The misuse of Cytotec and the risks associated with its use in labor induction are perfect examples of the many reasons why informed consent is so crucial. The previous poster is mistaken when he claims that research has established Cytotec's safety. As the editor of the British Journal of Obstetrics and Gynaecology commented in the January 2004 issue, the studies done to date have been "too small to provide evidence on rare but important outcomes." Attempts at meta-analysis of the data (such the Journal of Midwifery and Women's Health article the previous poster references) are all but meaningless because of the serious disparities among the treatment protocols used. Amniotic fluid embolism is perhaps the most disturbing "rare but important outcome" associated with the use of Cytotec, yet women are rarely, if ever, informed of this risk. In fact, Cytotec was introduced into obstetrical practice before any research on it had been done at all, and thousands of women and babies have experienced adverse outcomes without ever having been informed of the lack of data on the drug's safety, the "rare but important outcomes" associated with it, or the fact that it's not FDA approved for labor induction. No one is suggesting a ban on the off-label use of Cytotec or any other medication. We're simply asking the BoM to consider including informed consent for off-label use of drugs in its revised ethical standards. Thank you for the opportunity to comment. Katherine Prown