Why are hospitals ignoring a drug that can stop patients bleeding to death?
Tranexamic can reduce bleeding and the need for blood transfusions during surgery, according to research
One of the greatest risks of surgery is blood loss. There is a cheap drug which dramatically reduces the risk of haemorrhaging, but experts say it’s being ignored by British doctors, putting the thousands of patients who have an op every year in unnecessary danger.
Why? The drug is out of patent, meaning pharmaceutical companies aren’t interested in making it widely available, because they won’t make money from it.
The medicine, called tranexamic acid, is sold over the counter under the brand names Cyklo-F and Femstrual to help women affected by heavy periods.
But research has shown injections of the drug can also reduce bleeding and the need for blood transfusions during surgery — and it can also help stop victims of traffic accidents and other serious injuries from bleeding to death, with no serious side-effects.
It’s even used by the British and U.S. military, but experts such as Ian Roberts, professor of epidemiology at the London School of Hygiene and Tropical Medicine, say our operating theatres and accident and emergency departments are lagging behind on this key development.
‘We have known this drug reduces bleeding in surgery for over a decade now,’ says Prof Roberts. ‘There is research which shows it reduces the need for blood transfusions by about a third in all types of operations. But it is still not being widely used.’
Tranexamic acid works by helping the blood to clot — it stops fibrinolysis, a natural process that breaks down blood clots in the body. When there is a risk of excessive bleeding, tranexamic acid can be a lifesaver.
An injectable form of the drug is made by Pfizer for use in some conditions associated with excessive bleeding such as prostate surgery and tooth extractions in people with haemophilia. But what baffles the experts is why it isn’t given routinely in surgery. In June 2010, a large international trial run in 40 countries including the UK and involving 20,000 patients found that the drug could be used successfully to save the lives of trauma victims — badly injured patients with serious bleeding, for example from road accidents or stabbings.
The trial, widely known as the CRASH-2 trial, published in the Lancet, showed the drug could lower the risk of trauma victims bleeding to death by up to 30 per cent.
Since the trial, the drug has been introduced on to the battlefield by the military to help save the lives of badly injured soldiers. But according to Tim Coats, professor of emergency medicine at the University of Leicester, it is still not being widely used in NHS hospitals to save the lives of civilians.
He says: ‘Hospitals are stocking it but they are not using it.’ In 2011, fewer than one in ten trauma patients who were bleeding heavily were given the drugs, adds Professor Coats, who estimates that in the UK the drug could save the lives of 150 victims of serious injury annually.
In addition, an extensive review of research published in the BMJ this year found that the drug could also reduce the risk of bleeding in patients having any type of surgery, including common operations such as hip replacements.
The review, which included 129 trials covering more than 10,000 patients, found it reduced the need for blood transfusions in surgical patients by one third.
‘In some types of common surgery the risk of haemorrhage is quite high — for example, hip replacement patients have a high chance of needing a blood transfusion,’ says Professor Roberts. ‘If I were a surgical patient I would want to have tranexamic acid because it reduces the risk of haemorrhage so you’re less likely to need a blood transfusion, which can itself have complications.’
While every effort is made to make blood transfusions safe, Professor Roberts points out they can still have adverse effects including serious allergic reactions (such as breathlessness and vomiting) to substances in the blood, heart failure from fluid overload, an abnormal immune response resulting in shortness of breath, fever and sometimes shock, and infections from contaminated blood.
Using tranexamic acid routinely in surgery would help avoid these risks, says Professor Roberts. ‘All patients undergoing surgery should be offered this drug. Using it could also save the NHS about £25 million annually.’
The problem is tranexamic acid is not licensed for use in trauma patients or for most types of surgery, meaning it has to be used ‘off-label’ — without a licence — in these areas.
In addition, it is out of patent, so extending its use to trauma victims and all patients having surgery would not be sufficiently profitable for the drugs industry, says Professor Roberts.
‘Getting a drug licensed for a condition is a decision that can only be taken by the companies that make it. They are unlikely to do this because they will not make much money from it.
‘Being out of patent means that anyone can make this drug, so there’s less money to be made. There’s not a huge financial incentive to market it.
‘Everyone knows it’s effective in trauma patients and you would think it would be offered to all surgical patients, but the system doesn’t work like that.
‘I find it quite shocking that it takes so long to get something into practice, at the cost of tens of thousands of lives worldwide. Moreover, while tranexamic acid is being used off-label in some areas, many surgeons are unaware of its benefits,’ he adds. ‘This drug is safer than a blood transfusion.’
Mike Murphy, professor of blood transfusion medicine at the University of Oxford, said he too was ‘absolutely convinced’ the drug should be used in surgery.
In June, Professor Roberts wrote to the then Health Secretary, Andrew Lansley, pointing out the benefits of tranexamic acid and urging him to take action.
‘Mr Lansley replied that he had asked the government watchdog, NICE, to make tranexamic acid the first drug to be assessed under a new programme looking at unlicensed uses of drugs.