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Cytotec (Misoprostol) Labor Induction and Birth Injuries

Misoprostol, often known by the brand name Cytotec, is a medication that mimics a type of hormone called a prostaglandin. Although it was originally developed to treat stomach ulcers, Cytotec is now widely used in the field of obstetrics, including in labor induction and preventing bleeding after delivery. However, even many doctors are unaware that Cytotec is not approved for these indications, and can cause serious or even fatal complications to both the mother and the baby.

What is Cytotec?

Cytotec, or misoprostol, is a synthetic version of a particular prostaglandin. Prostaglandins are hormones that are made by many different tissues in the body. They usually act locally, close to the tissue where they’re made, rather than circulating more widely around the body as many other hormones do.

There are many different prostaglandins, and they can have different effects. Cytotec is a synthetic version of prostaglandin E1. It causes contractions of the muscle of the uterus, as well as inducing changes in the connective tissue of the cervix that make it softer and more pliable.

What is Cytotec used for in pregnancy?

One common use of Cytotec in pregnancy is for the induction of labor. As part of the process of labor, the cervix naturally undergoes a process in which the tissue becomes softer and stretchier. This allows it to dilate, or stretch far enough to allow the baby through. When this process of softening has not occurred, the cervix may be too firm to open enough for the baby to pass through it. Cytotec is used to soften the cervix, making it easier for it to dilate. This increases the chances that the baby will be delivered vaginally, rather than needing a Cesarean delivery.

Cytotec also induces contractions in the uterus, and it can be used alone for labor induction. However, in some women, the contractions stimulated by Cytotec may not be strong enough to push the baby out. In this case, either another dose of Cytotec may be given, or doctors may add another medication called Pitocin. Pitocin is a synthetic form of the hormone oxytocin, and it acts to induce strong uterine contractions.

Another potential use of Cytotec is to decrease bleeding in the mother after delivery. The drug can be given to induce strong uterine contractions, which helps to decrease blood flow to the uterus and stop the bleeding. When given earlier in pregnancy, Cytotec can also be used to help induce an abortion. This is why it’s not recommended that pregnant people take Cytotec for purposes like controlling stomach ulcers; there is a high risk that it will cause a woman to lose a pregnancy.

Why is induction of labor performed?

Labor may be induced for a number of different reasons, including:

  • Postterm pregnancy, where labor has not started on its own a week to two weeks past the due date
  • Preeclampsia, a condition in which the mother has high blood pressure and signs of damage to her internal organs
  • Other conditions that could make it dangerous for the pregnancy to continue, such as heart, lung, or kidney diseases
  • Slow growth rate of the baby, or low amniotic fluid levels
  • Chorioamnionitis, an infection inside of the uterus
  • Placental abruption, in which the placenta separates from the wall of the uterus too early
  • When the amniotic membrane has ruptured (the water has broken), but labor has not started on its own
  • The mother’s own choice, for reasons of convenience; this is known as an elective induction

The current consensus is that it’s best to avoid inducing labor unless it’s medically necessary. Rates of induction are increasing, but the procedure is associated with more complications than natural labor is. It’s important that pregnant women be counseled about the risks associated with inducing labor, so that they can make an informed decision about whether to proceed. Unfortunately, many women feel pressured by their medical providers into accepting an induction of labor, and may not be adequately informed of the risks and alternatives before consenting to induction.

How is Cytotec used for induction of labor?

When it’s used for induction of labor, Cytotec is often given vaginally. With vaginal administration, misoprostol tablets are placed at the very top of the vagina, just behind the cervix. This method delivers the medication directly to the area where its action is most needed. However, there are some cases where vaginal administration of a medication may not be considered to be safe. For example, if the amniotic membrane has already broken open, then placing a pill into the vagina may increase the risk of infection. In this case, oral administration will be preferred.

For oral administration of Cytotec, the pill may be swallowed, or it may be placed either under the tongue or inside the cheek and allowed to dissolve. Rectal administration, in which the medication is placed inside the rectum, is also possible; this is rarely used for labor induction, but is more common for postpartum hemorrhage.

Because higher doses of Cytotec are associated with a higher level of risk, it’s generally recommended that a lower dose be used at first. If it’s not effective, then another dose can be given, or a different medication may be used. Giving a second dose of Cytotec too soon after the first one can lead to dangerous side effects; it’s important for medical professionals to wait for the first dose to completely take effect before deciding whether a second dose is needed.

What are the risks of Cytotec?

Although it’s widely used for induction of labor, this use of Cytotec creates serious risks to both mother and baby. The risks include:

  • Uterine rupture, in which the uterus becomes torn.
  • Uterine hyperstimulation, in which the contractions of the uterus are too strong or last for too long, which can interrupt blood flow to the baby.
  • Meconium staining, in which the baby passes stool while still in the womb.
  • This is a sign of fetal distress.

Although rare, these issues may lead to severe complications, including:

  • The need for a hysterectomy, or removal of the uterus, in order to save the mother’s life.
  • Severe bleeding, which may require a blood transfusion.
  • Lack of sufficient blood flow to the baby during birth, which can result in complications like hypoxic-ischemic encephalopathy or cerebral palsy.
  • Respiratory issues in the baby, related to meconium staining.
  • Death of the mother.
  • Death of the baby.

Searle, the pharmaceutical company that manufactures Cytotec, has issued warnings about the risk of uterine hyperstimulation with Cytotec. On the Cytotec label, there’s a boxed warning that reads, in part, “Uterine rupture has been reported when Cytotec was administered in pregnant women to induce labor.” A boxed warning is required by the FDA in the case of a serious safety issue related to the use of a medication, and is only used in cases where the risk is considered to be substantial and severe. In August 2000, Searle issued an open letter to healthcare providers warning them that Cytotec was not approved for use in pregnant women, and that serious health risks were associated with such use.

The risks of Cytotec can be significantly reduced by appropriate medical supervision. Doctors should assess whether a patient is at risk for complications from Cytotec, and should discuss the risks and benefits of the medication with her so that she can make an informed decision about whether she wants to receive Cytotec. Giving doses that are too high, or giving multiple doses too close together, can also significantly increase the risk, so this should be avoided. Doctors also need to closely monitor the status of both patient and baby after Cytotec is given, so they can intervene quickly if serious complications start to develop.

Who is at the greatest risk from
Cytotec?

Although Cytotec can potentially cause serious complications in any pregnant person, there are some who are at greater risk from this medication. The risk is increased in those who have had:

  • A previous Cesarean delivery
  • Previous surgery on the uterus
  • Multiple previous births

In general, Cytotec should not be used in pregnant people with these conditions, as the risks outweigh the benefits.

Is Cytotec approved for induction of labor?

Because this medication is so widely used in labor induction, it surprises some people to learn that misoprostol is actually not approved by the FDA for this purpose. In fact, the FDA has issued an alert regarding the use of Cytotec to induce labor or to reduce bleeding after delivery. The alert states, “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.”

Even though Cytotec is not FDA-approved for induction of labor, it’s not illegal for doctors to use it for this purpose. In fact, once a medication is FDA-approved for any indication, doctors are allowed to use it for other purposes as well. This is known as “off-label” use of a medication. Cytotec is so commonly used for induction of labor that even many doctors may be unaware that this is an off-label use of this medication.

There are a number of reasons why Cytotec is so commonly used:

  • It’s very cheap compared with other medications.
  • It has a very long shelf life.
  • It can be kept at room temperature, rather than having to be refrigerated (as some other medication options do).
  • It’s effective at inducing labor and lowering the chances of interventions like a Cesarean birth.

What to do if you’ve been harmed by Cytotec

Although Cytotec is commonly used for induction of labor, it is not FDA-approved for this indication, and this use comes with significant risks. Unfortunately, many women feel pressured into accepting an induction of labor with Cytotec, without an adequate discussion of the serious risks involved. As a result, some families have suffered the loss of the baby, the mother, or even both of them.

If you or your family have been harmed by Cytotec, an attorney may be able to help you seek justice. Your healthcare team had a responsibility to ensure that you were fully aware of the risks of this intervention, and to use it as safely as possible, including controlling the doses and monitoring both mother and baby closely. If they failed in this duty, then you may be entitled to compensation for your losses. We’re committed to seeking justice for those harmed by the negligence of those they trusted. We invite you to contact us to discuss your case.