorrhoea, more than 380 research articles have been published menorrhagia, irregular menstruation, premenstrual 248 Cea-Soriano L, et al.
Load more

Recommended publications
  • Ocps) Used in the NM Family Planning Program (FPP
    The following slides are intended to familiarize nurses and clinicians with oral contraceptive pills (OCPs) used in the NM Family Planning Program (FPP). The FPP does not intend for this information to supersede the Family Planning Protocol particularly on the requirement for Public Health Nurses in the Public Health Offices to consult a clinician as stated in the Protocol when in doubt or if it is necessary to switch the client’s OCP type. 1 2 Combined oral contraceptives (COCs) contain two hormones; estrogen and progestin. In general, any combined OCP is good for most women who are eligible to take estrogen according to the CDC U.S. Medical Eligibility Criteria (MEC). Once again, refer to the US MEC chart to find out if OCP is a suitable choice for clients with specific health conditions. To learn a little bit about what each hormone does, the FPP is providing the following summary: Estrogen: provides endometrial stability = menstrual cycle control. A higher estrogen dose increases the venous thromboembolism (VTE) or clot risk but OCP clot risk is still less harmful than the clot risk related to pregnancy and giving birth. Progestin: provides most of the contraceptive effect by ‐Preventing luteinizing hormone (LH) surge /ovulation ‐Thickening the cervical mucus to prevent sperm entry. Two major OCP formations are available. Monophasic: There is only one dose of estrogen and progestin in each active pill in the packet; and Multiphasic: There are varying doses of hormones, particularly progestin in the active pills. 3 Section 3 of the FPP Protocol contains the OCP Substitute Table, which groups OCPs into 6 classes according to the estrogen dosage, the type of progestin and the formulations.
    [Show full text]
  • Comparing the Effects of Combined Oral Contraceptives Containing Progestins with Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis In
    JMIR RESEARCH PROTOCOLS Amiri et al Review Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis in Patients With Polycystic Ovary Syndrome: Systematic Review and Meta-Analysis Mina Amiri1,2, PhD, Postdoc; Fahimeh Ramezani Tehrani2, MD; Fatemeh Nahidi3, PhD; Ali Kabir4, MD, MPH, PhD; Fereidoun Azizi5, MD 1Students Research Committee, School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 2Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 3School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 4Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic Of Iran 5Endocrine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran Corresponding Author: Fahimeh Ramezani Tehrani, MD Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti University of Medical Sciences 24 Parvaneh Yaman Street, Velenjak, PO Box 19395-4763 Tehran, 1985717413 Islamic Republic Of Iran Phone: 98 21 22432500 Email: [email protected] Abstract Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS.
    [Show full text]
  • PMBJP Product.Pdf
    Sr. Drug Generic Name of the Medicine Unit Size MRP Therapeutic Category No. Code Analgesic & Antipyretic / Muscle 1 1 Aceclofenac 100mg and Paracetamol 325 mg Tablet 10's 10's 8.00 relaxants Analgesic & Antipyretic / Muscle 2 2 Aceclofenac Tablets IP 100mg 10's 10's 4.37 relaxants Acetaminophen 325 + Tramadol Hydrochloride 37.5 film Analgesic & Antipyretic / Muscle 3 4 10's 8.00 coated Tablet 10's relaxants Analgesic & Antipyretic / Muscle 4 5 ASPIRIN Tablets IP 150 mg 14's 14's 2.70 relaxants DICLOFENAC 50 mg+ PARACETAMOL 325 mg+ Analgesic & Antipyretic / Muscle 5 6 10's 11.30 CHLORZOXAZONE 500 mg Tablets 10's relaxants Diclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet Analgesic & Antipyretic / Muscle 6 8 10's 12.00 10's relaxants Analgesic & Antipyretic / Muscle 7 9 Diclofenac Sodium (SR) 100 mg Tablet 10's 10's 6.12 relaxants Analgesic & Antipyretic / Muscle 8 10 Diclofenac Sodium 25mg per ml Inj. IP 3 ml 3 ml 2.00 relaxants Analgesic & Antipyretic / Muscle 9 11 Diclofenac Sodium 50 mg Tablet 10's 10's 2.90 relaxants Analgesic & Antipyretic / Muscle 10 12 Etoricoxilb Tablets IP 120mg 10's 10's 33.00 relaxants Analgesic & Antipyretic / Muscle 11 13 Etoricoxilb Tablets IP 90mg 10's 10's 25.00 relaxants Analgesic & Antipyretic / Muscle 12 14 Ibuprofen 400 mg + Paracetamol 325 mg Tablet 10's 15's 5.50 relaxants Analgesic & Antipyretic / Muscle 13 15 Ibuprofen 200 mg film coated Tablet 10's 10's 1.80 relaxants Analgesic & Antipyretic / Muscle 14 16 Ibuprofen 400 mg film coated Tablet 10's 15's 3.50 relaxants Analgesic & Antipyretic
    [Show full text]
  • Desogestrel-Only Pill (Cerazette)
    J Fam Plann Reprod Health Care: first published as 10.1783/147118903101197593 on 1 July 2003. Downloaded from Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit A unit funded by the FFPRHC and supported by the University of Aberdeen and SPCERH to provide guidance on evidence-based practice New Product Review (April 2003) Desogestrel-only Pill (Cerazette) Journal of Family Planning and Reproductive Health Care 2003; 29(3): 162–164 Evidence from a randomised trial has shown that a 75 mg (microgrammes) desogestrel pill inhibits ovulation in 97% of cycles. Thus, on theoretical grounds, we would expect the desogestrel pill to be more effective than existing progestogen- only pills (POPs). However, Pearl indices from clinical trials comparing it to a levonorgestrel POP were not significantly different. Therefore an evidence-based recommendation cannot be made that the desogestrel pill is different from other POPs in terms of efficacy, nor that it is similar to combined oral contraception (COC) in this respect. An evidence-based recommendation can be made that the desogestrel-only pill is similar to other POPs in terms of side effects and acceptability. The desogestrel-only pill is not recommended as an alternative to COC in routine practice, but provides a useful alternative for women who require oestrogen-free contraception. In clinical trials: l Ovulation was inhibited in 97% of cycles at 7 and 12 months after initiation. l The Pearl index was 0.41 per 100 woman-years, which was not significantly different from a levonorgestrel-only pill. However, the trial providing these data was too small to detect a clinically important difference.
    [Show full text]
  • Oral Contraceptives
    ORAL CONTRACEPTIVES STRENGTH DRUG ESTROGEN PROGESTIN (ESTROGEN/PROGESTIN) MONOPHASIC Aviane 28, Lessina, Lutera, Orsythia, Ethinyl estradiol Levonorgestrel 20mcg/0.1mg Sronyx† Beyaz*, YAZ Ethinyl estradiol Drospirenone 20mcg/3mg [Gianvi, Loryna, Vestura]† Brevicon, Modicon Ethinyl estradiol Norethindrone 35mcg/0.5mg [Necon 0.5/35, Nortrel 0.5/35]† Desogen Ethinyl estradiol Desogestrel 30mcg/0.15mg [Apri, Emoquette, Reclipsen, Solia]† Femcon Fe, Ovcon 35 Ethinyl estradiol Norethindrone 35mcg/0.4mg [Balziva, Briellyn, Philith, Vyfemla Zenchent, Zenchent Fe]† Loestrin 21 1/20, Loestrin Fe 1/20, Ethinyl estradiol Norethindrone acetate 20mcg/1mg Loestrin 24 Fe, Minastrin 24 Fe [Gildess Fe 1/20, Junel 1/20, Junel Fe 1/20, Larin 1/20, Larin Fe 1/20, Microgestin 1/20, Microgestin Fe 1/20]† Loestrin 21 1.5/30, Loestrin Fe 1.5/30 Ethinyl estradiol Norethindrone acetate 30mcg/1.5mg [Gildess Fe 1.5/30, Junel 1.5/30, Junel Fe 1.5/30, Microgestin 1.5/30, Microgestin Fe 1.5/30]† Lo/Ovral Ethinyl estradiol Norgestrel 30mcg/0.3mg [Cryselle, Low-Ogestrel]† Lybrel Ethinyl estradiol Levonorgestrel 20mcg/0.09mg [Amethyst]† [Altavera, Levora, Marlissa, Portia]† Ethinyl estradiol Levonorgestrel 30mcg/0.15mg Norinyl 1/35, Ortho-Novum 1/35 Ethinyl estradiol Norethindrone 35mcg/1mg [Alyacen 1/35, Cyclafem 1/35, Dasetta 1/35, Necon 1/35, Nortrel 1/35]† Necon 1/50, Norinyl 1/50 Mestranol Norethindrone 50mcg/1mg Ogestrel 0.5/50† Ethinyl estradiol Norgestrel 50mcg/0.5mg Ortho-Cyclen Ethinyl estradiol Norgestimate 35mcg/0.25mg [MonoNessa, Previfem, Sprintec]† Ovcon
    [Show full text]
  • World Health Organization Model List of Essential Medicines, 21St List, 2019
    World Health Organizatio n Model List of Essential Medicines 21st List 2019 World Health Organizatio n Model List of Essential Medicines 21st List 2019 WHO/MVP/EMP/IAU/2019.06 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. World Health Organization Model List of Essential Medicines, 21st List, 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.
    [Show full text]
  • EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
    EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of
    [Show full text]
  • Molecular and Preclinical Pharmacology of Nonsteroidal Androgen Receptor Ligands
    Molecular and Preclinical Pharmacology of Nonsteroidal Androgen Receptor Ligands Dissertation Presented in Partial Fulfillment of the Requirements for the Degree Doctor of Philosophy in the Graduate School of The Ohio State University By Amanda Jones, M.S. Graduate Program in Pharmacy The Ohio State University 2010 Dissertation Committee: James T. Dalton, Advisor Thomas D. Schmittgen William L. Hayton Robert W. Brueggemeier Copyright by Amanda Jones 2010 Abstract The androgen receptor (AR) is critical for the growth and development of secondary sexual organs, muscle, bone and other tissues, making it an excellent therapeutic target. Ubiquitous expression of AR impedes the ability of endogenous steroids to function tissue selectively. In addition to the lack of tissue selectivity, clinical use of testosterone is limited due to poor bioavailability and pharmacokinetic problems. Our lab, in the last decade, discovered and developed tissue selective AR modulators (SARMs) that spare androgenic effects in secondary sexual organs, but demonstrate potential to treat muscle wasting diseases. This work reveals the discovery of next generation SARMs to treat prostate cancer and mechanistically characterize a prospective SARM in muscle and central nervous system (CNS). Prostate cancer relies on the AR for its growth, making it the primary therapeutic target in this disease. However, prolonged inhibition, with commercially available AR antagonists, leads to the development of mutations in its ligand binding domain resulting in resistance. Utilizing the crystal structure of AR-wild-type and AR-W741L mutant, we synthesized a series of AR pan- antagonists (that inhibit both wild-type and mutant ARs). Structure activity relationship studies indicate that sulfonyl and amine linkages of the aryl propionamide pharmacophore are important for the antagonist activity.
    [Show full text]
  • Oral Contraceptive Identification Chart
    Oral Contraceptive Identification Chart View the full Prescribing Information by clicking on the Teva Generic product name. Brand Teva Generic NDC Strength(s) Size Alesse®* Aviane® (levonorgestrel and ethinyl estradiol tablets, USP) 00555-9045-58 0.1 mg/0.02 mg 6 x 28 Blister Packs 0.1 mg/0.025 mg; 0.125 Velivet® (desogestrel and ethinyl estradiol tablets, USP - triphasic Cyclessa® 00555-9051-67 mg/0.025 mg; 0.15 3 x 28 Blister Packs regimen) mg/0.025 mg Kelnor® 1/35 (ethynodiol diacetate and ethinyl estradiol tablets, 00555-9064-58 1 mg/35 mcg 6 x 28 Blister Packs USP) Demulen®* Kelnor® 1/50 (ethynodiol diacetate and ethinyl estradiol tablets 00093-8073-16 1 mg/50 mcg 6 x 28 Blister Packs USP) 1 mg/20 mcg; Tri-Legest® Fe 28 (norethindrone acetate and ethinyl estradiol Estrostep® Fe 00555-9032-70 1 mg/30 mcg; 5 x 28 Blister Packs tablets, USP and ferrous fumarate tablets†) 1 mg/35 mcg Layolis® Fe (norethindrone and ethinyl estradiol chewable tablets Generess® Fe 52544-0064-31 0.8 mg/25 mcg 3 x 28 Blister Packs and ferrous fumarate chewable tablets†)‡ Levlite®* Lessina® (levonorgestrel and ethinyl estradiol tablets, USP) 00555-9014-67 0.1 mg/0.02 mg 3 x 28 Blister Packs Lo/Ovral®* Cryselle® (norgestrel and ethinyl estradiol tablets, USP) 00555-9049-58 0.3 mg/0.03 mg 6 x 28 Blister Packs Junel® 1/20 (norethindrone acetate and ethinyl estradiol tablets, 00555-9025-42 1 mg/20 mcg 3 x 21 Blister Packs USP) Loestrin® 21 Junel® 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, 00555-9027-42 1.5 mg/30 mcg 3 x 21 Blister Packs USP)
    [Show full text]
  • Dienogest/Ethinylestradiol: Slightly Higher Relative Risk of Venous Thromboembolism
    VOLUME 23 NUMBER 5 MAY 2019 Dienogest/ethinylestradiol: Slightly higher relative risk of venous thromboembolism Quick Read The benefits from the use of combined hormonal contraceptives (CHCs) remain higher than the attending risk of serious collateral effects. However, prescription decisions should take the risk profile of each individual woman into account. Users of any CHC have an associated increase in the risk of venous thromboembolism (VTE) when compared with non-users, especially during the first year of exposure. Risk varies slightly among contraceptives but those with the lowest risk contain levonorgestrel, norethisterone or norgestimate for a progestagen. Pregnancy and puerperium are meanwhile associated with the greatest risk. The combination of ethynilestradiol with the progestagen dienogest is indicated in oral contraception. The underlying mechanism of action results from the interaction of various factors, namely inhibition of ovulation and changes in cervical mucus. Whenever oral contraceptives are prescribed, each individual woman’s risk factors need to be borne in mind and especially so the risk of venous thromboembolism (VTE – deep venous thrombosis, pulmonary embolism). The information concerning Valette® (a CHC marketed in Portugal) has recently been reviewed at European level in what regards the risk of VTE in women taking dienogest/ethynilestradiol (DNG/EE) versus users of other CHCs containing levonorgestrel/ethynilestradiol (LNG/EE). The assessment looked at a metaanalysis of four large, controlled, prospective observational studies following a series of cohorts: the LASS (Long-term active surveillance study for oral contraceptives), INAS-OC (International active surveillance study of women taking oral contraceptives), TASC (Transatlantic active surveillance on cardiovascular safety of Nuvaring (etonogestrel/ethinylestradiol vaginal ring) and INAS-SCORE (International active surveillance study – safety of contraceptives: role of estrogens) studies.
    [Show full text]
  • Association of Hormonal Contraception with Depression
    Supplementary Online Content Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of hormonal contraception with depression. JAMA Psychiatry. Published online September 28, 2016. doi:10.1001/jamapsychiatry.2016.2387 eFigure 1. Women and Person-years Fulfilling Various Inclusion and Exclusion Criteria eFigure 2. Use of Different Types of Hormonal Contraceptives According to Age in Denmark 2013 eFigure 3. Use of Antidepressants in Users of Different Types of Hormonal Contraceptives Among Parous Women 15-34 Years Old eTable 1. Included Groups of Hormonal Contraceptives and Corresponding Anatomic Therapeutic Chemical (ATC) Codes eTable 2. Anatomic Therapeutic Chemical (ATC) Codes of the Included Antidepressants eTable 3. Relative Risk of First Use of Antidepressants in Users of Different Types of Hormonal Contraceptives Compared With Users of Combined Oral Contraceptives With Levonorgestrel eTable 4. Relative Risk of First Use of Antidepressants Compared With Never-Users of Hormonal Contraceptives eTable 5. Relative Risk of First Use of Antidepressants in Starters of Different Types of Hormonal Contraceptives: Adolescents 15-19 Years of Age and Women 20-30 Years of Age eTable 6. Overview of Articles on Hormonal Contraception and Depression eDiscussion. Comparison With Prior Studies This supplementary material has been provided by the authors to give readers additional information about their work. © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 eFigure 1. Women and Person-years Fulfilling Various Inclusion and Exclusion Criteria 1,359,499 all women living in Denmark 15–34 years 2000–2013 identified 243,012 Immigrated after 1995 1,887 Cancer 1,686 VTE-event 16,350 IVF-treatment 4,701 Psychiatric diagnoses 4,203 Depression diagnoses 27,063 Antidepressant use 1,061,997 women inclued in the study 6,832,938 person-years observation time after censoring 3,791,343 person-years of exposed to hormonal contraception © 2016 American Medical Association.
    [Show full text]
  • Assessment Report Cyproterone Acetate/Ethinylestradiol (2 Mg/0.035 Mg) Containing Medicinal Products
    24 May 2013 EMA/339116/2013 Assessment report cyproterone acetate/ethinylestradiol (2 mg/0.035 mg) containing medicinal products Procedure under Article 107i of Directive 2001/83/EC Procedure number: EMEA/H/A-107i/1357 Assessment Report as adopted by the PRAC with all information of a confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 3 2. Scientific discussion ................................................................................ 3 2.1. Clinical aspects .................................................................................................... 4 2.1.1. Clinical safety .................................................................................................... 4 2.1.2. Clinical efficacy ............................................................................................... 22 2.2. Risk minimisation activities .................................................................................. 29 2.3. Product information ............................................................................................ 31 2.4. Benefit-risk assessment .....................................................................................
    [Show full text]