On April 26, 2017, the Tatia Oden French Memorial Foundation has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) for a Sentinel Study on the unapproved use of misoprostol (marketed as Cytotec) for labor induction. Cytotec, a drug approved by the FDA to treat gastric ulcers, is commonly used off-label to induce labor despite being contraindicated for pregnant women. Through this petition, the Foundation ultimately aims to restrict the use of Cytotec in labor induction.
The full petition can be found online here.
Additional Materials
Citizen Petition Press Release
Citizen Petition Fact Sheet
How to Submit a Comment Online to the FDA Guide
Submit a MedWatch Report Video
Medwatch Reporting Form
FDA ALERT for Cytotec (Misoprostol)
Move On Petition
Forms to Report to FDA
Related Coverage
Medpage Today: Is Misopristol a Risky Choice to Induce Labor?
As an educational consumer group, the Tatia Oden French Memorial Foundation has written multiple letters to the FDA regarding Cytotec. We seek to have the FDA issue much stronger warnings to the public regarding the side effects of this “ulcer” drug, when used to induce labor. If you would like more information regarding our communications with the FDA, please contact us a momoden@sbcglobal.net.
We are also currently developing a Citizen’s Petition that we will submit to the FDA to request a Sentinel Study of Cytotec (misoprostol). Please continue visiting our site to receive updates on this petition and how you can contribute to help us make a big impact on the FDA.
Below you will find a full timeline of the work we have conducted with regard to the FDA.
Nov. 2004
The Tatia Oden French Memorial Foundation delivered a petition with over 950 signatures to the FDA in person.
May 2005
FDA published an FDA Alert regarding the use of Cytotec for inducing labor and/or ripening the cervix. The FDA Alert came in the form of a patient information sheet for pregnant women and was published on the FDA website, however, there has NOT been a public statement made by the FDA regarding this alert on Cytotec. The Alert states that the FDA does NOT approve the use of Cytotec for inducing labor and that when used for this purpose Cytotec (Misoprostol) has been known to cause a torn uterus, which can lead to a hysterectomy and death of the mother or baby.
June 2005 + May 2006
We delivered additional signatures to the FDA
March 2007
We met again with the Office of Women’s Health Issues at FDA and this time submitted a total of 1,923 signatures, 70 of which were from women who had catastrophic events after Cytotec inductions. Some of the women lost their baby, while others had uterine ruptures. In this instance, the FDA did not take our signatures in person, so the petition was mailed in.
Dec. 2012
We received a response to our petition from the FDA. They have denied our request to create a medicine guide for Cytotec Inductions. They feel that the ALERT on Cytotec inductions found on the FDA website is sufficient public notification. They are, however, in discussion with the American Congress of Obstetricians & Gynecologists (ACOG) regarding how the mother should be informed about the risks and benefits of Cytotec inductions during discussions of the labor and delivery process. We feel this is a big step and partial “win”. We continue to deliver the signatures and comments to the FDA and work with organizations and individuals who are also attacking the issue of Cytotec inductions.
July 2015
FDA issued an updated Alert on Cytotec (Misoprostol) on their website, but did not make any public announcement of the update, nor did they specify the updates that were made.
October 2016
Our MoveOn.org garnered over 4,000 signatures, with more coming in every week, many of which have comments of adverse effects due to Cytotec inductions.
April 2017
The Tatia Oden French Memorial Foundation submitted a citizen petition to the FDA for a Sentinel Study on the unapproved use of Cytotec for labor induction. The petition received over 50 public comments in support of the request. See the top of this page for more info.
October 2017
The Tatia Oden French Memorial Foundation received an interim response from the FDA regarding the Foundation’s citizen petition for a Sentinel Study on Cytotec. The response states: “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials…We will respond to your petition as soon as we have reached a decision on your request.”
The Foundation is still awaiting a decision from the FDA…
tatia.org 