Pabal, Duratocin
Evidence Grade B — Strong clinical evidence. 403 published studies, 243 human. 96 registered clinical trials.
Carbetocin is a long-acting version of oxytocin that has been studied to prevent dangerous bleeding after childbirth. It is registered in over 80 countries outside the US but has never received FDA approval. A heat-stable formulation — one that does not need refrigeration — was added to the WHO Essential Medicines List, addressing a critical need in tropical and low-resource settings where standard oxytocin degrades in the heat.
403 published studies: 243 human, 72 animal, 17 in-vitro, 73 reviews
Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019.
The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.
Carbetocin activates the same oxytocin receptor as natural oxytocin, producing uterine contractions. Its molecular structure includes a modification that prevents the body from breaking it down as quickly as natural oxytocin, extending its duration of action to approximately 40 minutes compared to oxytocin's 3–17 minutes. This longer action means a single dose may be sufficient where oxytocin would require a continuous infusion.
The WHO-sponsored CHAMPION trial (over 29,000 women) found heat-stable carbetocin non-inferior to oxytocin for preventing postpartum haemorrhage after vaginal delivery. This matters because standard oxytocin requires refrigeration, which is often unreliable in the regions where postpartum haemorrhage is the leading cause of maternal death. The US market has not been pursued, likely because reliable cold-chain oxytocin is ubiquitous in US healthcare facilities. A development programme for Prader-Willi syndrome (a genetic condition) failed, closing the most advanced pathway for major-market development. Carbetocin's global health significance rests on the heat-stable formulation for resource-limited settings.
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy
Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Health Canada Market Authorisation
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
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