Follow-up on the off-label use of Cytotec

14.10.2020

Question for written answer E-005602/2020
to the Commission
Rule 138
Derk Jan Eppink (ECR)

In June, I submitted Written Question E-003300/2020 on the potentially harmful effects of the off-label use of Cytotec to induce labour. The answer I received from the Commission does not outline its planned actions nor does it address my specific questions on the topic, which is regrettable given that patients are not being properly informed about the potential risks of off-label use.

Given that the Commission has stated that the next periodic safety update assessment will take place in 2020:

• 1.When exactly will the next periodic safety update take place, and will the Commission collect full data on the number of patients affected by the off-label use of Cytotec across all EU Member States?
• 2.What are the informed consent requirements for the off-label use for Cytotec, and what are the consequences if these requirements are not respected? What rights do patients and family members have in the event that the informed consent requirements are not respected?
• 3.Given that the off-label use of Cytotec has been restricted in Germany and France, what action is the Commission taking to coordinate Member State responses and actions in order to prevent further harm to mothers and babies?