The Tatia Oden French Memorial Foundation

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The petittion which The Tatia Oden French Memorial Foundation submitted, in person, to the FDA on Nov. 22, 2004 can now be viewed and signed on line. In Nov. 2004, we submitted over 950 signatures to the FDA and are continuing the petition on line. We delivered an additional 600 signatures in June. 2005 to the FDAand again in March of 2006. In March of 2007, we met again with the FDA, Office of Women's Health Issues, and again  we came with more signatures and comments. The total signatures on line was 1923 signatures. 70 of those were from women who had catastropic events after Cytotec inductions. Some  of the women lost their baby, some had uterine ruptures.This time, the FDA did NOT take our signatures in person... so the petition has been mailed in. You can view and sign the petition regarding Cytotec by clicking on the following link.cytotec petition (NOTE: Your email address does not appear on the petition. Please leave us your contact information by emailing us at zorah@tatia.org so we can contact you, especially if someone you love has been given Cytotec to induce their labor and had adverse outcomes...This is very important because NO ONE else is collecting the data on adverse outcomes). Please see the FDA Alert on Cytotec, directly below this article, that was issued the week of May 16, 2005.
Regarding the Medicine Guide which we want  to see the FDA create about Cytotec... they told us in so many words... it would not happen.... there is not enough evidence based information they said.  If you or someone you know has been a victim of a cytotec induction... PLEASE fill out a Med Watch form . You can read all the instructions and download the form by clicking on MEDWATCH.  Please fill out this form and send it to the FDA.

The FDA Dockets site exhibits the petition that The Tatia Oden French Memorial Foundation has submitted to the FDA. The signatures are not available on line. However, by clicking on the link below you will be directed to the FDA Docket site for the petition and you can then click on the petition itself to read it. The you can write an email to the FDA at the following address: fdadockets@oc.fda.gov
Be sure to use the docket number which is 2004P-0522/CP 1. dockets As of Dec. 7, 2012, the FDA has sent us, and ACOG, a response to our petition. Pleaseclick on the link below to see the response sent to us from the FDA .

FDA Response

FDA Alert On May 16, 2005, the 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 informaiton sheet for pregnant women and was published on the FDA webpage, 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 ( or Misoprostol) has been known to cause a torn uterus which can led to a hysterectomy and death of the mother or baby. The FDA Alert in its entirety can be viewed by clicking on the following link:

FDA Alert on Cytotec