Cytotec Labor Injuries
Cytotec (misoprostol) is a drug used for treating stomach ulcers that is used off-label and without FDA approval to induce labor. There is no way to predict how a mother will react to Cytotec, and, unlike other drugs, if there is an adverse reaction, it cannot be rapidly discontinued because it is directly absorbed vaginally. Complications from Cytotec include hyperstimulation (where uterine contractions are too strong), hemorrhaging, meconium staining, uterine rupture and an increased need for emergency C-Section. These health risk also are associated with hypoxic ischemic encephalopathy (HIE), cerebral palsy and intellectual/developmental disabilities (I/DD) in babies delivered using Cytotec.
The drug misoprostol – marketed under the name Cytotec – is a drug that is sometimes given to pregnant women to induce labor. It works by ripening (thinning or causing effacement) of the cervix and producing contractions. There are, however, serious side effects. Misuse of Cytotec can cause a ruptured uterus, umbilical cord problems, and long-term conditions in the baby such as birth asphyxia, hypoxic ischemic encephalopathy (HIE), cerebral palsy, seizure disorders and developmental delays.
The Dangers of Cytotec In Labor Induction
Cytotec was researched, developed, and approved for use as a drug to treat stomach ulcers. This is the only approved use of this drug. The manufacturer of Cytotec, Searle, never conducted clinical research to test the safety and outcome for the use of Cytotec as a labor induction agent. So its use as such is an unapproved, “off-label” use. Both Searle and the FDA have issued warnings to doctors regarding this off-label use.
Additionally, the dosage and method of administering Cytotec raises safety concerns. Unlike some of the other drugs used for labor induction like Pitocin and Cervidil, Cytotec is not administered in IV form or via removable vaginal insert. Instead, it is a pill that is inserted vaginally. The pill is typically cut into quarters, with one quarter inserted every four hours. Every pregnant woman and baby is different however, and there is no way to predict how they will tolerate Cytotec. Unfortunately, if the mother or baby has an adverse reaction to the drug, it cannot be rapidly discontinued like other labor induction drugs (eg: turning off an IV or removing a vaginal insert) since the medication is absorbed into the body.
Cytotec Use and Birth Injuries
In recent years, there have been concerns over the number of birth injuries that occurred in cases where Cytotec was used for labor induction:
- Hyperstimulation. This is a common labor problem reported with the use of Cytotec. During labor, contractions should be ideally 2 to 3 minutes apart and last 60 seconds or less. Hyperstimulation occurs when there are an excessive amount of strong contractions – usually 2 minutes or less apart – that can cause serious fetal heart rate changes (eg decreased/absent variability; progressively worsening variable decelerations; any changes of the fetal heart rate to where the fetal heart rate is not reassuring, as it was before the hyperstimulation). When hyperstimulation is evident, there is a danger that the umbilical cord is being compressed and the baby is not receiving adequate amounts of oxygen. This is an obstetrical emergency which requires a crash C-section to deliver the baby immediately to avoid hypoxic ischemic encephalopathy (birth asphyxia) and permanent brain damage.
- Uterine rupture. This is also a common side effect of Cytotec. Uterine rupture occurs when the excessive contractions associated with hyperstimulation cause the uterus to tear, either partially or completely. The baby is delivered by emergency C-section in most cases in order to avoid hypoxic ischemic encephalopathy. Hemorrhaging, or excessive bleeding, is also common and requires repair or complete removal of the uterus (hysterectomy).
- The increasing number of cases of uterine rupture prompted a Committee Opinion of the American College of Obstetricians and Gynecologists (ACOG) warning in 1999. The warning stated that Cytotec has been known to cause uterine rupture in women who have had prior uterine surgery and that the drug is not recommended for use in patients who have had a C-section or other uterine surgery.
In addition to hyperstimulation and uterine rupture, the drug has also been associated with the following: increased incidence of jaundice, increased hemorrhaging or blood loss, amniotic fluid embolism (amniotic fluid enters the mother’s bloodstream causing a stroke), meconium stained amniotic fluid, increased emergency C-section and assistive device deliveries (forceps or vacuum extractors).
Diagram: How Uterine Overstimulation Causes Placental Detachment and Fetal Hypoxia
Legal Help for Cytotec and Labor Induction Medication Errors
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If you or a loved one were diagnosed with permanent injuries or disabilities as the result of cytotec misuse or other labor induction medication errors, we encourage you to learn more about your legal options. Our team of birth injury lawyers has decades of experience handling cases specifically related to birth trauma, birth injuries, medical malpractice, Cytotec, and labor and delivery medication errors.
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Video: Hypoxic Ischemic Encephalopathy (HIE)
Watch birth injury lawyer Jesse Reiter discuss the causes of a lack of oxygen in a baby’s brain during or near the time of birth (birth asphyxia), what can be done to prevent this, and the long-term outlook for children who experienced birth asphyxia.
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