The Committee reviewed an application from the Department of Obstetrics and Gynaecology, Medical School, Makarere University, Kampala, Uganda, to include misoprostol for obstetric and gynaecological indications.

The Committee noted that misoprostol, a synthetic prostaglandin E1 analogue, is only approved for the prevention and treatment of non-steroidal anti-inflammatory drug (NSAID)-associated peptic ulcers; a 25mg vaginal tablet has, however, been registered for hospital use in Brazil (18). Nevertheless, misoprostol has been extensively studied and is widely used for a number of obstetric and gynaecological indications, such as pre-induction cervical ripening (3rd trimester), labour induction (3rd trimester, especially at low Bishop scores), evacuation of the uterus after pregnancy failure or for various other medical reasons (2nd trimester) and primary postpartum haemorrhage. It has been shown to be an effective myometrial stimulant of the pregnant uterus, even at the beginning of pregnancy. Thus, it is also an effective abortive agent. Concern about the widespread use of misoprostol as a self-medication has justified its non-approval for marketing in various countries, mainly where abortion is considered illegal. For instance, the use of misoprostol for obstetric indications is not approved by the United States Food and Drug Administration (USFDA).

In view of the limited registration for obstetric and gynaecological indications, the Committee decided that the application to add misoprostol to the Model List could not be considered at this meeting. However, if more widespread registration were to be achieved, a full application - supported by a review of available data on efficacy and safety - would be considered.