Switzerland - The Health Authority, Swissmedic, has released new information for health professionals concerning rare complications of sepsis and haemorrhage reported from USA and Canada following use of mifepristone (Mifegyne®) and misoprostol.
Mifepristone and misoprostol are licensed in Switzerland for medical abortion up to 49 days amenorrhoea. Recommended dosages are oral mifepristone 600 mg followed 36 to 48 hours later by 400 µg (micrograms) oral misoprostol. The cases of sepsis and haemorrhage reported from USA seem to have followed vaginal administration of misoprostol, which is unauthorized in Switzerland.
In the reported cases no fever was identified, so that it is very important to monitor patients, particularly those suffering from conditions such as tachycardia, hypovolaemia or leucocytosis. The safety information for Mifegyne® was already strengthened in December 2004 to reflect concerns and warn health professionals of these risks.
It should be noted that severe infection and sepsis can occur following abortion with both medical or surgical methods, and infection can also occur following normal and Caesarian delivery.
Reference: Des nouvelles informations sur les complications sous traitement par mifepristone. 22 July 2005. http://www.swissmedic.ch