FDA Petition Campaign

As an educational consumer group, the Tatia Oden French Memorial Foundation has written a letter 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 the letter campaign, please contact us at

[email protected]

Background

• November 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 & March 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.
• December 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.
• As of October 20, 2016 our MoveOn.org has over 4,000 signatures, with more coming in every week, many of which have comments of adverse effects due to Cytotec inductions.
• We are 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.

If you or someone you know and love has had an adverse outcome when induced with Cytotec, please fill out a MedWatch Online Form and submit it to the FDA. It is important that these adverse events are reported, because NO ONE ELSE is collecting this information. The more cases that are reported to the FDA, the more it pushes them take action on Cytotec and prevent it from being used for labor induction. If you have any questions about how to submit a MedWatch report, please email us at [email protected] and we can help you.

Important Resources:

• FDA ALERT for Cytotec (Misoprostol)
• Move On Petition
• Medwatch Reporting Form
• Forms to Report to FDA