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Misoprostol recommended dosage guidelines updated by FIGO 2012

FIGO have recently produced new guidelines for the recommended dosages of misoprostol based on updated guidelines for induction of labour by WHO and updated guidelines for the prevention and treatment of post-partum haemorrhage by FIGO.

Also included in the updated misoprostol recommended dosage guidelines are the retained guidelines from Bellagio group on missed abortion and intrauterine foetal death in the 1st and 2nd trimester. 

Studies published investigating Misoprostol for the treatment of PPH

Three large Randomised Control Trials were carried out by Gynuity Health Projects and The World Health Organisation. They were published in The Lancet in 2010, much expanding a rather lacking evidence base about Misoprostol's efficacy in treating PPH.

The three trials involved more than 40 000 women from 8 different countries. The trials concluded that Misoprostol was less effective than oxytocin and was of no benefit as an adjunct treatment to oxytocin. However, all three trials also highlighted that misoprostol was a safe and effective alternative in settings where injectable uterotonics are not available.

Read more about the trials

Studies published investigating Misoprostol's role in PPH prevention in community settings

As the growing evidence-base continues to conclude that Misoprostol is an effective and safe alternative in settings where oxytocin use is not viable, more studies are being published that investigate the efficacy and feasibility of misoprostol distribution in communities for PPH prevention; both for self-administration by women and administration by non-skilled health personnel.

Read more about the studies.

Venture Strategies Innovations is an NGO that promotes women's health by providing access to appropriate technologies. They have had much involvement in promoting the use of Misoprostol and have done several pilot projects involving the distribution of Misoprostol in community settings; they have used the outcomes of these to encourage the inclusion of Misoprostol for PPH prevention in the policy of individual countries. Click here to see a full list of their Misoprostol related progamme reports.

The World Health Organisation list of Essential Medicines - Misoprostol added for PPH prevention

In 2011 the WHO list of Essential Medicines was updated and, after a successful application by Gynuity Health Projects and Venture Strategies Innovations, Misoprostol was included in the list for the prevention of PPH. To read the evidence and applications for it's inclusion click here.

It had previously only been included for labour induction and medical abortion indications. This decision has been made by an expert committee who have evaluated the evidence for Misoprostol and decided it is a safe and effective method of PPH prevention.

The list is supposed to consist of drugs that should be made accessible to populations in terms of cost and distribution. To read more about the list and it's purpose click here. Misoprostol's inclusion for PPH prevention is an important as the WHO list is a highly influential factor in determining individual countries health policies.

Russian guidelines added to the site                           

The FIGO dosage chart has now been translated into Russian and is available here.

New Guide to Diluting Misoprostol added

A new pictorial guide to the dilution of Misoprostol has been added to the site. It outlines how to safely make up a 200ml batch of a 1 microgram per ml solution of misoprostol for oral administration, and can be found here.

Misoprostol guidelines adopted by FIGO

The misoprostol dosage guidelines which appear on this site have recently been adopted by the International Federation of Gynecology and Obstetrics (FIGO). Although the guidelines had originally been commissioned by WHO, they made a strategic decision in 2008 not to produce specific dosage guidelines but instead to produce guidelines based on each specific indication. However, FIGO have now taken over the guidelines, and they disseminated them widely at the FIGO international conference in Cape Town in 2009.

Misoprostol added to WHO Model list of Essential Medicines for the treatment of incomplete miscarriage and abortion

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 full list is available here

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.

Misoprostol approved in Uganda, Nigeria, Ethiopia, Somaliland and Mozambique for PPH

The Californian based non-profit making organisation Venture Strategies Innovations reports that misoprostol is being distributed throughout hospitals and clinics in Uganda, Nigeria and Ethiopia for the prevention and treatment of post-partum hemorrhage, the leading cause of maternal death.

Venture Strategies worked with UC Berkeley's School of Public Health to help Nigerians obtain the world's first regulatory approval of misoprostol for controlling postpartum hemorrhage. They obtained the lowest prices in the world from high quality manufacturers in China and Egypt and are helping to facilitate the type of South-South trade established in Nigeria with other countries in Africa and the Middle East, at their request. The approved dosages are 600 microgrammes orally for prevention and 1000 microgrammes rectally for treatment. More details are available here from the Venture Strategies website.

Misoprostol effective for preventing postpartum haemorrhage (PPH)

A study by Richard Derman and colleagues conducted in rural India (Lancet 2006; 368:1248-1253) has revealed the efficacy of misoprostol tablets for prevention of PPH. Over 1600 low risk women were randomised to receive oral misoprostol (600 microgrammes) or placebo at the time of delivery. Blood was collected for the first hour post-partum. In the misoprostol group, the risk of PPH (>500mls) was halved, and the risk of severe PPH was reduced by 80%. The authors conclude that "oral misoprostol is safe, effective, and inexpensive ($1·00 per 600 μg dose) for women giving birth in low-resource settings". Click here for the free original article from the Lancet.

In a Lancet letter on this research, Andrew Weeks demonstrates why misoprostol is effective for women with PPH, but has little effect on normal bleeding (in contrast to oxytocin). Oral misoprostol is absorbed more slowly than intramuscular oxytocin, and by the time it reaches its peak at 20 minutes the third stage is over for most women (see figure below). Thus, the more prolonged the bleeding (i.e. the PPH), the more effective misoprostol is.

 

 

 

Pfizer stops selling Cyotec in Germany

In January 2006, Pfizer has stopped selling Cytotec in Germany without prior notice. The official reason given by the company is that misoprostol is an outdated treatment regimen and not “state of the art” anymore. Also the company stated that this decision is limited to Germany.

However it is known that Pfizer and formerly Searle have been unhappy with the use of Cytotec in OB/Gyn. And it is left to speculation how much this withdrawal is a way to get rid of the product and whether or not other countries will follow. Luckily the drug remains available in Germany, as there are several import licenses for Cytotec, for example the company Kohl Pharma in Merzig/Saar: www.kohlpharma.com

Also Arthotec (a combination of misoprostol and diclofenac) remains on the market.