WHO Drug Information Vol. 19, No. 3, 2005
(2005; 72 pages) View the PDF document
Table of Contents
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsSafety and Efficacy Issues
Open this folder and view contentsHerbal Medicines
Open this folder and view contentsRegulatory Action and News
Close this folderEssential Medicines
Close this folderHighlights of the 14th Model List of Essential Medicines
View the documentMethadone and buprenorphine
View the documentMifepristone with misoprostol
View the documentWHO Model List of Essential Medicines
Open this folder and view contentsAccess to Medicines
Open this folder and view contentsThe International Pharmacopoeia
View the documentRecommended International Nonproprietary Names: List 54
 

Mifepristone with misoprostol

A review of 39 trials (1) indicated that administration of mifepristone followed by misoprostol within 36 to 48 hours is effective in inducing medical abortion of up to 9-weeks of pregnancy. Major complications seem to be rare, the most common complication being blood transfusion (about 0.2%). It was reported that the side-effects were mainly due to prostaglandins and involved nausea, vomiting, and diarrhoea. In comparison to surgical abortion, (2) the risks of bleeding, abdominal pain, fever and dizziness in the medical abortion population were higher than those in the surgical abortion population. In addition, the duration of bleeding caused by medical abortion was longer than that caused by surgical abortion.

Mifepristone followed by misoprostol for medical abortion in the first nine weeks of pregnancy has been registered in the following countries in Europe: Austria, Belgium, Finland, France, Germany, Greece, Luxembourg, the Netherlands, Norway, Romania, Spain, Sweden, Switzerland and the UK. The regimen has also been registered in Azerbaijan, Georgia, India, Israel, New Zealand, the People's Republic of China, the Russian Federation, South Africa, Tunisia, Ukraine, the USA, Uzbekistan and Viet Nam.

The Committee recommended that mifepristone and misoprostol be included on the complementary list of the Model List section 22 for medical abortion within nine weeks of pregnancy, and that the following footnote be added: "Requires close medical supervision". In reviewing the recommendation relating to this combination of products, the Director-General of WHO has added a note adjacent to the combination in the Model List stating "Where permitted under national law and where culturally acceptable".

References

1. Kulier R, Gllmezoglu AM, Hofmeyr GJ, Cheng LN, Campana A. Medical methods for first trimester abortion. The Cochrane Database of Systematic Reviews 2004, Issue 2 (http://www.cochrane.org/cochrane/revabstr/AB002855.htm)

2. Zou Y, Li YP, Lei ZW, Lu L, Jiang S, Li Q. Side effect of mifepristone in combination with misoprostol for medical abortion. Zhonghua Fu Chan Ke Za Zhi 2004; 39: 39-42.

3. 14th Expert Committee on the Selection and Use of Essential Medicines Geneva, 7-11 March 2005, unedited report of the Committee is at: http://www.who.int/medicines/library/general/1-ReportFinal-unedited_010705.pdf

4. WHO Model List of Essential Medicines, in Arabic, Chinese, English, French, Spanish and Russian. Available at: http://www.who.int/medicines/organization/par/edl/eml/shtml

Additions and deletions to the WHO Model List of Essential Medicines 2005

Deletions

1.1

ether

2.3

colchicine

5

clonazepam

6.2.2

nalidixic acid

6.2.5

thioacetazone + isoniazid

6.6

diethyltoluamide

7.1

ergotamine

11 .1

polygeline

12.2

isoprenaline

13.7

sun protection agents

17.3

local anaesthetics, astringent, antiinflammatory as anti-haemorrhoidal

17.4

atropine as spasmolytic

21.1

silver nitrate eye solution

22.1

ergometrine tablet

22.2.2

salbutamol as tocolytic

25

theophylline, aminophylline, cromoglicic acid.

Additions

6.2.1

cefixime tablet 400 mg

6.3

clotrimazole 1%, 10% vaginal cream; 100, 500 mg vaginal tablets

17.5.2

zinc sulfate tablet or syrup in 10 mg per unit dosage

22.1

misoprostol 25 microgram intravaginal tablet; mifepristone 200 mg oral tablet - misoprostol 200 microgram tablet

22.2

nifedipine 10 mg capsule as tocolytic

24.5

methadone oral solution 5mg/5ml, 10 mg/5ml, or concentrate for oral solution 5mg/ml, 10 mg/ml

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