Cytotec (generic name: misoprostol) is a drug approved by the Food and Drug Administration (FDA) for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with an associated debilitating disease.
Cytotec is often used off-label in pregnancy to induce labor and ripen the cervix despite being classified by the FDA as a Pregnancy Category X drug due to its abortifacient property, meaning the risks of prescribing the drug to pregnant women outweighs the potential benefits.
The adverse reactions associated with the use of Cytotec in labor and delivery, as listed on the drug’s label, include:
- Uterine hyperstimulation
- Rupture or perforation requiring uterine surgical repair
- Hysterectomy or salpingo-oophorectomy
- Amniotic fluid embolism (AFE)
- Severe vaginal bleeding
- Retained placenta
- Fetal Bradycardia
- Pelvic Pain
- Potential maternal mortality or fetal death
Regulatory and industry actions
- August 2000: Searle, the original manufacturer of Cytotec, issued a “Dear Doctor” letter to healthcare professionals across the country stating: “Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.”
- 2005: FDA published a Patient Information Sheet notifying the public of the risks associated with the use of Cytotec in labor and delivery. The Information Sheet stated that the FDA has not approved Cytotec for softening the cervix or inducing contractions to begin labor.
- July 10, 2015: FDA reaffirmed the content of the Patient Information Sheet notifying the public of the risks associated with the use of misoprostol in labor and delivery.
The Foundation aims to end the use of Cytotec for labor induction and has undertaken the following actions to raise awareness of the serious risks associated with the use of the drug in labor and delivery. For more information, visit our FDA Petitions page.
- November 2004: Petition delivered with 950 signatures to FDA
- June 2005 & March 2006: Delivered additional signatures to the FDA
- March 2007: Met with the Office of women’s Health Issues at the FDA with additional signatures
- October 2016: Submitted a moveon.org petition with over 4,000 signatures
- April 2017: Submitted a petition to the FDA requesting a Sentinel Study on the use of Cytotec for labor induction
How you can get involved
- Submit a comment to our petition to the FDA for a Sentinel Study on Cytotec
Our petition requests that the FDA leverage its Sentinel System, which includes data from nearly 200 million patients, to obtain a fuller picture of the risks associated with using Cytotec for labor induction and to ultimately make a decision on placing more restrictions on the drug. Simply stated, we are requesting more data on Cytotec. By submitting a comment you can help push the FDA to conduct much-needed research on this drug. You can find more information about our petition and submitting a comment at the following links:
- Submit a MedWatch Report to FDA
If you or someone you know suffered an adverse event after receiving Cytotec for labor induction, submit a MedWatch Report to the FDA. It is important that you report these events, as no one else is capturing this information. Your report can help the FDA gain a better understanding of the risks associated with the drug and push the agency to place further restrictions on Cytotec’s use for labor induction. For more info, see the links below:
Other resources on Cytotec: