Cytotec (generic name: misoprostol) is a medication that entered the market in the mid-1980s. It was approved by the U.S. Food and Drug Administration (FDA) in 1988 for the prevention and treatment of stomach ulcers. However, in the 1990s, it has been found to have other notable off-brand uses in obstetrics and gynecology.
In obstetrics, Cytotec can be used to induce labor, particularly in cases where the cervix is unfavorable. In combination with mifepristone, Cytotec is used for medical abortions. It is also used for the management of postpartum hemorrhage.
In gynecology, on the other hand, it can be used to treat incomplete, missed, or septic abortions. Cytotec is often used for cervical ripening before certain gynecological procedures.
Misoprostol is currently on the World Health Organization's List of Essential Medicines, recognizing its effectiveness in certain contexts. Like all prescription drugs, Cytotec/misoprostol should only be taken under the supervision of licensed medical providers.
On the flip side, doctors may also misuse this medication. Misuse of negligent medical providers may lead to circumstances that put mothers and/or infants at risk. Any form of medical malpractice that leads to adverse outcomes warrants further legal action.
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Guidelines for Cytotec Use
When used for birthing-related purposes, Cytotec is most commonly administered vaginally for cervical ripening and labor induction. Other less common routes for these purposes include oral, sublingual, and buccal** administration.
**Placing the tablet between the cheek and gums and allowing it to dissolve slowly
Several professional medical organizations and regulatory agencies have published guidelines on the proper use of Cytotec. These international entities recognize the value and acknowledge the risks of using the drug. Some of the most prominent entities include:
- World Health Organization (WHO)
- American College of Obstetricians and Gynecologists (ACOG)
- International Federation of Gynecology and Obstetrics (FIGO)
However, note that the use of Cytotec/misoprostol is considered “off-brand” under Food and Drug Authority (FDA) standards. While they recognize its alternative medical utility (outside of ulcer treatments), they have yet to receive sufficient scientific data on the positive risk assessment of the drug. They’ve issued a public alert on its use.
Several known alternatives/complements to Cytotec are FDA-approved. These are:
- Dinoprostone (Prostaglandin E2) – is a gel that is administered through the vaginal canal. This is the only prostaglandin approved by the FDA for cervical ripening and labor induction.
- Pitocin (Oxytocin) – is a hormone that is administered through the veins or muscles depending on the need. It is a means to stimulate uterine contractions, but it is typically used after the cervix has already been ripened.
- Mechanical methods – Foley catheters or laminaria can be used to mechanically dilate the cervix.
Infant Risks When Using Cytotec Improperly
Cytotec, when improperly used for labor induction, can potentially harm your baby. Here are some of the risks to the infant:
| Fetal distress: Excessive uterine activity caused by misoprostol can lead to fetal distress. This occurs when the baby isn't getting enough oxygen due to the frequent and prolonged uterine contractions. Fetal distress can be detected through abnormalities in the baby's heart rate and may require emergency intervention, such as an urgent cesarean delivery. Meconium aspiration syndrome: Misoprostol use has been associated with an increased risk of meconium-stained amniotic fluid. If the baby inhales this meconium-stained fluid during delivery, it can lead to meconium aspiration syndrome, a serious respiratory condition that can cause breathing difficulties, lung inflammation, and in severe cases, respiratory failure. Neonatal hypoxic-ischemic encephalopathy: In cases of severe fetal distress, the baby may experience a lack of oxygen and blood flow to the brain, leading to hypoxic-ischemic encephalopathy. This condition can cause serious neurological damage, developmental delays, cerebral palsy, or even infant death. Preterm birth: If misoprostol is used too early in pregnancy or if it leads to uterine rupture, it can result in preterm birth. Preterm babies are at risk for various complications, including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and long-term developmental issues. |
Maternal Risks When Using Cytotec Improperly
At the same time, Cytotec/misoprostol can potentially cause harm to mothers when used improperly for labor induction. Here are some of the maternal risks and side effects:
| Uterine rupture: This is a rare but serious complication that can occur when misoprostol causes excessive uterine contractions. The risk is higher in women with previous cesarean deliveries or uterine surgeries. Uterine rupture can lead to severe maternal hemorrhage, hysterectomy, and even maternal death. Uterine atony: This is a condition where the uterus fails to contract properly after delivery. This can result in heavy postpartum bleeding, requiring blood transfusions or surgical intervention. Amniotic fluid embolism: This a life-threatening condition where amniotic fluid, fetal cells, or debris enter the maternal circulation – causing cardiorespiratory collapse and disseminated intravascular coagulation (DIC). |
Even when used properly and successfully, Cytotec can still present side effects. Some of its known side effects include:
- Nausea
- Diarrhea
- Fever and Chills
- Allergic reactions
- Chorioamnionitis
It's crucial for healthcare providers to carefully consider the indications, contraindications, and potential risks before using misoprostol for labor induction. Women patients should always be informed about the potential side effects and complications and be closely monitored throughout the induction process.
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Ideal Use Cases of Cytotec
While Cytotec (misoprostol) is associated with potential risks, there are certain situations where its benefits may outweigh the risks. Here are some instances where the use of Cytotec might be considered:
| CASE | DESCRIPTION |
| Intrauterine Fetal Demise (IUFD) | In cases of stillbirth, misoprostol can be used to induce labor and facilitate delivery. This can help prevent complications associated with prolonged retention of a deceased fetus, such as disseminated intravascular coagulation (DIC) and infection. |
| Postpartum Hemorrhage (PPH) | Misoprostol can be used to manage postpartum hemorrhage when other first-line treatments (i.e, oxytocin and methylergonovine) are ineffective or unavailable. It can help promote uterine contractions and reduce blood loss. |
| Induction of labor with an unfavorable cervix | When the cervix is not yet ripe (soft, thin, and dilated), misoprostol can be used to promote cervical ripening and initiate labor. This may be necessary when there are medical indications for delivery, such as prolonged pregnancy, preeclampsia, or fetal growth restriction. |
| Missed or incomplete miscarriage | Misoprostol can be used to manage missed or incomplete miscarriages, helping to expel the products of conception and avoid the need for surgical intervention (dilation and curettage). |
| Cervical preparation before gynecological procedures | Misoprostol can be used to soften and dilate the cervix before certain gynecological procedures, such as hysteroscopy or insertion of an intrauterine device (IUD). |
| Termination of pregnancy | In countries where it is legal, misoprostol can be used in combination with mifepristone for medical termination of early pregnancies. This non-invasive method can be an alternative to surgical abortion. |
Note that a case-by-case evaluation should be made before using this drug – considering the individual patient's medical history, gestational age, and any other risk factors. Failure to make these considerations could constitute medical malpractice on your provider’s behalf.
Furthermore, misoprostol should be used with caution or avoided in certain situations, such as:
- Women with previous cesarean deliveries or uterine surgeries
- Women with a history of allergy to misoprostol or other prostaglandins
- Women with active genital herpes infection
- Situations where vaginal delivery is contraindicated, such as placenta previa or transverse fetal lie
While misoprostol can be beneficial in certain obstetric and gynecological situations, its use should be carefully considered; and the potential risks should be weighed against the expected benefits. Healthcare providers should follow evidence-based guidelines and use their best clinical judgment when administering the drug – otherwise, they may be held liable for medical malpractice.
Safeguarding Your Rights and Well-being
Physicians have a legal and ethical duty to obtain informed consent from patients before providing treatment. Medical providers are also expected to provide patients with adequate education about their condition, treatment plan, medications, self-care instructions, etc. Failing to do so could warrant a medical malpractice claim – especially when it leads to adverse outcomes.
Four key elements must first be pinpointed and established before any claim is rendered valid. Medical malpractice experts typically work with trusted medical consultants during this initial investigation. These four key elements are:
| 1. Duty of Care – Was there an appropriate doctor-patient relationship? |
| 2. Breach of Duty – Did your doctor perform poorly/negligently based on accepted standards of care? |
| 3. Causation – Did your doctor’s actions/inactions directly cause you harm? |
| 4. Damages – What did these errors cost you? |
Apart from establishing your claim, the responsibilities of your medical malpractice lawyer include gathering pieces of evidence; officially filing your case; and negotiating for your compensation.
Speak to a Medical Malpractice Lawyer Today
At the Porter Law Group, our team of proven medical malpractice lawyers delivers ideal results. We take pride in helping families rebuild after unfavorable circumstances. We operate on a contingency basis – meaning you do not need to pay us anything unless we win your case. Through this approach, we can better support families during their times of need.
If you or a loved one has been a victim of medical malpractice, please reach out to us for a non-obligatory free case evaluation. You can also contact us at 833-PORTER9 or info@porterlawteam.com to schedule a consultation.
