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International Journal of Gynecology and Obstetrics (2007) 99, S156–S159 a v a i l a b l e a t w w w. s c i e n c e d i r e c t . c o m w w w. e l s e v i e r. c o m / l o c a t e / i j g o Although misoprostol is generally not registered for repro- experiences have been described in other Latin American ductive health use, it is widely used by gynecologists and obstetricians. In a survey on the use of misoprostol con- Misoprostol's undisputed ability to bring on uterine ducted in three contrasting countries (Brazil, Jamaica and contractions led to it being evaluated as a means of inducing the USA), 61% of obstetricians and gynecologists stated that abortion or labor with a dead or live fetus, or they used it to evacuate the uterus after intrauterine fetal to interrupt pregnancy Its potential was especially death, 57% used it for missed abortions, and 46% to induce promising in the developing world where maternal mortality labor Its popularity may be accounted for by the fact that is high and where an effective, low-cost and stable prosta- it is as effective as the best available prostaglandin at soft- glandin is urgently needed. The benefits of misoprostol in ening the cervix and producing contractions of the uterus, settings with few resources have since been widely demon- while at the same time being low-cost and heat-stable.
strated. It has been possible to reduce failed inductions and The absence of registration for its obstetrical and gyne- the proportion of cesarean sections and it has cological applications is an important problem. The pharma- facilitated the difficult challenge of evacuating a dead fetus ceutical industry is normally responsible for informing during the second trimester of pregnancy, substituting physicians about drugs' indications, effectiveness, correct methods that carry a high risk of morbidity and mortality dosages, route of administration, dosage interval, contra- It has also proved its capacity to prevent postpartum indications, precautions, side-effects and management of hemorrhage in situations where oxytocin is not available or complications. However, as misoprostol is generally not re- may lose effectiveness due to high ambient temperatures gistered for reproductive health indications, the industry has and there is also now evidence to correlate the neither provided this information for physicians nor pack- increase in its use with the reduction of morbidity and aged the drug in appropriate dosages. The result is that this mortality associated with abortion in countries with restric- drug is used in many different ways according to informal local protocols. While this may not be a serious problem in In spite of all these advantages, misoprostol has not been early pregnancy, the use of too high a dose in late pregnancy approved for use in gynecology or obstetrics in most can have serious consequences. In induction of labor, for countries. However, there are signs that health regulators example, too high a dose of misoprostol may cause uterine are embracing the use of misoprostol. In 2003, the use of hyperstimulation and rupture of the uterus, thus jeopardiz- misoprostol in combination with mifepristone was approved ing the life of the mother and of the fetus by the United States Food and Drug Administration for the Misoprostol is an analogue of prostaglandin E1 (PG E1) induction of abortion and misoprostol has been added which was registered in many countries during the second to the World Health Organization (WHO) Model List of half of the 1980s under the proprietary name Cytotec Essential Drugs for the induction of labor and abortion (Pharmacia), for the treatment of peptic ulcers, particularly In 2006, the government of Nigeria registered misoprostol for those caused by non-steroidal anti-inflammatory drugs the prevention and treatment of postpartum hemorrhage, Its use for this purpose is contraindicated for pregnant and a national distribution program is underway in Ethiopia women as it may cause uterine contractions and miscarriage.
In Brazil, as in many other countries where abortion is exclusive rights to misoprostol ran out in 2005, and a number illegal, employees of retail pharmacies are accustomed to of generic alternatives to Cytotec are now being produced.
selling a wide range of drugs to “bring on periods”. In the Misoprostol 200 μg tablets are now produced in France, 1980s they realized that the uterine “side-effect” of Cytotec China, Brazil and Taiwan, and 25 μg vaginal pessaries are made it a highly effective drug for “bringing on periods” in cases of delayed menses. The knowledge that misoprostol was very effective at causing abortions spread rapidly and, The absence of clear guidance relating to use of by the end of the 1980s, a high proportion of clandestine misoprostol in gynecology and obstetrics has meant that abortions in Brazil were induced by misoprostol . Similar physicians and their patients run the risk of inappropriate 0020-7292/$ - see front matter 2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
use, with potentially severe consequences for both woman ogy and obstetrics in this supplement is to enable practi- and fetus. It also places the attending physicians at risk of tioners to use the drug safely outside the approved litigation as, in the absence of a license for use in pregnancy, indications, while being well informed about the product, legal liability rests with the prescriber.
to base its use on firm scientific rationale and on soundmedical evidence. Guidelines for misoprostol use in repro- ductive health are available in South America and on theinternet (but it is hoped that this supplement will make knowledge about optimal misoprostoldosages more widely available.
Use of drugs for indications other than those approved (‘off-label’ use) is common practice in obstetrics . In a recentstudy of 17,000 consecutive antenatal prescriptions in a large UK government hospital, only 1% of drugs were unlicensedHowever, 75% of all prescriptions were ‘off-label’, most This supplement is designed to provide guidance to help our of which would be considered safe for use in pregnancy. They fellow gynecologists and obstetricians to take decisions on included betamethasone (for the prevention of respiratory treatment for a number of specific conditions. This requires distress syndrome in premature neonates), erythromycin an evaluation of the evidence and a weighing up of the (for the prevention of chorioamnionitis after ruptured mem- potential risks and benefits of the drug's use in each specific branes) and magnesium sulfate (for eclampsia). Only 10% of the drugs prescribed were considered high risk. ‘Off-label’ Misoprostol has a large number of potential uses. In this therapy is also accepted, for example, by the United States supplement, a team of experts has assessed the existing Food and Drug Administration, which stated, “Good medical evidence and has suggested an optimal dose and route. In practice and the best interests of the patient require that clinical practice, however, it is for each physician to decide physicians use legally available drugs … according to their how best to apply it in his or her own practice, depending on best knowledge and judgment. If physicians use a product the circumstances of each individual case for an indication not in the approved labeling, they have the In an effort to include the different uses of misoprostol in responsibility to be well informed about the product, to gynecology and obstetrics, this supplement includes the fol- base its use on firm scientific rationale and on sound medical lowing articles: “pharmacokinetics and basic science”; “cer- evidence, and to maintain records of the product's use and vical priming”; “induced abortion in 1st trimester”; “induced abortion in 2nd trimester”; “incomplete abortion”; Our objective in publishing the essential points of our “missed abortion”; “early embryonic loss”; “intrauterine existing knowledge about the use of misoprostol in gynecol- fetal death”; “induction of labor with a live fetus”, and Misoprostol dosages for reproductive health Ideally used 48 h after mifepristone 200 mg Leave to work for 1–2 weeks (unless heavy Use 200 μg only in women with cesarean scar.
Ideally used 48 h after mifepristone 200 mg Reduce doses in women with previous cesarean 25 μg vaginally 4-hrly OR 50 μg orally Do not use if previous cesarean section Not as effective as oxytocin or ergometrine.
Exclude second twin before administration.
Do not repeat within 2 h Limited evidence for benefit — use conventionaloxytocics first 400 μg vaginally 3 h before procedure Use for insertion of intrauterine device, surgical termination of pregnancy, dilatation andcurettage, hysteroscopy Wallchart with summary of misoprostol dosages for reproductive health indications (stat = single dose taken immediately, PPH = postpartumhemorrhage) International Journal of Gynecology and Obstetrics 2007 “prevention and treatment of postpartum hemorrhage”. A [9] Costa SH, Vessey MP. Misoprostol and illegal abortion in Rio de summary table of the recommended dosages in each chapter Janeiro, Brazil. Lancet May 15 1993;341(8855):1258–61.
[10] Miller S, Lehman T, Campbell M, Hemmerling A, Anderson SB, Some concepts are repeated in all articles, such as Rodriguez H, et al. Misoprostol and declining abortion-relatedmorbidity in Santo Domingo, Dominican Republics: a temporal contraindications for the use of misoprostol. This is done so association. BJOG 2005;112:1291–6.
that each article can be consulted independently from the [11] Mariani Neto C, Leão EJ, Barreto MCP, Kenj G, Aquino MM, Tuffi others. The exception is drug pharmacology, which called for VHB. Uso do misoprostol para indução do parto com feto morto.
a whole separate chapter. For the sake of brevity, we give no specific guidance on counseling before the drug's use. How- [12] Bugalho A, Bique C, Machungo F, Faundes A. Induction of labor ever, it should be taken as read that all patients will benefit with intravaginal misoprostol in intrauterine fetal death. Am J from receiving information about the likely course of the Obstet Gynecol Aug 1994;171(2):538–41.
treatment and possible side-effects.
[13] Margulies M, Campos Perez G, Voto LS. Misoprostol to induce No attempt has been made to classify the strength of labor [letter]. Lancet 1992;339:364.
the evidence available for each indication. However, all [14] Grimes DA. Mifepristone (RU 486) for induced abortion.
Womens Health Issues 1993;3(3):171–5.
statements about the use of misoprostol in this supple- [15] Bugalho A, Bique C, Machungo F, Faundes A. Low-dose vaginal ment have been agreed by the authors and submitted to misoprostol for induction of labor with a live fetus. Int J the scrutiny of other external experts. The papers on Gynecol Obstet May 1995;49(2):149–55.
each indication were written by misoprostol experts [16] Reichler A, Romem Y, Divon MY. Induction of labor. Curr Opin brought together by the UNDP/UNFPA/WHO/World Bank Obstet Gynecol Dec 1995;7(6):432–6.
Special Programme of Research, Development and [17] Bauer T, Brown D, Chai L. Vaginal misoprostol for term labor Research Training in Human Reproduction (HRP) for a induction. Ann Pharmacother 1997;31:1391–3.
meeting in Bellagio, Italy in February 2007. Funding for [18] el Refaey H, Jauniaux E. Methods of induction of labour. Curr the meeting was provided from various sources including Opin Obstet Gynecol Dec 1997;9(6):375–8.
HRP, the Rockefeller Foundation, Gynuity Health Projects [19] Bugalho A, Bique C, Almeida L, Faúndes A. The effectiveness of intravaginal misoprostol (Cytotec) in inducing abortion after eleven weeks of pregnancy. Stud Fam Plann 1993;24(5): We are aware that some of the recommended doses, routes of administrations and intervals between doses may [20] Murray S, Muse K. Mifepristone and first trimester abortion. Clin change in the future, when further evidence becomes avail- Obstet Gynecol Jun 1996;39(2):474–85.
able. This is just part of medical history. The combined [21] Scheepers HC, van Erp EJ, van den Bergh AS. Use of misoprostol contraceptive pills used today are considerably better than in first and second trimester abortion: a review. Obstet Gynecol the original pills of the 1950s, but millions of women bene- fited from those early “imperfect” pills.
[22] Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of The intention of this publication is to make accessible to pregnancy. N Engl J Med Mar 30 2000;342(13):946–56.
our colleagues throughout the world a synthesis of the [23] Has R, Batukan C, Ermis H, Cevher E, Araman A, Kilic G, et al.
Comparison of 25 and 50 ug vaginally administered misoprostol current knowledge on the use of this drug. It is hoped that for preinduction cervical ripening and labor induction. Gynecol this will avoid dangerous misuse and improve practice with a view to reducing maternal morbidity and mortality.
[24] Perry KG, Larmon JE, May WL, Robinette LG, Martin RW.
Cervical ripening: a randomized comparison between intrava- ginal misoprostol and an intracervical balloon catheter com-bined with intravaginal dinoprostone. Am J Obstet Gynecol1998;178:1333–40.
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[28] Golberg AB, Greenberg MB, Darney PD. Misoprostol and [5] Garris RE, Kirkwood CF. Misoprostol: a prostaglandin E1 pregnancy. N Engl J Med 2001;344:38–47.
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[29] Neilson JP, Hickey M, Vazquez J. Medical treatment for early [6] Walt RP. Misoprostol for the treatment of peptic ulcer and fetal death (less than 24 weeks). Cochrane Database Syst Rev antiinflammatory-drug-induced gastroduodenal ulceration.
N Engl J Med Nov 26 1992;327(22):1575–80.
[7] Barradell LB, Whittington R, Benfield P. Misoprostol: pharma- [30] Clark W, Shannon C, Winikoff B. Misoprostol for uterine coeconomics of its use as prophylaxis against gastroduodenal evacuation in induced abortion and pregnancy failure. Expert damage induced by nonsteroidal anti-inflammatory drugs.
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[31] Derman RJ, Kodkany BS, Goudar SS, et al. Oral misoprostol in [8] Barbosa RM, Arilha M. The Brazilian experience with Cytotec.
preventing postpartum haemorrhage in resource-poor commu- nities: a randomized controlled trial. Lancet 2006;368:1248–53.
[32] Hoj L, Cardosa P, Nielsen BB, Hvidman L, Nielsen J, Aaby P.
[39] McManus A, Herring C, Weeks A. What proportion of antenatal Effect of sublingual misoprostol on severe postpartum haemor- prescriptions are licensed at Liverpool Women's’ Hospital? Data rhage in a primary health centre in Guinea–Bissau: randomized presented at British International Congress of Obstetrics and double blind clinical trial. BMJ 2005;331:723.
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