Although misoprostol (Cytotec), an E1 prostaglandin, is labeled and registered only for the treatment and prevention of gastric ulcers, mounting evidence suggests widespread use in Brazil for a host reproductive health indications. Women in Brazil have been using it covertly to induce abortion for over a decade. Obstetricians and gynecologists in Brazil have also discovered misoprostol's potential for a wide range of indications including labor induction, post-partum hemorrhage, intra-uterine fetal demise, cervical softening, missed and incomplete abortion as well as first and second trimester abortion induction. Since there are no labeled regimens for any of these indications, however, providers have relied on the medical literature and colleagues, as well as their own experiences, to develop their own regimens. Yet, surprisingly little is known about the use of misoprostol in clinical practice. To investigate its clinical use, we conducted a survey of 223 gynecologists and obstetricians throughout Brazil from February 1999 to May 2000, using a "snowball" technique to identify providers. We found that most providers (more than 70%) used misoprostol to treat missed abortion and intra-uterine fetal demise. In contrast, only 7% of providers interviewed used it for prevention of post-partum hemorrhage. There was considerable variation in the dose, route of administration, number of doses, and time interval between doses for virtually every indication. The widespread appeal of misoprostol and its myriad off-label uses in reproductive health care services raise critical policy questions with which professional organizations, women's health groups, drug regulatory agencies, and the pharmaceutical industry need to contend.
Learning Objectives: After this presentation, participants will have a clear sense of the widespread off-label use of misoprostol for reproductive health indications and a better understanding of the variety of regimens used for labor induction, post-partum hemorrhage, cervical softening, IUFD, missed and incomplete abortion, as well as abortion induction in the first and second trimester. Participants should be able to list several of the reproductive health indications for which misoprostol is currently used. They should also be able to identify not only the advantages but also the potential risks of using misoprostol off-label. This information should help them develop their own clinical guidelines for the safe use of misoprostol in their practices.
Keywords: Reproductive Health, Access and Services
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Searle
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.