An inexpensive generic drug that saves the lives of wounded soldiers and civilian car crash victims has now been shown to rescue women suffering hemorrhages in childbirth.

Postpartum hemorrhage, in which women bleed uncontrollably after childbirth, kills an estimated 100,000 women a year in poor and middle-income countries. The 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.</s>A cheap and widely available drug could save the lives of thousands of women who die in childbirth from excessive bleeding, one of the main killers of women worldwide.

The drug, tranexamic acid, is available over the counter in the UK to women suffering from heavy periods. In Japan and the far east, it is used as a skin whitener. But now a very large study of 20,000 women in 21 countries has shown it can stop a third of cases of bleeding to death after giving birth.

Haemorrhage after childbirth kills 100,000 women a year, mostly in low and middle-income countries. “It is not only the women dying – it is the impact on the child that has to grow up without a mother, children who might already be in the family and the husband,” said associate professor Haleema Shakur from the London School of Hygiene & Tropical Medicine who led the trial.

“This is of absolutely huge importance. While a single mother is dying, we need to keep fighting for them.”

The drug has already been proven to cut the death toll from bleeding after accidents in a trial of similar size. The latest trial, published in the Lancet medical journal, recruited more than 20,000 women who either gave birth in one of 193 hospitals involved or managed to get there after starting to bleed. They were randomly assigned either tranexamic acid or a placebo.

The researchers found that tranexamic acid was most effective when it was given soon after the bleeding began. The trial was originally intended also to find out whether the drug saved women from having to undergo a hysterectomy – the removal of the womb. But the scientists discovered that in many countries, where anaemia is common and blood supplies are limited, surgeons operated immediately as the surest way to save the woman’s life.

If all women who haemorrhage after childbirth were given the drug, the trial suggests that 30,000 lives could be saved a year. In practice, that will be more difficult. Tranexamic acid was given in an intravenous injection in the hospitals, as the quickest way to have an effect. Many women give birth at home and may not get to a hospital in time.

“It is available in the form of a tablet for heavy periods, but absorption may take too long,” said Shakur. They are now working on new ways to get it rapidly into women’s systems – perhaps as an injection in the arm muscle or as a capsule under the tongue. It is also possible that women deemed to be at high risk of haemorrhage could be given a tablet before they give birth. The trials have shown no side-effects, making the drug very safe.

Of the two-thirds of women who died in spite of being given the drug, Shakur said some arrived at hospital too late, while others had underlying illness including severe malaria and anaemia which may have been the cause of death.

It has taken a long time to show that the drug does work in the context it was designed for. Professor Ian Roberts from the London School, who co-led the study, said: “The researchers who invented tranexamic acid more than 50 years ago hoped it would reduce deaths from postpartum haemorrhage, but they couldn’t persuade obstetricians at the time to conduct a trial. Now we finally have these results that we hope can help save women’s lives around the world.”



There are many next steps, said Shakur. “We have to make sure tranexamic acid is available wherever a woman gives birth and is at risk,” she said. “We must make sure doctors and midwives are aware of the results of the study. And we need health ministers to make sure that the drug is available in their country and is on their shopping list of essential medicines.”</s>Back in the 1960s, a woman doctor in Japan created a powerful drug to help mothers who hemorrhage after childbirth.

The medicine is inexpensive to make. Safe to use. And stops bleeding quickly by helping keep naturally forming blood clots intact.

The drug's inventor, Utako Okamoto, hoped the drug called tranexamic acid would be used to help save moms' lives.

Every year about 100,000 women around the world die of blood loss soon after a baby is born. It's the biggest cause of maternal death worldwide.

"It was Okamoto's dream to save women," says Haleema Shakur, who directs clinical trials at London School of Tropical Medicine and Hygiene. "But she couldn't convince doctors to test the drug on postpartum hemorrhaging."

And so tranexamic acid has gone largely unused in maternity wards for decades.

In a massive international trial, Shakur and her collaborators have shown that tranexamic acid decreased the risk of death from blood loss associated with childbirth by about a third. (Previous studies have looked at the drug's use in reducing bleeding deaths after traumatic injuries.)

In the study, women who were diagnosed with heavy bleeding, or postpartum hemorrhage, after a vaginal birth or cesarean section received either the drug or a placebo.

About 1.2 percent of women who got tranexamic acid within three hours of a hemorrhage died, compared with 1.7 percent of the women who got the placebo.

Side effects weren't a serious problem. The medicine didn't increase the risk of dying of other causes during the procedure, Shakur and her colleagues report in The Lancet journal.

The study included 20,000 women, in nearly 200 hospitals, across 21 countries, including rich ones, like the U.K., and poorer ones, like Pakistan and Nigeria.

The medicine is inexpensive. It cost about $3 in the U.K., and a quarter of that in Pakistan, for instance.

"If you can save a life for approximately $3, then I believe that's worth doing," Shakur says.

It's rare to have a new tool for helping women during childbirth, says Felicia Lester, an OB-GYN at the University of California, San Francisco, who also works in Uganda and Kenya.

"I think the study is exciting," she says. "I'm usually cautious in saying that. But it looks like tranexamic acid has the potential to save lives."

The drug even helped women when doctors used it along with other common medications, such as oxytocin, says Margaret Kruk, a global health researcher at Harvard University.

"Tranexamic acid offers an additional benefit above and beyond what is being done for women already," she says.

Now, though, the big question is how to make sure this drug is available for women who need it the most — women in the poor, remote areas of the world, where maternal mortality is the highest.

"That's, I think, the million dollar question," Kruk says. "We in global health have a number of tools that seem very effective in large clinical trials. But then when it comes time to use them for all women, we see very large gaps in implementation."



Now promising news for moms-to-be around the world. Doctors say they have found a drug that prevents deaths during childbirth. It could save tens of thousands of lives each year, especially in poor countries. NPR's Michaeleen Doucleff reports.

MICHAELEEN DOUCLEFF, BYLINE: Every two minutes, a woman around the world dies in childbirth. There are many reasons why, but the most common is blood loss. Dr. Rizwana Chaudhri is an OB-GYN in Pakistan. She tells The Lancet Journal that women bleed to death every day in clinics there.

RIZWANA CHAUDHRI: You can't even think of that in the developed world. But over here, this is an everyday thing, which goes on and on and on.

DOUCLEFF: For decades, doctors have known about a drug that could possibly help. It's inexpensive and widely available, but it hadn't been tested thoroughly. So an international team of doctors put together a massive study with 20,000 women across 21 countries.

Dr. Haleema Shakur at the London School of Hygiene and Tropical Medicine helped lead the trial. She tells The Lancet Journal, where the results appear, that after 10 years of work, they finally have very good news.

DOUCLEFF: The drug called Tranexamic acid was shown to be safe for women. When it's given quickly after childbirth, it reduces the risk of bleeding to death by a third.

SHAKUR: We've shown it to be effective, that it can save lives. And I hope every single doctor who sees a woman with postpartum hemorrhage makes sure he or she considers using Tranexamic acid in that woman they're seeing.

DOUCLEFF: Many researchers praised the study. Felicia Lester is an OB-GYN at the University of California, San Francisco who also works in Uganda and Kenya. She says having a new way to help women during childbirth is quite rare.

FELICIA LESTER: I think it's exciting, actually, and I am usually cautious to say that kind of thing. But it has the potential to save lives.

DOUCLEFF: But she says there's still a huge challenge with this drug and that's getting it to the women who need it the most, those who live in poor remote corners of the world. Michaeleen Doucleff, NPR news. Transcript provided by NPR, Copyright NPR.</s>Overlooked Drug Could Save Thousands Of Moms After Childbirth

Back in the 1960s, a woman doctor in Japan created a powerful drug to help mothers who hemorrhage after childbirth.

The medicine is inexpensive to make. Safe to use. And stops bleeding quickly by helping keep naturally forming blood clots intact.

The drug's inventor, Utako Okamoto, hoped the drug called tranexamic acid would be used to help save moms' lives.

Every year about 100,000 women around the world die of blood loss soon after a baby is born. It's the biggest cause of maternal death worldwide.

"It was Okamoto's dream to save women," says Haleema Shakur, who directs clinical trials at London School of Tropical Medicine and Hygiene. "But she couldn't convince doctors to test the drug on postpartum hemorrhaging."

And so tranexamic acid has gone largely unused in maternity wards for decades.

In a massive international trial, Shakur and her collaborators have shown that tranexamic acid decreased the risk of death from blood loss associated with childbirth by about a third. (Previous studies have looked at the drug's use in reducing bleeding deaths after traumatic injuries.)

In the study, women who were diagnosed with heavy bleeding, or postpartum hemorrhage, after a vaginal birth or cesarean section received either the drug or a placebo.

About 1.2 percent of women who got tranexamic acid within three hours of a hemorrhage died, compared with 1.7 percent of the women who got the placebo.

Side effects weren't a serious problem. The medicine didn't increase the risk of dying of other causes during the procedure, Shakur and her colleagues report in The Lancet journal.

The study included 20,000 women, in nearly 200 hospitals, across 21 countries, including rich ones, like the U.K., and poorer ones, like Pakistan and Nigeria.

The medicine is inexpensive. It cost about $3 in the U.K., and a quarter of that in Pakistan, for instance.

"If you can save a life for approximately $3, then I believe that's worth doing," Shakur says.

It's rare to have a new tool for helping women during childbirth, says Felicia Lester, an OB-GYN at the University of California, San Francisco, who also works in Uganda and Kenya.

"I think the study is exciting," she says. "I'm usually cautious in saying that. But it looks like tranexamic acid has the potential to save lives."

The drug even helped women when doctors used it along with other common medications, such as oxytocin, says Margaret Kruk, a global health researcher at Harvard University.

"Tranexamic acid offers an additional benefit above and beyond what is being done for women already," she says.

Now, though, the big question is how to make sure this drug is available for women who need it the most — women in the poor, remote areas of the world, where maternal mortality is the highest.

"That's, I think, the million dollar question," Kruk says. "We in global health have a number of tools that seem very effective in large clinical trials. But then when it comes time to use them for all women, we see very large gaps in implementation."</s>A cheap and widely available drug could save the lives of 1 in 3 of the 100,000 new mothers who bleed to death after childbirth every year, mostly in poorer countries, according to the first study of its use in postpartum hemorrhage.

In a trial of 20,000 women, researchers found that the drug, called tranexamic acid (TXA), cut the number of deaths due to postpartum bleeding by 31 percent if it was given within three hours. The treatment costs about $2.50 in most countries, they said.

As TXA works by stopping blood clots from breaking down, the researchers also found that it reduced the need for urgent surgery to control bleeding by more than a third.

TXA, which is now an off-patent generic medicine, was originally invented in the 1960s by a Japanese husband-and-wife research team, Shosuke and Utako Okamoto. The drug is widely used to treat excessive blood loss from major trauma injuries.

“It’s safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth,” said Haleema Shakur, an associate professor at the London School of Hygiene & Tropical Medicine who co-led the trial.

The study involved mothers from 193 hospitals in 21 countries, mainly in Africa and Asia but also in Britain and elsewhere, who suffered postpartum hemorrhage, the leading cause of maternal death worldwide.

PPH is defined as a blood loss of more than 500 milliliters within 24 hours of giving birth.

The results showed that of the women given tranexamic acid within three hours, 89 died from bleeding compared with 127 given the normal standard care plus a placebo. No side effects from the drug were found for either mothers or babies.

They had hoped it would be used to reduce deaths from PPH, but according to the LSHTM experts who ran this study, they were unable to persuade obstetricians at the time to conduct a trial.</s>Trial of 20,000 women shows deaths from heavy bleeding after giving birth reduced by 30 percent with tranexamic acid.

Heavy bleeding after giving birth is the leading cause of maternal deaths worldwide, killing more than 100,000 women each year.

Around six percent of women suffer from postpartum hemorrhaging (PPH) - uncontrollable bleeding after giving birth.

In many cases, the lack of access to basic healthcare and medication is the difference between life and death.

But there is new evidence that a low-cost drug could save a third of those lives.

A trial involving 20,000 women in 193 hospitals across 21 countries - mainly in Africa and Asia - found that a widely available drug called tranexamic acid (TXA) could help save lives.

Within three hours of birth, women diagnosed with PPH were either given TXA or a placebo intravenously.

READ MORE: Why Sri Lanka beats India in maternal mortality ratios

Those who took the medicine - which stops bloodclots from breaking down - were significantly more likely to survive.

"We now have important evidence that the early use of tranexamic acid can save women's lives and ensure more children grow up with a mother," said Haleema Shakur of the London School of Hygiene and Tropical Medicine, which coordinated the trial.

"The need for an operation where you explore why a woman is bleeding can be reduced by a third and there are no side effects. It's really fantastic news for women all over the world."

TXA was invented in the 1960s by a Japanese husband-and-wife research team, Shosuke and Utako Okamoto.

According to the study published in The Lancet, almost all of the deaths from PPH took place in low-and middle-income countries.

"Mothers [in Pakistan] are faced with poverty and our social norms also don't encourage us to visit hospitals or doctors for regular checkups," Sajida Begum, a resident of Sher Garh Mardan in Pakistan's Khyber Pakhtunkhwa province told Al Jazeera.</s>A drug that costs just £3 could slash the risk of death by a third among mothers who suffer major bleeding after childbirth.

The cheap drug, called tranexamic acid or TXA, is only currently used as a last resort for women who suffer a major haemorrhage soon after giving birth.

But experts have called for the medicine to be become the 'frontline' treatment for post-partum haemorrhage, after a major international trial found it reduced deaths by 31 per cent.

Using the drug within three hours of a bleed also reduced the need for major surgery by 36 per cent, the team at the London School of Hygiene and Tropical Medicine found.

Every year 35,000 women in England and Wales suffer a haemorrhage after labour - one in 20 of all births.

The vast majority of these are resolved safely, but 13 or 14 times a year women die as a result, making it the third leading direct cause of maternal death in the country.

In many more cases women undergo major surgery to stop the bleeding, and in extreme cases doctors perform a hysterectomy to save the mother's life, removing their womb and spelling an end to their chances of having more children.

The new study, published last night in the Lancet medical journal, found that many of these tragedies could be avoided if women were given TXA as soon as possible.

The trial of 20,000 women - 500 of them in the UK - found no side effects from the drug for either mothers or babies.

Study leader Dr Haleema Shakur, associate professor of clinical trials at the London School of Hygiene & Tropical Medicine, said: 'We now have important evidence that the early use of tranexamic acid can save women's lives and ensure more children grow up with a mother.

Tranexamic acid was invented in the 1960s by a Japanese husband and wife research team, Shosuke and Utako Okamoto. But the drug, which works by stopping blood clots from breaking down, was neglected for decades because the inventors could not persuade a company to fund a major trial. In recent years, however, experts have rediscovered the drug's potential. A major trial of its use for trauma patients in 2010, also led by the London team, found it had huge value in stopping emergency bleeding. Within two weeks of that study's publication, TXA was being used by the British Army in Afghanistan, and it has now been adopted by UK ambulance services for roadside accidents. Its use in childbirth emergencies, however, has been slow to catch up. Part of the reason for this is the World Health Organisation only recommends it after all other treatments have failed.

'It's safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth.'

Dr Shakur said: 'That's too late - it has to be given as early as possible. We would like to see it used as a frontline treatment. At the moment it is being used ad hoc and not according to any clear guidelines.'

She said the new trial - which was funded by the UK Department of Health, the Wellcome Trust and the Bill & Melinda Gates Foundation - provides the evidence for new guidance.

Dr Shakur said: 'It has taken 50 years to get to this position, it is out of patent, and nobody is going to make a lot of money from it, so it has taken funding mostly from British taxpayers to get here.'

Professor Ian Roberts, who co-led the study, added: 'Now we finally have these results that we hope can help save women's lives around the world.'

Professor Lesley Regan, president of the Royal College of Obstetricians and Gynaecologists, said: 'The results of this important trial are very welcome and show that early administration of a cheap, widely available and heat-stable drug can reduce the number of maternal deaths from excessive bleeding after childbirth.

'Although post-partum haemorrhage is rare in the UK, there hasn't been a significant reduction in the number of deaths from the condition since 2009.'

The Royal College of Obstetricians and Gynaecologists, which sets guidance for British doctors, recommends that doctors ‘consider’ use of TXA.

But a spokesman for the college last night said: ‘We will now review our guidance in light of the study findings and make any appropriate changes.’</s>A low-cost and widely available drug could save the lives of 1 in 3 mothers who would otherwise bleed to death after childbirth, according to a new study.

Severe bleeding, known as postpartum hemorrhage, or PPH, is the leading cause of maternal death worldwide, killing more than 100,000 women every year. Even for mothers who survive, it is a painful and traumatic experience.

The world's poorest countries, especially in Africa and India, are the worst hit.

But there is new hope. In the 1960s, Japanese researchers developed a drug called tranexamic acid, which works by stopping blood clots from breaking down. But they could not persuade doctors to try the drug for treating PPH.

The London School of Hygiene and Tropical Medicine has done just that, in a trial involving 20,000 women in 21 countries, mainly in Africa and Asia. The results show tranexamic acid reduces the risk of bleeding to death by almost a third, with no side effects for either mothers or babies.

Dr. Nike Bello, a consultant obstetrician and gynecologist in Nigeria, said that "if a drug can prevent hysterectomies, a drug can prevent death, a drug can minimize the amount of blood we need, then that is a good thing, all over the world."

But there are challenges to getting the drug where it is needed. First, the doctors must know about its effectiveness, said professor Ian Roberts of the London tropical medicine school, who led the latest research.

"We want everyone to hear about the results," he said. "But then there are the nitty-gritty issues. Is the treatment available in the hospital? Do doctors and midwives know how to use it? It is heat stable, so it does not have to be kept in the fridge. It is relatively inexpensive — it is about a dollar. And no child should grow up without a mother for lack of a treatment that costs a dollar."

In the trial, tranexamic acid was given via a drip. Researchers say the next step is to find an easier way to administer the drug so it can be used in clinics and rural settings across the world.</s>One of the most heart-wrenching public health problems facing the world has been the large number of women who die during or after childbirth despite all our medical progress. Melinda Gates has called the issue one of her top priorities and committed more than $1.5 billion from her family's foundation to the cause. Countless scientists have explored the issue from every angle.

But could part of the solution be simpler than we imagined?

The results of a remarkable clinical trial released Wednesday in the journal Lancet suggest that a single injection of an old drug - and one that costs less than $1 a dose - may be able to save tens of thousands of those lives each year.

The study, conducted in 193 hospitals in 21 countries, involved 20,000 women who were undergoing one of the most life-threatening medical complications: postpartum hemorrhage. Giving birth takes a brutal toll on a woman's body, and many things can go wrong along the way - a tear in the vagina or birth canal, a rupture of the cervix, a placenta that is stuck to the womb and doesn't separate properly. In some cases, women experience a coagulation problem in which there is no obvious injury but there is uncontrollable bleeding. This bleeding is the leading cause of maternal mortality around the world. An estimated 14 million women experience postpartum hemorrhage, and more than 100,000 die from it.

In the study, known as the WOMAN (or World Maternal Antifibrinolytic) Trial, patients were randomized to receive either a placebo or tranexamic acid (TXA), which helps the blood to clot. The treatment, given intravenously, was used alongside other actions that emergency doctors would normally take to try to stop such bleeding. The trial was double-blind, meaning neither the doctors and researchers nor the patients knew what they got.

In analyzing the outcomes of the women, the research team, co-led by the London School of Hygiene and Tropical Medicine's Ian Roberts, found that the risk of death from bleeding was reduced by 20 percent for the women who got tranexamic compared with those who got nothing. If the medicine was given quickly, within three hours of the start of bleeding, the results were even more promising - with a 30 percent reduction in the risk of death.

TXA was discovered more than 50 years ago by a Japanese doctor, Utako Okamoto, but TXA's value wasn't recognized until relatively recently. In 2010, another large trial - known as CRASH-2 - that involved victims of traffic accidents, shootings and land mines who were bleeding out showed that TXA could reduce the risk of death in those trauma patients by 15 percent.

Paramedics in some countries carry the injection, and the World Health Organization has added it to its list of essential medicines that should be available to everyone and that form the basis of national drug policy in countries across the world.

Roberts, who also worked on the trauma trial, said TXA's under-appreciation for so long underscores how the global system of pharmaceutical discovery and development is broken. If it wasn't for Gates and other donors like the Wellcome Trust getting involved and funding the postpartum-bleeding trial, it may have never gotten off the ground.

"There has been a market failure with this drug for a long time," Roberts said. "We didn't reap its humanitarian benefit because there was no sort of financial incentive to do so."

Wellcome Trust senior partner Tim Knott said the trial "stands to make a critical difference in preventing women dying after childbirth."

Not only is TXA cheap, it doesn't need to be refrigerated, making it easy to transport and store. The main drawback, Roberts said, is that many women in the developing world give birth in remote areas assisted only by a midwife or someone else who may not be trained to give an IV injection. He said the researchers' next step is to look at formulations of TXA that can have a similar effect but can be given in pill or other form so someone with little training can administer it.

The WHO recommends that TXA be given if other efforts to control bleeding fail, but Roberts said the study suggests that the timeline for the drug be accelerated, especially in developing countries, so that doctors give it as soon as the bleeding begins.

"The trial data show women die really soon after onset," he said. "If a woman has a postpartum hemorrhage in Washington, D.C., the hospital will likely have a lot of blood in the blood bank and lots of tools to keep a woman stable while they try one thing and then another. But in Africa, a woman can die within the hour or certainly within that day if the bleeding is not controlled."
Results, published in The Lancet medical journal, of the WOMAN (World Maternal Antifibrinolytic) international study that began in 2010, finds use of a cheap and widely available drug, tranexamic acid (Lysteda in the U.S. and Australia), could save the lives of thousands of women who die in childbirth from excessive bleeding. The medication is already in use for blood loss from major trauma, surgery, tooth removal, nose bleeds, and heavy menstruation.