WHO clinical trial finds oxytocin’s alternative
While Oxytocin, must be stored and transported at 2–8 degrees Celsius, and becomes less effective when exposed to heat, Carbetocin does not require refrigeration
New Delhi: The World Health Organization (WHO) has come up with a safe and effective alternative to the controversial drug oxytocin.
After considering the results of its clinical trials on a new formulation, carbetocin, WHO has asked the Guideline Development Group to consider if the new drug should be recommended for the prevention of postpartum haemorrhage instead of oxytocin. At present, WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth.
Carbetocin could save thousands of women in low- and lower-middle-income countries, WHO said on Thursday. While Oxytocin, must be stored and transported at 2–8 degrees Celsius, and becomes less effective when exposed to heat, Carbetocin does not require refrigeration and retains its efficacy for at least three years even if it is stored at 30 degrees Celsius, and in 75% relative humidity.
“The development of a drug to prevent postpartum haemorrhage that continues to remain effective in hot and humid conditions is very good news for the millions of women who give birth in parts of the world without access to reliable refrigeration,” said Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO.
The clinical trial led by WHO in collaboration with MSD, also known as Merck & Co, for Mothers and Ferring Pharmaceuticals, studied close to 30,000 women who gave birth vaginally across 10 countries, including Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK.
The results of the study have also been published in the New England Journal of Medicine, showing the alternative drug – heat-stable carbetocin – to be as safe and effective as oxytocin in preventing postpartum haemorrhage.
During the trial, each woman was randomly given a single injection of either heat-stable carbetocin or oxytocin immediately following the birth of her baby. The study found that both drugs were equally effective at preventing excessive bleeding after birth. Since both drugs in the study were kept at the temperatures required to ensure maximum efficacy of oxytocin, the trial may underestimate the benefit expected with heat-stable carbetocin use in real-life settings, where oxytocin may degrade due to exposure to higher temperatures, the WHO said in an official release.
Approximately 70,000 women die every year because of postpartum haemorrhage – increasing the risk that their babies also die within one month.
In India oxytocin is misused by diary owners for more milk. Considering the problem, the Ministry of Health and Family Welfare has restricted the manufacture of Oxytocin formulations for domestic use to public sector only from 1st July 2018. It has also banned the import of Oxytocin and its formulations. From 1st July 2018, no private manufacturer will be allowed to manufacture the drug for domestic use.