E-DRUG: Misoprostol added to WHO EML for incomplete abortion & miscarriage
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[Here a first press release about the addition of misoprostol for
incomplete abortion. Cross-posted from druginfo with thanks. WB]
April 29, 2009
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
Contact empinfo@who.int or pubinfo@gynuity.org for more detailed
information.
Melanie Peña
Senior Program Associate
15 East 26th St, Suite 801
New York, NY 10010, USA
Tel. 1.212.448.1230/ Fax 1.212.448.1260
Skype: melaniepena
www.gynuity.org