German Drug Authority Issues Safety Warning Over Labour-Inducing Drug, Angusta
By Exponent News, Akure | 27th July, 2025
BERLIN — Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has issued a public safety warning concerning the use of the labour-inducing drug Angusta, following a cross-border investigative report that revealed potentially life-threatening side effects linked to the medication.
The report, originally published by Zeit and ZDF with support from Journalismfund Europe, highlighted troubling practices surrounding Angusta, manufactured by pharmaceutical company Norgine. Investigators interviewed affected families, midwives, and doctors, and reviewed clinical studies suggesting that the drug was approved through questionable review processes—allegations that Norgine denies.
The investigation further revealed that Angusta is often administered outside of recommended medical guidelines, with serious consequences. Notably, some misuses of the drug were linked to the deaths of a mother and her baby.
In response to the findings, BfArM released a public statement on June 27, 2025, confirming a rise in reports of adverse reactions. These included uterine hyperstimulation, reduced fetal heart rate, placental detachment, uterine rupture, and neonatal asphyxia—all potentially fatal complications during childbirth.
The agency noted that several cases indicated overdosing, particularly when medical staff failed to adhere to the recommended dosage intervals or used the drug during active labor—a practice that is contraindicated.
Reiterating the guidelines, the BfArM emphasized:
“Angusta is only approved for the initiation of labor. It must not be used once regular and painful contractions have started. The drug should only be administered by trained medical personnel in hospitals equipped for continuous monitoring of both the fetus and the uterus.”
Steffi Unsleber, one of the lead journalists on the investigation, described the regulatory response as validation of the team’s work.
“This is a strong confirmation that the concerns we raised were valid and taken seriously by the authorities. It’s encouraging to see our journalism contributing to better awareness and improved patient safety,” she said.
The development marks a significant step toward regulatory scrutiny over the use of labor-inducing medications and underscores the role of investigative journalism in holding medical practices accountable.
