For the prevention of excessive bleeding after childbirth heat stable carbetocin has been added to essential list t

• Heat-stable carbetocin has been added to the WHO Essential Medicines List of uterotonics for the prevention of excessive bleeding after childbirth

• Excessive bleeding after birth, also known as postpartum haemorrhage (PPH), is the leading direct cause of maternal mortality worldwide

• WHO guidelines recommend heat-stable carbetocin for PPH prevention in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics

• Heat-stable carbetocin was developed to address limitations in refrigeration and cold-chain transport of medicines in low- and lower-middle income countries

Due to postpartum haemorrhage (PPH), a woman was rushed to have emergency blood transfusions after childbirth. Her husband felt helpless, but thankfully she recovered.

A Pharmaceutical company today welcomes the World Health Organization’s (WHO) addition of heat-stable carbetocin to the WHO Model List of Essential Medicines (EML) of uterotonics for the prevention of excessive bleeding after birth. The EML identifies medicines the WHO deems essential for addressing the most important public health needs globally. 

 

Every year, 14 million women are affected by excessive bleeding after birth, also known as postpartum haemorrhage (PPH). Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide, causing approximately 70,000 deaths per year, 99% of which occur in low- and lower-middle income countries.

“The WHO’s addition of heat-stable carbetocin to the Essential Medicines List brings us one step closer to tackling this life-threatening condition that impacts thousands of women and their families,” said a researcher. “This milestone is thanks to collaboration from stakeholders around the world, and demonstrates how work across both the public and private sectors can help achieve development goals in global health. As the manufacturer, is now seeking registrations for heat-stable carbetocin and, once approved, our priority is to make heat-stable carbetocin available at an affordable and sustainable price in public sector healthcare facilities in low- and lower-middle income countries where cold-chain transport and refrigeration of medicines is often difficult to achieve or maintain.” 

This addition to the EML follows the 2018 update to the WHO’s recommendations on uterotonics for the prevention of PPH. The guidelines recommend heat-stable carbetocin for the prevention of excessive bleeding after all births in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics. The CHAMPION trial, the largest clinical trial in PPH prevention, showed that heat-stable carbetocin is non-inferior to current standard of care oxytocin, for the primary outcome of ≥500 ml blood loss or additional uterotonic use, after vaginal birth. Heat-stable carbetocin remains effective at high temperatures, addressing a significant limitation of oxytocin, which must be stored and transported at 2 – 8°C.
Carbetocin is currently registered in more than 80 countries worldwide for the prevention of PPH due to uterine atony following caesarean section.The Dr. is now seeking registrations for heat-stable carbetocin for the prevention of PPH following all births. Once approved, the heat-stable formulation of carbetocin will be available at an affordable and sustainable price to publicly controlled or publicly funded healthcare facilities and healthcare facilities operating on a social marketing basis in low- and lower-middle income countries. 

About the EML
The WHO Model List of Essential Medicines (EML) serves as a guide for the development of national and institutional essential medicine lists and is updated and revised every two years by the WHO Expert Committee on Selection and Use of Medicines.

 

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