Is it Safe to Induce Labor With Misoprostol?

Young woman patient lying at hospital bed feeling sad and worried.

Doctors induce labor for a variety of reasons, from a baby that is overdue to their own scheduling concerns. Induction of labor is generally safe and uneventful. As with any treatment administered in a hospital, you will need to consent to having labor induced with medication. Due to the anxiety and excitement of the moment, you may not ask many questions about what medication is being used or its safety, choosing instead to trust your doctor. If your doctor induces your labor with a drug called Cytotec (generic name misoprostol), you should be aware of potential risks. Is it safe to induce labor with misoprostol?

Misoprostol is not approved by the FDA for the purpose of inducing labor. Reading this, you may ask yourself why doctors would prescribe it for that purpose. The short answer is “because it works” (more on that in a moment). The slightly longer answer is “because it works, is cost-effective, and because off-label use of medications is common.”

Off-Label Uses of Medication

“Off-label” use of a medication simply means that the medicine is prescribed for a purpose (or in a dosage) other than that for which it has received governmental approval. You may be aware of a number of other types of off-label uses of medication, such as birth control pills to improve acne, or the cancer drug Avastin to treat macular edema and degeneration.

Misoprostol is approved by the FDA for use as an ulcer medication. However, numerous randomized trials found it to be more effective than oxytocin or vaginal prostaglandin E2 for inducing a vaginal within 24 hours. Some data suggests that when used appropriately in a carefully monitored setting, misoprostol is a safe and effective for inducing labor, and is cost-effective to boot.

So what’s the problem? The problem is that it can be difficult to define “appropriate” use, and that even when used “appropriately,” there is a small, but significant, risk of harm to mother or baby.

Risks of Misoprostol in Labor

Let’s take a look at what the U.S. Food and Drug Administration has to say on their website about the use of misoprostol for inducing labor:

“...pregnant women...may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. 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.

There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby.”

The FDA goes on to note that side effects are more likely in certain circumstances, such as women with a history of uterine surgery, a previous C-section, or several prior births. That does not mean that the drug is safe for women without such a history, however.

If your doctor induced labor by administering misoprostol, you should have been warned of the risks so that you could give your informed consent. If your doctor failed to warn you, or if you or your child suffered injury because your doctor chose to induce labor with misoprostol, you may be able to recover damages for medical malpractice. There are other drugs which are known to be safe and are approved for this specific purpose that your doctor could have chosen to use instead.

If You Were Harmed by the Use of Misoprostol to Induce Labor

As with other types of medical malpractice, you have only a limited period of time in which to file a claim. After that time expires, your ability to seek compensation for your injury is gone. If you suspect your doctor may have administered misoprostol, it is best to consult with an experienced Oregon medical malpractice attorney to discuss whether you may have a claim worth pursuing.

No amount of money can compensate for the loss of a child or spouse, or the ability to bear future children, but it can help to hold your medical team accountable for their negligent or reckless actions, and ease some of your financial stress as you recover from your loss.

If you have questions about the use of misoprostol to induce labor, or other birth injuries, we invite you to contact our law office to schedule a consultation.

Categories: Medical Malpractice