FDA PETITIONS

2017 Citizen Petition to the
FDA for Sentinel Study

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

Related Coverage

Medpage Today: Is Misopristol a Risky Choice to Induce Labor?

Click here to view our FDA petition

Foundation History with the FDA

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 at [email protected].

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.