Misoprostol (marketed as Cytotec) Information
FDA ALERT – Risks of Use in Labor and Delivery
This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.
There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.
Kind of scary right?
Then today I was reading about the use of this drug in the book "Ina May's Guide to Childbirth" by Ina May Gaskin. She took it upon her self to look at 49 case studies of the drug in which 5,439 women participated. Here are the results she reports in her book:
- 25 women had ruptured uteri
- 16 babies died
- 2 women had such profuse bleeding that they had to have an emergency hysterectomy
- 2 women died
I have also read the account of Madeline Oden. Her daughter was given Cytotec in December 2001. She tells how her daughter Tatia Oden French was 32 years old and about to have her first child. Here is what she writes in The Journal of Perinatal Education:
"In December 2001, my 32-year-old daughter, Tatia Oden French, entered a well-known hospital in Oakland, California, to have her first child. She was in perfect health. The baby was in perfect health. The pregnancy was “unremarkable.” Tatia was almost 2 weeks past the due date, and the doctor wanted to induce her. After much stalling on Tatia's part, she reluctantly agreed to submit to induction. The agent used was Cytotec (misoprostol). None of the medical staff told us anything about Cytotec. When I asked what Cytotec was, I was told it is “the standard of care… we use it all the time.” Tatia said it was “not approved by the FDA [U.S. Food and Drug Administration] for use in labor.” Nothing else was said about the potential side effects, the dangers to the mom and child, or the alternatives. However, phrases such as “You don't want to go home with a dead baby, do you?” were said. The pressure was on. Tatia conceded. She told me to go home and that she would call me, believing it would be a long night. We told each other we loved each other and, having not decided on which specialty she would focus on in medical school, she smiled and said, “Maybe I'll be an OB/GYN.”
Ten hours after Tatia was induced with Cytotec, both she and her baby girl, Zorah, were dead. When I asked Tatia's doctor what happened, she just said, “It was a very rare adverse effect of Cytotec, but it does happen.” Still not comprehending what had just happened, I heard myself ask the doctor, “Could you at least tell me that you will not use that drug again?” Surprised, she looked at me and said, “No, I cannot promise that.” Finally, my two sons, Tatia's dad, Tatia's husband, and I were allowed into the operating room where Tatia and Zorah were lying perfectly still. We gathered and said a prayer around both of them. When I left the hospital, it was raining and gray and cold. I heard myself say out loud, “That drug is going to go away.”"
I cannot imagine what that family must have went through and are still going through. This is a dangerous drug, and from my opinion should not be used for this at all. Please make sure you are aware of what you are consenting to when you go to the hospital. If you do not understand what something is, make sure you ask questions. You want to keep yourself and your child safe, so BE INFORMED.
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