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We have recently (Jan 2008) completed an extensive revision of the guidelines, as well as making changes to the availability, and bibliography pages. The new guidelines were produced by an expert group, convened by WHO, who met in Bellagio, Italy in February 2007. Although they do not represent the official WHO guidelines, the group thought it important to publish the conference papers as soon as possible because of the ongoing confusion over optimal dosages for different indications. The full papers are published in a supplement to the International Journal of Gynecology and Obstetrics (Dec 2007, vol 99).
Misoprostol approved in Uganda, Nigeria and Ethiopia for PPH
The Californian based non-profit making organisation Venture Strategies 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. The Uganda registration was approved in June 2008.
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.
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