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# Sentinel Query on Cytotec Adverse Events Sought
- URL: https://www.fdaweb.com/sentinel-query-on-cytotec-adverse-events-sought/
- Published: 2017-04-26T12:00:00.000Z
- Updated: 2026-09-14T22:19:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138557

The Tatia Oden French Memorial Foundation is petitioning FDA to conduct a Sentinel query to assess rates and severity of adverse reactions associated with the unapproved use of misoprostol (Cytotec and others) for cervical ripening and induction of labor to determine whether regulatory action is needed to assure patient and nenonate safety. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-2563-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says collecting the Sentinel data could lead to updates to existing prescribing information, safety alerts, or other regulatory action deemed appropriate by FDA.

“Published literature, single case reports, and its reported pharmacological action have connected misoprostol use with serious adverse effects such as uterine rupture and other events related to hyper-stimulation,” the petition says. “We are concerned that these types of serious events may be underreported to the FDA Adverse Event Reporting System because Cytotec is being used off-label when it is used for cervical ripening and/or induction of labor.” The foundation says that a Sentinel query “could provide a more complete understanding of its adverse event safety profile, including a better understanding of rates and severity of adverse events, risk factors for such events, and any differences in risk based on dose or route of administration.”