Patients may be dying because watchdog is not approving dental antibiotics
Patients with heart problems are dying needlessly every year because they are not being given antibiotics when they visit the dentist, doctors have said.
Almost 400,000 people in the UK are at high risk of developing life-threatening infective endocarditis any time they have dental treatment, they said. The condition kills 30 per cent of sufferers within a year.
A refusal to approve antibiotic prophylaxis (AP) in such cases means that up to 261 people a year are getting the disease and up to 78 dying from it, they added. That policy may have caused up to 2,010 deaths over the last 16 years, it is claimed.
Reintroduction of AP for high-risk individuals undergoing invasive dental procedures would not only save lives, it would also result in significant savings for the National Health Service
The doctors say the danger has arisen because the National Institute for Health and Care Excellence (NICE) does not follow international good medical practice and tell dentists to give at-risk patients antibiotics before they have a tooth extracted, root canal treatment or scale removed.
The doctors – who include a professor of dentistry, two leading cardiologists and a professor of infectious diseases – have outlined their concerns in The Lancet medical journal. In it, they urge NICE to rethink its approach in order to save lives, citing pivotal evidence that has emerged since the regulator last examined the issue in 2015, which shows that antibiotics are “safe, cost-effective and efficacious”.
Their concerns were reported today by The Guardian newspaper.
The paper described how infective endocarditis (IE) is an infection of the heart’s inner lining and the valves that separate each of the heart’s four chambers. In about 30 to 40 per cent of cases it is caused by bacteria in the mouth getting into the bloodstream as a result of poor oral hygiene or invasive dental treatment. The bacteria can then inflame damaged heart valves and also artificial heart valves.
An estimated 397,000 Britons are at risk of developing the condition as a direct result of undergoing dental treatment because they have had a congenital heart condition or have previously been treated for a cardiac condition, for example by having a pacemaker or ventricular assist device implanted.
Patients are being put in danger because NICE’s position is at odds with the European Society of Cardiology and the American Heart Association, both of which say high-risk patients should receive antibiotics before dental treatment, the doctors allege.
The medicines regulator used to support that approach, said The Guardian. But in 2008 it changed its position and said that that should stop because there was too little evidence and it had concerns about possible side-effects, such as the risk of fatal anaphylaxis, outweighed the potential benefits.
In the joint opinion article in the Lancet Regional Health – Europe, the doctors say that switch led to “a significant increase in IE incidence”. An extra 35 people a month get IE as a result of it, according to evidence the Lancet published in 2015.
Data showing the number of dental procedures in which antibiotics would need to be given in order to prevent one case of IE “suggest that 41-261 cases (including 12-78 deaths) could be prevented annually in the UK”. Switching to dentists routinely administering antibiotics to high-risk patients when they treat them would be cost-effective for the NHS even if it prevented just 1.4 cases of IE a year, they state.
The doctors say: “Therefore, the reintroduction of AP for high-risk individuals undergoing invasive dental procedures would not only prevent serious disease and save lives, it would also result in significant savings for the UK National Health Service.”
NICE’s switch in 2008 to opposing antibiotics may have led to as many as 6,700 extra cases of IE and 2,010 deaths from it during the 16 subsequent years, according to Martin Thornhill, a co-author of the paper and professor of translational research in dentistry at Sheffield University.
His co-authors include Prof Bernard Prendergast, a consultant cardiologist at Guy’s and St Thomas’ NHS trust in London, Ireland-based consultant cardiologist Mark Dayer, and Larry Baddour, a professor on infectious diseases at the Mayo Clinic hospital in the US.
Unusually, noted The Guardian, the paper was also co-written by a patient advocate, Ash Frisby. Her husband, Myles, was at high risk of IE because he had had a prosthetic heart valve fitted, when he underwent dental scaling – without receiving antibiotics – in October 2014. He developed IE soon after and died two months later, in December 2014. His symptoms were initially mistaken for flu.
Thornhill said: “By the time the diagnosis was made, the damage to the heart valves was so severe that he died soon after admission to hospital and diagnosis of IE.
“In most other countries, where antibiotic prophylaxis is recommended for high-risk patients undergoing invasive dental procedures, Myles would likely have been prescribed AP cover for the dental scaling and this would likely have prevented him from developing IE.”
Baddour said: “We have concerns that there are high-risk individuals in the UK who are at risk of infective endocarditis related to invasive dental procedures without antibiotic prophylaxis. We believe a re-evaluation of [NICE’s] position is needed in high-risk individuals undergoing invasive dental procedures, who should receive antibiotic prophylaxis.”
Prendergast said that, although NICE had softened its guidance slightly in 2015, it had “failed to react to accumulating evidence supporting the use of antibiotic prophylaxis in patients at high risk of IE undergoing specific high-risk procedures, including invasive dental procedures”.
NICE’s position has “created significant confusion” among both doctors and dentists treating high-risk patients as to whether to administer antibiotics or not, he added.
The drugs watchdog dismissed the doctors’ concerns. “Nice rejects the claim that patients are being harmed as a result of our guideline”, a spokesperson said. “The guideline says that antibiotic prophylaxis against infective endocarditis is not routinely recommended for people undergoing dental procedures. However, healthcare professionals should use their clinical judgment when implementing recommendations, taking into account the individual’s circumstances, needs and preferences.
“Our surveillance team is due to review the current evidence relating to prophylaxis against infective endocarditis this year and will determine whether any new information, studies or research would support the case for a further update of existing Nice guidance.”