I have read with attention all the public concerns about the “off label” use of medications in the current medical practice. It is important for all the public to be aware that the use of misoprostol (Cytotec) is not longer investigational. Research, with all the requirements established for medical investigation in human beings, have been undertaken and completed since 1996. Many dedicated, ethical organizations had participated and the consensus is that misoprostol is a useful medication to use for the induction of labor (See Goldberg AB: Journal of Midwifery & Women’s Health. July 2004; Crane JM: Best Practice Research. Clinical Obstetrics & Gynaecology. October 2004). This research is also supported by the American College of Obstetrician and Gynecologists (See ACOG Committee Opinion. Number 283. May 2003). In this sense, please be aware that the use of medications “off FDA label” is not an individual idea, originated with the sense of “let’s see what happens” as it is implied in some of the comments posted. It will also be as important to realize that medical research is a continuum. As new evidence and technology surface so our approach to the different conditions changes

It is important for everybody involved in this discussion to be aware that the guidelines for research are very carefully followed, and that these guidelines are stringent and all of them require a written informed consent with extensive explanation and education of the subjects, in this case patients, involved.

Finally, oxytocin –a medication FDA approved for labor, has a similar safety profile that misoprostol. One more time, the issue is the judicious and appropriate use of both medications and not the medications per se (See Mozurkewich E: The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term. American Journal of Obstetrics & Gynecology 2003, pp: 1026–1030)