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Misoprostol Added to WHO Model List of Essential Medicines for Treatment of Incomplete Abortion and Miscarriage

The World Health Organization announced the inclusion of misoprostol to its Model List of Essential Medicines based on its proven safety and efficacy for the treatment of incomplete abortion and miscarriage. The judgment was made by an expert committee that evaluated available evidence, which includes several guidelines and numerous randomized and comparative clinical trials for this indication.

The proposal was submitted by Gynuity Health Projects based on the following evidence and considerations:

  • Misoprostol is effective for this purpose. More than a dozen randomized or comparative trials have been carried out, the most recent showing that misoprostol has a success rate of about 90-100% for treatment of incomplete abortion and miscarriage.
  • Medical evacuation of the uterus with misoprostol offers an alternative to surgical treatment, which in low-resource settings is often unavailable and may be associated with significant morbidity.
  • Misoprostol is inexpensive and so offers a low-cost but safe and effective means of treating this common obstetrical condition.
  • Misoprostol is safe. More than 600 studies have been published on the use of misoprostol in obstetrics and gynecology that have involved well over 90,000 women.
  • Incomplete abortion contributes disproportionately to maternal morbidity and mortality in much of the developing world.

As described on the WHO website, the Model Essential Medicine List is a guide for the development of national and institutional essential medicine lists. For the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

The Model List also forms the basis for medicines selection in emergency situations. Consequently, the EML guides the responses of humanitarian assistance agencies to country requests for assistance in acute emergency settings. Emergency preparedness is facilitated through standardization of medicine and medical supply needs in emergencies, as outlined in The Interagency Emergency Health Kit, and through guidance on appropriate medicines donations as agreed in the Interagency Guidelines on Drug Donations.

The recommended doses for treatment of incomplete abortion and miscarriage are:

  • A single oral dose of 600 micrograms
  • A single sublingual dose of 400 micrograms

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