J Song1. 1. Department of Obstetrics and Gynecology, Wagga Wagga Hospital, NSW, Australia.
Abstract
UNLABELLED: Misoprostol is prostaglandin E1 analogous and marketed for prevention and treatment of peptic ulcer disease. However, it has been used widely in obstetrics and gynecology practice because of its effectiveness, low cost, stability in light and hot climate conditions, and ease of administration compared with its licensed counterparts--dinoprostone and gemeprost. A large number of studies have shown that misoprostol is effective in first and second trimester abortion, late pregnancy labor induction, and third stage of labor management (misoprostol has not been approved by the U.S. Food and Drug Administration for these indications). Because misoprostol is not registered for such use, it has not undergone the extensive testing for appropriate dosage and safety required for registration. Serious complications such as teratogenesis after failed abortions and uterine rupture during second trimester abortions and third trimester labor induction have been reported as the result of increasingly wide use of misoprostol in obstetric and gynecology practice. There is an urgent need to evaluate all the available data and organize a large randomized trial to determine the safety of its use in obstetric and gynecology practice. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader will be able to identify the various uses of misoprostol, to describe the potential complications of misoprostol use and its teratogenic effects, to compare the various routes of administration, and to define the appropriate dose.
UNLABELLED: Misoprostol is prostaglandin E1 analogous and marketed for prevention and treatment of peptic ulcer disease. However, it has been used widely in obstetrics and gynecology practice because of its effectiveness, low cost, stability in light and hot climate conditions, and ease of administration compared with its licensed counterparts--dinoprostone and gemeprost. A large number of studies have shown that misoprostol is effective in first and second trimester abortion, late pregnancy labor induction, and third stage of labor management (misoprostol has not been approved by the U.S. Food and Drug Administration for these indications). Because misoprostol is not registered for such use, it has not undergone the extensive testing for appropriate dosage and safety required for registration. Serious complications such as teratogenesis after failed abortions and uterine rupture during second trimester abortions and third trimester labor induction have been reported as the result of increasingly wide use of misoprostol in obstetric and gynecology practice. There is an urgent need to evaluate all the available data and organize a large randomized trial to determine the safety of its use in obstetric and gynecology practice. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader will be able to identify the various uses of misoprostol, to describe the potential complications of misoprostol use and its teratogenic effects, to compare the various routes of administration, and to define the appropriate dose.