The FDA Approval Process and Cytotec
In the US, before any drug is approved for distribution by the FDA, it must first go through rigorous clinical testing to ensure that it is safe and effective. If the FDA deems the drug fit for consumers, it is approved for intended use only. Physicians are still free to prescribe drugs for whatever they deem medically appropriate, even if the drug is not prescribed for its intended or approved use. This is called “off-label” use.
Cytotec (also known as misoprostol) is a drug approved for gastric ulcer treatment. It is also very popular among obstetricians for the off-label use of labor induction. Cytotec ripens the cervix (thins it out or causes effacement) and promotes contractions. The problem with using Cytotec off-label for labor induction is that scientific evidence has shown there are serious, often fatal, risks associated with its use.
Birth Injuries Occur When Labor Is Induced with Cytotec
These risks were cited in a warning letter in 2000 from the drug’s manufacturer (Searle) to US obstetricians and gynecologists regarding the use of Cytotec for labor induction. The letter also cited that Searle did not intend to study or support the use of Cytotec for induction of labor or cervical ripening. Shortly after, the FDA issued a Safety Alert restating the risks contained in the letter from Searle. The risks include:
- Hyperstimulation. This is where the uterus produces severe, excessive contractions usually two minutes or less apart.
- These can cause serious fetal heart rate changes when the baby’s heart rate has lower or absent variability, has progressively worsening variable decelerations, or is non-reassuring (concerning).
- Hyperstimulation can also lead to uterine ruptures (partial or complete tears in the uterus) and deprive the baby of oxygen by compressing the umbilical cord. This usually requires a crash C-section to deliver the baby immediately to avoid hypoxic ischemic encephalopathy (birth asphyxia) and permanent brain damage.
- Amniotic fluid embolism. This is an obstetrical emergency where amniotic fluid enters the mother’s bloodstream causing a stroke or cardiorespiratory collapse.
- Meconium staining. Meconium is the first bowel movement of an infant consisting of what is ingested while in the uterus. It usually stays within the infant’s intestines until birth but sometimes (eg: with fetal distress) it is ejected into the amniotic fluid prior to birth or during labor. Respiratory problems can occur if the baby inhales the contaminated amniotic fluid.
- Jaundice. An infant’s immature liver is sometimes unable to effectively remove bilirubin and excrete it into the intestines as bile. As a result, bilirubin builds up and the infant’s skin and whites of the eyes become yellow (jaundiced).
- Increased hemorrhaging or blood loss.
- Increased risk of emergency C-section and assistive device deliveries (forceps or vacuum extractors).
The primary problems with the off-label use of Cytotec include:
- Dosage. Because Cytotec was never intended for labor induction, no dosing recommendations exist. The first doctors to administer the drug in the 1990s for labor induction used their patients as guinea pigs.
- Administration. Cytotec is only available in pill form. The pill is cut up in quarters; a quarter is typically administered vaginally every four hours. The pill dissolves immediately and is absorbed into the body. If the mother or baby has an adverse reaction, there is no way to quickly stop the medication and the birth injuries above may result.
- No informed consent. In most cases, pregnant women are not told in advance that their labor will be induced using Cytotec. Women are not afforded the opportunity to investigate the drug nor decline it.
- Safer alternatives. There are other labor-inducing drugs on the market like Pitocin and Cervidil. These drugs are administered using IV and removable vaginal insert. If a mother or baby has an adverse reaction to either of these drugs, they can be immediately removed.
Risks of Cytotec Use Outweigh Benefits
With this many risks and uncertainties associated with this drug, it’s hard to understand why doctors continue to use it for labor induction. Using an off-label drug violates the standard of care and puts the lives of pregnant women and their unborn children at risk unnecessarily.
If you or someone you know is pregnant and will have a labor induction, do your homework and ask questions about the type of induction drug that you will be given. It is your right to know about the potential risks associated with any drug. It is also your right to refuse a medication.
What to Do if Your Child Sustained a Birth Injury Due to Cytotec
Call Reiter & Walsh ABC Law Centers if your child has been diagnosed with cerebral palsy, intellectual impairments or other permanent birth-related injury. Our specialized attorneys and renowned medical experts will review your case and determine if Cytotec caused the injury. E-mail or call us toll-free 888-419-2229 for a free consultation.