Controversial drug: Cytotec import ban

After reports of serious side effects during labor induction with Cytotec, authorities and importers are pulling the cord. The drug will no longer be sold in Germany.

The Cytotec drug will no longer be sold in Germany in the future. This was announced by the importing companies. “After extensive consideration and decision in agreement with the licensing authority,” Kohlpharma wrote at the request of the Bavarian broadcasting and “BuzzFeed News Deutschland” have “completely” renounced Cytotec’s approval.

The company EurimPharm Arzneimittel will not sell Cytotec in Germany either. It followed the “controversial discussion last year about the advantages and disadvantages of Cytotec in ‘unauthorized use'”.

Notification of serious side effects

In February last year, a heated debate broke out in the halls of the German district about how to deal with Cytotec. Doctors use the drug to induce artificial labor. As part of freedom of therapy, this is allowed under so-called “off-label use”, although Cytotec has never been approved for obstetric medicine.

BR research, Munich report and “Süddeutsche Zeitung” and later “BuzzFeed News Deutschland” reported cases where women suffered a “labor storm” after receiving Cytotec. In individual cases, women had their uterus ruptured, children were born oxygen starved, with permanent brain damage, which according to side effect reports and reports is linked to Cytotec. According to experts, the main problem is not the drug itself, but how it is used, for example, inaccurate or excessive doses and insufficient control of the mother and child.

Spahn planned to withdraw approval from 2020

Federal Health Minister Jens Spahn had already personally weighed in on the matter after the report in February 2020 last year. This shows an internal mail that BR research and “BuzzFeed News” is available.

According to the document, Spahn had already planned to revoke Cytotec’s import license at that time. Only now have the importing companies and the Federal Institute of Medicines and Health Products (BfArM) in charge reached an agreement.

The authority wants “a quick cessation of marketing”

The BfArM contacted the importers again in mid-March. The goal was “to work towards a rapid cessation of marketing of the drug,” the authority said on request. The companies have been informed of a possible revocation of the import license.

The antecedent, according to the authority, is the risk associated with Cytotec of “serious damage to the health of pregnant women and the fetus due to improper use.” After investigation of BR and “BuzzFeed News”, the BfArM has now received seven reported deaths in connection with Cytotec.

Over 400 suspicious transaction reports

After the report, suspicious transaction reports skyrocketed. In all, there are now more than 400 reports from women and medical personnel of complications associated with the drug. According to the BfArM, causality has not been proven in individual cases.

The number of suspected cases reported last year led to a so-called Rote-Hand-Brief, an information letter from the authority to doctors. The BfArM cautions against tablet splitting. It also states that there are insufficient data to assess the risk-benefit ratio of Cytotec for induction of labor. There are approved and tested alternatives.

Specialized society defends active principle

In the controversy surrounding the use of Cytotec, the German Society of Gynecology and Obstetrics eV (DGGG) noted how effective and safe the active ingredient in the tablet is. Misoprostol has been well investigated in more than 80 randomized controlled studies.

Upon request, the specialized company did not comment on the current import ban. According to surveys, around half of German clinics use Cytotec to induce labor. If doctors want to continue using the drug, there is only one option left, according to the BfArM: individual imports based on prescription.

The women’s network praises the approach

“The fact that the tap is turned off is a good, ingenious and great approach,” said a spokeswoman for “Cytotec-Stories,” a women’s network that was founded last year in the course of reporting.

“Cytotec Stories” now belong to more than 80 families who feel harmed by the use of Cytotec. Many are litigating at their maternity hospital. “It’s actually a scandal that has only happened now,” the spokeswoman said. “But at least it happens.”