What if non-pregnant women are taking misoprostol

Import stop for medication to induce labor

The controversial drug Cytotec, which doctors used as a so-called off-label preparation for induction of labor outside of the approval process, is no longer marketed in Germany. At the request of the Bavarian Broadcasting Corporation, the relevant importing companies announced this. Federal Minister of Health Jens Spahn (CDU) had already planned the revocation of import approval for Cytotec in February 2020. After the responsible Federal Institute for Drugs and Medical Devices (BfArM) threatened a revocation procedure, the importing companies voluntarily returned their approval.

In the past few years, Cytotec has gotten into the discussion. Doctors used the drug to induce labor, although it is not officially intended for this. It was approved in Germany as a treatment for duodenal and gastric ulcers and for the prevention and treatment of gastric mucosal inflammation. When used to induce labor, there were sometimes serious side effects such as uterine tears or labor storms. However: "An induction can lead to overstimulation of the uterus with all prostaglandins - but also with oxytocin", explains Professor Dr. Franz Kainer, Chief Physician of the Department of Obstetrics and Prenatal Medicine at the Hallerwiese Clinic in Nuremberg.

Off-label use is not uncommon

It is a regular occurrence in Germany that doctors use preparations that are not officially approved for the respective use. This is subject to your freedom of therapy - if you inform the patient separately about the drug beforehand and obtain their consent. This happens more often with pregnant women, as drug studies are carried out cautiously with them and there are therefore comparatively few drugs approved for them. "Studies on pregnant women are relatively expensive for pharmaceutical companies because there are high requirements," explains Werner Rath, University Professor for Gynecology and Obstetrics at the Medical Faculty at the University Medical Center Schleswig Holstein, Campus Kiel. "This is often not worthwhile with cheap drugs. They are then simply not approved for use in pregnant women."

Werner Rath and colleagues carried out a survey on Cytotec in German maternity clinics in 2013 and 2014, which was published in 2015. "We found that almost 70 percent of clinics use it," he says. "Last year, this rate was likely to have been well over 80 percent."