Already known to save lives of wounded soldiers and civilian car crash victims, an inexpensive generic drug has now found to rescue women suffering hemorrhages in childbirth.
Postpartum hemorrhage happens when women bleed uncontrollably after childbirth and it kills an estimated 100,000 women a year in poor and middle-income countries. Its complication also forces doctors to perform emergency hysterectomies, especially when hospitals have too little blood on hand to provide transfusions.
In a major six-year trial involving over 20,000 women in 21 countries, researchers showed that tranexamic acid, a little-known blood-clotter invented in the 1950s, reduced maternal bleeding deaths by a third if it was given within three hours. It costs less than $2 a dose and does not require refrigeration.
The trial — known as Woman, short for World Maternal Antifibrinolytic — was led by doctors at the London School of Hygiene and Tropical Medicine and paid for by the Wellcome Trust, Pfizer, Britain’s health department and the Bill and Melinda Gates Foundation. Results were published in The Lancet on Wednesday.
“Tranexamic acid can save women’s lives and ensure more children grow up with a mother,” said Haleema Shakur, one of the lead authors.
The World Health Organization currently recommends treating birth hemorrhages by massaging the uterus and injecting uterus-shrinking drugs like oxytocin.
Tranexamic acid acts in a different way — it allows blood to clot more quickly — and so it should be given in addition to the usual measures and at the same time, said Dr. Ian Roberts, one of the study’s lead authors.
“Women die very quickly from this, especially in Africa, because they are so profoundly anemic,” Dr. Roberts said. “Half the women giving birth there start off with roughly half the red blood cells they should have. If you or I had hemoglobin counts that low, we’d be breathless.”
“Doctors are forced to throw in everything they’ve got, because they know the woman can be dead in an hour,” he added.
Emergency hysterectomies save some lives, but the women will never bear another child. It is “logical to infer” that such operations would also be reduced if tranexamic acid becomes widely available in delivery rooms, Dr. Roberts said.
The drug was invented in Japan by a husband-wife research team, Shosuke and Utako Okamoto. They hoped it would be used to prevent birth hemorrhages, but local obstetricians declined to organize a clinical trial.
Ultimately, they turned the patent over to a Japanese pharmaceutical company, which sold it as treatment for heavy menstrual periods and as an ingredient in skin-whitening creams. Some oral surgeons used it when doing dental work on hemophiliacs, Dr. Roberts said.
(Released with the new study was a video interview Dr. Roberts conducted with 98-year-old Utako Okamoto just before her death last year.)
Suspecting that tranexamic acid could also stop major bleeding like that caused by car crashes or bullet wounds, he eventually received British government funding to do a trial in 20,000 emergency-room patients in 40 countries.
The results, published in the Lancet in 2010, showed that the drug lowered hemorrhage death rates by 30 percent.
The British military was so impressed that it started stocking tranexamic acid in surgical units in Iraq, and American military surgeons followed suit. The W.H.O. added it to a list of essential drugs that all hospitals should have on hand.
Nonetheless, civilian trauma surgeons were slow to adopt tranexamic acid, in part, Dr. Roberts said, because no major drug company conducted a publicity campaign for it. So he did his own, including a movie of a claymation figure bleeding to death and a manga cartoon book about an emergency-room doctor stabbed at work.
Now, he said, he will focus on seeing whether the drug, which is given intravenously, can be delivered more easily in rural clinics through intramuscular shot or even a pill under the tongue.
Dr. Jerker Liljestrand, a maternal health specialist at the Gates Foundation, said the organization will work with the W.H.O. and local governments to make sure tranexamic acid becomes part of the recommended treatment for post-partum bleeding.
Source: The New York Times