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.
- Citizen Petition Press Release
- Citizen Petition Fact Sheet
- How to Submit a Comment Online to the FDA Guide
- Submit a MedWatch Report Video