Cytotec: how risky is it during childbirth?

and Florian Tiefenböck, doctor

Christiane Fux studied journalism and psychology in Hamburg. The experienced medical editor has been writing magazine articles, news and factual texts on all conceivable health topics since 2001. In addition to her work for, Christiane Fux is also active in prose. Her first crime novel was published in 2012, and she also writes, designs and publishes her own crime plays.

What is Cytotec?

Cytotec was developed by the pharmaceutical manufacturer Pfizer for the treatment of gastric and duodenal ulcers. Its active ingredient misoprostol belongs to the hormone-like so-called prostaglandins.

One side effect of misoprostol is that it also causes labor. That is why it has also been used in obstetrics for many years - although it is actually not approved for this. For this so-called "off-label use" beyond the actual purpose, doctors decide within the scope of their therapeutic freedom.

According to an unpublished study by the University of Lübeck, the drug is used in around half of German maternity clinics, reports the Süddeutsche Zeitung (SZ).

What are the dangers of using Cytotec in obstetrics?

Induction of labor with medication is always associated with risks - no matter which medication is used. Therefore, it is always carefully considered whether such a measure is necessary or whether the natural course of labor can be awaited.

However, there is a suspicion that mother and child could be more at risk from misoprostol than from comparable agents. In fact, cases have become known in which the active ingredient has overstimulated the uterus of women. Then the contractions can be so violent that the uterus ruptures, which can lead to life-threatening bleeding.

A so-called labor storm is particularly dangerous for the child. The contractions follow one another extremely quickly. The child does not get enough oxygen and can suffer permanent brain damage - or even die. But: Such serious complications are also possible with other drugs that trigger labor.

Therefore, when using contractions, the mother and the unborn child must be closely monitored. With a cardiotocogram (CTG), contractions and the child's heartbeat are continuously monitored. Alarm signs are, for example, a greatly slowed or intermittent heartbeat of the unborn child. Doctors then quickly bring the child by emergency caesarean section.

How often do problems arise with Cytotec?

The frequency of serious complications from misoprostol is nowhere recorded. According to SZ, the Federal Institute for Drugs and Medical Devices (BfArM) has only received one corresponding notification. The Bavarian Broadcasting Corporation and the SZ want to have come across other cases during their research. In the meantime, numerous women have reported, reports the media.

Why this discrepancy between side effect reports and officially reported cases?

One reason could be that doctors do not need to report such usage complications. There is only a reporting obligation for the manufacturer, in the case of Cytotec for Pfizer. However, the company withdrew the product from the German market in 2006. The drugs used in this country are now obtained from abroad.

Why are doctors allowed to use Cytotec in obstetrics?

Off-label drug use is a common practice. Patients with rare diseases for which there are no approved drugs benefit from this, for example. Most drugs are also only tested on adults for ethical reasons. The treatment of children is therefore often only possible “off label”.

In such cases, the doctor has what is known as therapy freedom. He is therefore free to decide, to the best of his knowledge and belief, which treatment he would like to suggest to the patient. However, he must explain the risks and treatment alternatives to the patient in detail, especially before off-label use.

What use is Cytotec approved for?

For a drug to be approved, extensive clinical studies must prove its quality, safety and effectiveness. However, this does not apply to off-label use.

Pfizer had only obtained approval for Cytotec as a stomach drug, but not as a birth-inducing drug. There is also a lack of studies on the appropriate dosage as a labor medication.

Are there approved alternatives to Cytotec?

The hormone oxytocin is approved as a birth-inducing drug. There are also substances related to misoprostol that are approved for induction of labor. But they are said to be less effective.

What do experts say about the use of Cytotec in obstetrics?

Critics, such as the gynecologist Prof. Peter Husslein, who heads the University Women's Clinic in Vienna, claim that Cytotec has caused numerous deaths. In view of approved alternatives, he sees no reason to use an unapproved drug like Cytotec, Husslein told the SZ.

However, some doctors rely on Cytotec because it makes childbirth faster. In addition, the approved alternative preparations are significantly more expensive. According to SZ, instead of a few cents, three-digit amounts are due for the use of alternatives.

Does Cytotec have any advantages?

Another aspect is the reliability of misoprostol. Sometimes its use can prevent a caesarean section.

Prof. Michael Abou-Dakn, chief physician at the Clinic for Gynecology and Obstetrics at St. Joseph Hospital in Berlin-Tempelhof, told the Ärztezeitung that Cytotec was much more effective than its alternatives. In addition, the spectrum of side effects is roughly comparable for all birth-inducing agents.

This is also confirmed by the renowned Cochrane Foundation, which examined the effects and risks of means for induction of labor in a survey study updated in 2018. For all common active ingredients, they are comparable to those of misoprostol. 75 studies with a total of almost 14,000 participants were evaluated.

The Cochrane study also shows that serious complications were so rare overall that no differences in the risks of the various drugs could be found. According to the institute, around twice to ten times as many cases would have to be examined for this.

Are there any recommendations for using Cytotec?

The International Association for Gynecology and Obstetrics (FIGO) endorses the use of misoprostol. However, she recommends that the medication for inducing labor be administered in doses of no more than 25 micrograms every two hours.

The World Health Organization (WHO) recommends the same approach. Critics warn, however, that significantly higher doses are always given in everyday clinical practice.

The medical guidelines of German specialist societies on the use of prostaglandins in obstetrics were last revised in August 2008 and are out of date. We are currently working on an update. With the indication of the necessary education, the guideline named misoprostol as an “off-label” -usable labor medication.

What can expectant mothers do?

Pregnant women should insist that all treatment alternatives are explained in detail and that they be fully informed about possible risks. For example, whether the induction of childbirth is actually necessary, what options are available for induction or whether a caesarean section would be the better alternative.

This duty to provide information on the part of doctors is particularly important when using drugs off-label. Many questions can be answered calmly in the run-up to the birth, for example in conversation with the outpatient gynecologists.

If a birth has to be initiated, there is still enough time for an interview in the clinic.

Read everything about the active ingredient misoprostol, its mode of action, application and side effects!

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