2025-07-08
BERLIN - Reporting on the potentially severe side-effects of labour-inducing drug Angusta, produced by Norgine, prompted Germany's Federal Institute for Drugs and Medical Devices (BfArM) to issue a warning on the use of the medication.
The original story, produced by a cross-border investigative team, spoke to families, midwives and doctors affected, and reviewed studies. It uncovered both how Angusta was approved after questionable clinical review procedures - a claim denied by the drugmaker - and how the pill's administration by medical professionals often goes against recommended uses. Cases where the drug was misused led to the death of a mother and a baby.
In the aftermath of the investigation’s publication in Zeit and ZDF, the BfArM wrote in a statement on June 27th 2025 that it saw an increase in reports about adverse side effects connected to the use of Angusta, such as "uterine hyperstimulation, reduced fetal heart rate, premature placental detachment, uterus rupture, neonatal asphyxia.” These can cause severe complications around birth.
The Institute’s statement read: "Some of these cases indicate overdose, in particular non-compliance with the recommended dosage intervals and contraindicated use in already started regular and painful contractions.”
Another post by the Institute reminded doctors: "Angusta is only approved for birth initiation. The use of birth already started or in the case of regular and painful labor is contraindicated. Angusta may only be administered by trained medical personnel in hospitals where there are possibilities for continuous monitoring of the fetus and uterus."
According to Steffi Unsleber, a journalist who reported the story, “this is a strong confirmation that the concerns we raised were valid and taken seriously by the authorities,” adding, “it’s encouraging to see our work contributing to greater awareness and patient safety.”
