Cytotec (Misoprostol) and Labor Injuries

Cytotec (misoprostol), a drug designed to treat stomach ulcers, is sometimes used to induce labor. Cytotec’s use in labor induction is off-label and has not been approved by the FDA.  There is no way to accurately predict how a mother with respond to Cytotec, making its use in pregnancy risky. Because Cytotec is administered through a vaginal suppository, there is no way to rapidly discontinue its effects in the event the patient has an adverse reaction. Complications associated with Cytotec use include hyperstimulation (tachysystole), hemorrhaging, and uterine rupture. These complications can lead to conditions such as hypoxic-ischemic encephalopathy (HIE), cerebral palsy, and intellectual/developmental disabilities (I/DD).

Cytotec Use During Childbirth

What Is Cytotec Used For?

Cytotec, a prostaglandin synthetic, is the brand name for the drug misoprostol. It has been researched, developed, and approved only for use in the treatment of stomach ulcers. Cytotec is used to protect the inner lining of the stomach in order to prevent ulcers.

The manufacturers of Cytotec did not conduct research to test the safety, outcome, or efficacy of this drug as a labor induction agent, and its use as a method of labor induction is not approved by the FDA. Despite the fact that the FDA and the manufacturers of Cytotec have both issued numerous warnings to medical professionals against this off-label use, Cytotec is still given to some pregnant women in order to induce labor. When used for this purpose, Cytotec is meant to ripen (thin) the cervix and produce contractions in order to jumpstart the labor process.

The Risks of Cytotec Use In Labor Induction

There are serious risks associated with using Cytotec as an agent for labor induction. Cytotec is administered vaginally in pill form, rather than through IV or a removable vaginal insert like other labor drugs (Pitocin, Cervidil). The pill is typically cut into quarters, with one quarter administered every four hours. This poses a serious risk–if the mother or baby has an adverse reaction to the drug, it cannot be rapidly discontinued due to its immediate absorption into the body.

Because it is impossible to predict how each mother and baby will react to Cytotec, it is very dangerous to begin administration. Some of the most common adverse side effects of Cytotec use in pregnant women include:

uterine hyperstimulation; strong contractions; hypoxic ischemic encephalopathy; HIE; birth asphyxia; fetal hypoxia

In addition to these side-effects, Cytotec can also increase the need for emergency c-section or assistive device delivery due to hyperstimulation or uterine rupture frequently associated with the drug. The conditions listed above are very serious side-effects that can result from off-label, unapproved Cytotec use in pregnant women. It is because of these severe outcomes that Cytotec is not approved, and specifically contraindicated, as a labor induction agent.

Cytotec Use and Birth Injuries

If a mother and/or baby react poorly to off-label Cytotec administration, there is a dramatically increased risk of injury to the baby during the labor and delivery process. These birth injuries come as a result of hyperstimulation, uterine rupture, maternal hemorrhaging, and other side effects of Cytotec use. Birth injuries resulting from the use of Cytotec as a labor-induction agent include:

Legal Help for Cytotec Medication Errors

Cytotec misuse can cause serious and permanent injuries such as cerebral palsy and HIE. Children with these injuries often go on to require expensive, specialized, lifelong care. If you or a loved one were diagnosed with injuries or disabilities as a result of Cytotec misuse, or misuse of other labor induction drugs, 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, injury, and medical malpractice.

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Learn About Hypoxic-Ischemic Encephalopathy (HIE)


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The information contained in this page is not medical advice and should not be interpreted as such. If you have any medical questions or concerns about the topics covered on this page, please speak with a medical professional.