geburts abc

Cytotec and Misoprostol off-label use

Consent by signature

Due to several letters from women who have had bad experiences with a non-approved contraceptive, we feel obliged to inform you about it.
This concerns the stomach medication Cytotec, which is used as a contraceptive. Its effect on the muscles of the uterus was discovered by chance. Women are presented with a form to sign, usually when the birth is already in progress.
Cytotec is also administered under the name "Misoprostol". It is a so-called "off-label drug" which is considered 'legally problematic'. Drugs are called "off-label drugs" if they are used beyond the scope of a marketing authorisation. This means the prescription/use of an authorised ready-to-use drug outside the use authorised by the drug authorities, i.e. use outside the area of application (indication) or an unauthorised method of use.
A person concerned provides us with the signature form: Cytotec signature sheet

A gynaecologist interviewed by us recommended refusing to sign with the addition: "This explanatory text does not correspond in any way to the demand recognised in evidence-based medicine for comprehensible patient information that plausibly presents all options for action and allows me to participate independently in the decisions of the obstetricians. I am not prepared to take any personal responsibility on the basis of this text."
We assume that no woman during delivery is able to express such a sentence. However, you can see from this recommendation what an unreasonable demand it is, even from a doctor's colleague's point of view.
If you need a birth initiation, you can state that you will only agree to prostaglandins.