Cytotec And Its Risks During Labor And Delivery
Did You or Your Baby Suffer Injuries?
Cytotec (or its generic equivalent, misoprostol) is often used in delivery rooms in Kentucky and across the country to induce labor. Cytotec does promote labor induction, but there are also reported cases of uterine rupture following its use. The only FDA approved use for Cytotec is for the treatment of ulcers, and the FDA has warned against the off label use of Cytotec for ripening the cervix or inducing contractions. Additionally, the manufacturer of Cytotec, G.D. Searle & Co., does not market the drug for induction of labor, and in fact sent out a Drug Alert to the medical community warning against using the drug to induce labor.
Even though Cytotec is a drug that is only approved to reduce the risk of gastric ulcers, it is also used in obstetrics because it has the side effect of ripening or softening the uterus and cervix. Cytotec is a popular labor-inducing solution because it is an inexpensive drug, it is easy to administer, and it provides timely induction of labor.
The American Congress of Obstetricians and Gynecologists (ACOG) endorses the off-label use of cyctotec for labor induction but limits its endorsement to women who have not had a prior cesarean (c-section) delivery or major uterine surgery. While most doctors and hospitals adhere to this ACOG recommendation, there are still health concerns about the use of Cytotec in women with a “healthy” uterus.
The risks of Cytotec include:
- Uterine rupture
- Hyperstimulation of the uterus
- Fetal distress
- Increased blood loss after delivery
- Amniotic fluid embolism
- Birth defects
- Death of baby
- Death of the mother
Because Cytotec is being used off- label as a labor inducing drug, there are no clinical trials to support the use of this drug in labor and delivery. The manufacturer of the drug, Searle, only promotes Cytotec as an anti ulcer drug, so the only test data that they have is only for the treatment of ulcers. However, Searle did find side effects associated with their clinical studies that warned of risks of hyperstimulation of the uterus, spontaneous abortion, premature labor and birth defects when pregnant women used Cytotec. Additionally, the FDA official statement regarding the use of Cytotec during labor follows:
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Doctors should discuss the risks and benefits of Cytotec with pregnant patients so that these patients can make informed medical decisions about their health and the health of their babies. Preferably, these discussions should be prior to the labor and delivery process so that women can research the pros and cons of using Cytotec. If you feel that Cytotec caused you or your baby harm during a labor and delivery in Kentucky, you can contact an attorney to help you determine if a doctor or other health care provider was negligent in administering Cytotec.