Risks of stomach bleeding increased by aspirin in over-75s

A recent study by researchers in Oxford in June this year suggested that taking aspirin daily may have led to higher incidences of bleeding in the over-75 age group.

BBC News reported that those in the over-75 age group taking daily aspirin as a precautionary measure after a stroke or heart attack were at a higher risk of stomach bleeds than had been previously conceived.

The Oxford Vascular Study was carried out by researchers from the University of Oxford and funded by the Wellcome Trust, Wolfson Foundation, British Heart Foundation, Dunhill Medical Trust, National Institute of Health Research (NIHR), and the NIHR Oxford Biomedical Research Centre.

The study aimed to assess the bleeding risk for people taking aspirin for the secondary prevention of cardiovascular events. In other words, the people in the research had already had a stroke or heart attack and were taking aspirin to try and prevent them having another. The follow-up period was for up to 10 years with the intention of seeing how many of them were admitted to hospital with bleeds.

Aspirin performs the function of a blood thinner and hence it is often given to people thought to be at risk from blood clots, which, if left unchecked, could trigger a heart attack or stroke. Unfortunately, a potential downside is that it can trigger bleeding in the digestive system or brain.

The researchers found that for under-75s taking aspirin, the annual risk of bleeding is around 1%. However, this risk factor is tripled for those over the age of 75. What was more disturbing was the bleeds were particularly associated with those of the stomach and upper digestive tract. 405 bleeding events required medical attention during the follow-up period, and of these, 187 of which were major bleeds. 40% of bleeds were in the upper digestive tract. The risk of disabling or fatal bleeding of the upper digestive tract was 10 times higher for over-75s compared with younger adults.

The findings of the research suggested that prescribing proton pump inhibitor (PPIs) could significantly reduce these risks in older adults. PPIs are drugs which help defend the lining of the stomach and the risk of a bleed is minimised.

Currently, the prescription of PPIs together with aspirin is not routine for over-75s. While PPIs can considerably reduce the risk of digestive bleeding for regular aspirin users, there are concerns over their side effects, which can include nausea and constipation.

The findings, however, only apply to people taking regular aspirin for secondary prevention of cardiovascular events, and cannot be directly applied to people for primary prevention (that is, people with risk factors for cardiovascular disease but who have not yet had an event such as a stroke or heart attack), or to people using aspirin for brief periods for example to treat pain or fever.

But it must be stressed that no-one should come off the pills quickly, or without consulting their doctor, as doing so would create an immediate risk of heart attacks.

Around 40 per cent of pensioners in the UK take aspirin daily. This estimate is also evenly split between those who have already suffered a heart attack or stroke, and those taking it as a precaution.

Prof Peter Rothwell, the lead author from the University of Oxford said aspirin was causing around 20,000 bleeds annually – and causing at least 3,000 deaths.

Prof Rothwell said: “We know clearly from trials and other research that aspirin is effective at preventing recurrent heart attacks and strokes. Twenty per cent of potential recurrent heart attacks and strokes are prevented by aspirin.

“Nevertheless, there are also about 3,000 excess bleeding deaths attributable to blood-thinners like aspirin across all age-groups,” he said, warning that the risk of serious bleeding is much higher among the over 75s.

“You would probably be advised to stop it in your late 60s or around 70 because at that point the risk of bleeding does start to take off – the risks may well outweigh the benefits,” he said.

Dr Tim Chico, consultant cardiologist, University of Sheffield, said the risks of aspirin were often understimated. “Although bleeding is a well-recognised side effect of aspirin, this drug is still seen by many people as harmless, perhaps because of how easily it can be bought over the counter, “ he said. “Prescription of any drug is a balance between the benefits of the medication against its risks, and aspirin is no different,” he said.

The need for cautious antibiotic usage

Antibiotics are medicines which are used to treat forms of bacterial infection or prevent their spread. As the name “antibiotics” suggest, they are anti-bodies and work by killing bacteria or preventing them from reproducing and spreading.

That all sounds impressive. But unfortunately antibodies don’t work for everything. For example, antibiotics don’t work for viral infections such as colds and flu, and most coughs and sore throats. Someone suffering from these infections usually get better without the use of antibiotics. The use of antibiotics to treat these is actually counter-productive, as taking antibiotics when you don’t need them encourages dangerous bacteria that live inside you to become resistant. Over time, this will mean that when you require the help of antibiotics most, they may not work for you as you may have actually been encouraging the tolerance of bacteria by suppressing your body’s ability to fight bacteria.

So don’t use antibiotics for common ailments that can get better on their own. In these situations, what you need is pain relief, and there are many options to choose from. However, antibiotics may be used to treat bacterial infections in cases such as when bacteria could infect others unless treated or infections are not likely to clear up without antibiotics. In other words, if there is further risk of infection to others, or complications which may arise from a lack of treatment, then a course of antibiotics is best followed.

The doses of antibiotics vary but if you are prescribed a course, then take the antibiotics as directed on the packet or the patient information leaflet that comes with the medication. If in doubt then seek advice from the pharmacist.

Antibiotics can be administered in various ways. The most common antibiotics are oral ones, in the form of capsules, tablets or liquid. These are commonly used to treat moderate infections or infections which are milder. There are also topical antibiotics, which are basically creams, lotions, sprays or drops, which are often administered for skin infections.

Topical and oral antibiotics are for less-serious infections. More serious infections, where the medicine has to be absorbed more quickly into the bloodstream, have to be treated by antibiotics administered through injection or drip infusion.

It is essential to finish taking a prescribed course of antibiotics, even if you feel better before the course has ended The prescribed doseage is the estimated time it will take to completely kill off the bacteria. Midway through a course, you may have killed off enough bacteria to not be under the effect of the infection, but stopping the course of antibiotics then can leave the remaining bacteria become resistant to the antibiotic.

But what if you missing a dose of antibiotics? If that is the case, then it is advisable to take that dose as soon as you remember and then continue to take your course of antibiotics as normal. However, if you have missed a dose and only remembered it when it is nearly time for the next dose, it is preferable to simply skip it and merely to continue your regular dosing schedule. Taking two doses only encourages the body to anticipate needing the double doseage in order to fight the infection, and messes up the body’s resistance levels.

Furthermore, there is a higher risk of side effects if you take two doses closer together than recommended. You may experience effects such as pain in your stomach, diarrhoea, and feeling or being sick. Most side effects are gastro-intestinal, and overdosing on anti-biotics may cause bloating, indigestion and diarrhoea.

Some people may have an allergic reaction to antibiotics, especially penicillin and a type called cephalosporins. In very rare cases, this can lead to a serious allergic reaction (anaphylaxis), which is a medical emergency. Sufferers carry an epi-pen and the drug is administered in the bloodstream through injection.

Antibiotics are not over the counter medicines and you should never use any remaining tablets arising from someonbe else’s incomplete course, as you may experience different reactions to the drug. Some antibiotics are also not suitable for people with certain medical conditions, or women who are pregnant or breastfeeding, as they may, for example, adversely affect the lining of the stomach. You should only ever take antibiotics prescribed for you and also never pass them on to someone else.

Antibiotics are only still chemicals and depending on the constituents, some can also react unpredictably with other medications, such as the oral contraceptive pill and alcohol. It’s important to read the information leaflet that comes with your medication carefully and discuss any concerns with your pharmacist or GP.

There are hundreds of different types of antibiotics, but most of them can be broadly classified into six groups. These are outlined below.

Penicillins (such as penicillin and amoxicillin) – widely used to treat a variety of infections, including skin infections, chest infections and urinary tract infections

Cephalosporins (such as cephalexin) – used to treat a wide range of infections, but some are also effective for treating more serious infections, such as septicaemia and meningitis

Aminoglycosides (such as gentamicin and tobramycin) – tend to only be used in hospital to treat very serious illnesses such as septicaemia, as they can cause serious side effects, including hearing loss and kidney damage; they’re usually given by injection, but may be given as drops for some ear or eye infections

Tetracyclines (such as tetracycline and doxycycline)– can be used to treat a wide range of infections, but are commonly used to treat moderate to severe acne and rosacea

Macrolides (such as erythromycin and clarithromycin) – can be particularly useful for treating lung and chest infections, or an alternative for people with a penicillin allergy, or to treat penicillin-resistant strains of bacteria

Fluoroquinolones (such as ciprofloxacin and levofloxacin) – broad-spectrum antibiotics that can be used to treat a wide range of infections

The use of antibiotics especially for conditions that aren’t serious has led to a rise in the number of high-tolerant infections, or superbugs. These superbugs and have a high tolerance to many anti-bodies and include:

methicillin-resistant Staphylococcus aureus (MRSA)
Clostridium difficile (C. diff)
the bacteria that cause multi-drug-resistant tuberculosis (MDR-TB)
carbapenemase-producing Enterobacteriaceae (CPE)

Ridding the world of these types of infections can be challenging, and these superbugs are becoming an increasing cause of disability and death across the world. The biggest worry is that new strains of bacteria may emerge with higher levels of resistance and that can’t be effectively treated by any existing antibiotics, so we have to be wary in how we use them, and when we suffer from minor infections, let the body try to fight off the infection instead of relying on antibiotics which may weaken the body’s immunity in the long run.

Drugs and Side Effects

All drugs come with side effects, whether they be common off-the-counter medicines or ones that require specialist prescription. Most of these effects can be minor, and some can just be an inconvenience – like having to go to the toilet more often than usual. But a few are serious, and some can just have unforeseen effects that address other ailments.

The most common set of side effects for drugs taken internally involves the gastrointestinal system. Because all prescription drugs invariably end up broken down in the stomach, nearly any drug can cause nausea or an upset stomach. The chances of these happening are quite rare, though for the handful of users this happens too the results can be quite upsetting. For drugs used externally, skin irritation is a common complaint. Which leads me to wonder – if you are merely replacing one symptom with another, is medicine merely an elimination of an ill-effect by replacement through increasingly minor symptoms, until they are bearable?

Side effects fall into several categories. The most common allergic reactions can happen with any drug and can range from itching and rash, which cause flaring on the skin and trigger even more itching and rash. They can be serious all the way up to a life-threatening anaphylactic reaction.

So if drugs have side effects, why not just get rid of these effects in the course of construction? Surely the likes of Glaxo Smith Kline, with their huge companies and research budget, can afford to genetically alter the drugs and lower the side effects? Some drugs can’t help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (more commonly known by the brand name Benadryl). It eases allergy symptoms but in the course of doing so, it also suppresses the activity of the body chemical acetylcholine. The side effect it causes is drowsiness and a host of other side effects, including dry mouth. It seems like to minimise allergies, it makes you fall asleep. Surely any fool could do that? Want to stop scratching? Go to bed!

Some drugs typically have barely noticeable side effects when dosed properly. The side effects can be minimal externally but internally they can be quite serious. For example, Warfarin (also known as Coumadin or marketed as Jantoven), is used to prevent blood clots, and while it is usually well tolerated, it can cause serious internal bleeding. I suppose it is like cancer, or heavy consumption of alcohol.

And while side effects may exist within the drug itself, further complications may also occur when certain drugs are mixed with certain other things. If you are mixing different types of drugs together, the combined chemical properties might cause complications. I suppose this is why my mother used to say never take Neurofen and Paracetamol within hours of each other. These might also be considered drug interactions. Drinking alcohol with narcotic painkillers has also caused an alarming increase in accidental overdose deaths. What??? Again, part of me wonders whether it isthe interactions of these chemicals that induced these, or whether it was because drinkers thought they had taken drugs to counter the effects like headaches, and then proceeded to consume more than they would normally have. Drinking grapefruit juice can affect the blood levels of several drugs, including some blood pressure and cholesterol medicines. Citrus fruits tend not to mix well with other foods, although vodka and orange seem a common mix?

Information about drugs legally has to be made available on the label of over-the-counter drug products and on package inserts or printed materials included with the packaging. Usually on the outer box you will find the concise version of all the drug does, and the inserts include the longer version. Because this could be potentially be a long list of possible bad effects, and written in a technical style, it is very helpful to also talk to pharmacists or doctors if you have any queries regarding a drug’s side effects.

Drugs are sometimes prescribed to young children – the more common examples are for hyperactivity, although depression prescriptions are becoming increasingly common, even for children under the age of ten. In the case of hyperactivity, for example, we should always be mindful of simply prescribing medication because it may be that the behaviour is a response to the demands of the task. In the case of depression, it may be that the individual is overwhelmed by demands, and coping strategies, rather than medication, may provide better help. Drugs should be carefully considered because one of the long term side effects is addiction and resistance to medication.

In America, before a drug is released on the market it must be approved by the FDA. Pharmaceutical companies typically submitted New Drug Applications (NDAs) which contain the pre-requisite clinical evidence demonstrating that the drug has the therapeutic effect it is supposed to have. The NDA must also contain proof that the drug is safe for human use. Unfortunately this proof comes from testing of the drug, first in animals and then in humans. Is it fair that rabbits and rats should suffer for the human race, in cages, doused with experimental acids to see if they develop irritations or severe symptoms? I guess you have to decide for yourself where you stand on that.

Homeopathic remedies may still be a long way away before they can be relied wholly on as a cure, but the day where herbal or plant-based remedies replace animal-treated alternatives is one we can look forward to. Once the basic questions of safety are settled, the FDA will approve the drug if it deems that the benefits outweigh its risks.

Sometimes not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. The pool of human testers is fairly small, so until a large data sample of users is obtained the side effects are not wholly known. MedWatch, the FDA’s post-marketing surveillance program seeks voluntary input, mainly from health care professionals, on adverse effects they may be seeing in ”the real world”. Sometimes these reports are numerous and serious enough for the FDA to take regulatory action, either through the addition of warnings to a drug’s label. One example of that involves the psoriasis drug Raptiva. The FDA required that the drug carry the agency’s strongest warning, known as a black box warning, after reports of brain infections and meningitis in patients taking the drug were received. The side effects were deemed so dangerous that the drug was later withdrawn from the market. Did the testers not recognise this when the lab mice died?

In soliciting feedback, the FDA also wants input from consumers using the various prescription drugs. All prescription drugs must be labelled with a toll-free number maintained by the agency for the purpose of reporting side effects with drugs. The FDA labels these “adverse events.” Severe side-effects can be reported through calling MedWatch at 1-800-FDA-1088 or through the FDA web site: www.­fda.­gov/­Safety/­MedWatch/­HowToReport/­default.­htm.

As we have seen earlier, the post-marketing information coming in to the FDA is so disturbing that it results in a drug coming off the market. Another case can be seen with the drug Baycol, which lowers cholesterol, after it was strongly linked to a potentially fatal breakdown of muscle tissue. While it had been initially approved in 1997, it was voluntarily withdrawn just four years later when evidence of its side effects was published. The anti-inflammatory drug Duract spent just one year on the market. It had been approved as a product strictly for short-term use, but the FDA found serious liver problems with people taking the drug for longer than what was recommended. Which begs the question: “Who is responsible for regulating patients’ consumption of medicines?” While they are safety guards in place, such as some drugs available only on prescription, what is to stop patients obtaining multiple prescriptions?

That aside, drug companies are also required to report adverse events to the FDA, and failure to do so can lead to prosecution. In 1985, two drug companies were fined and sentenced to community service for not reporting adverse events involving the blood pressure drug Selacryn and arthritis drug Oraflex. Both products were pulled from the market.

In the UK, licenses can only be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

The stages through which potential medicines are first thoroughly researched start first with the use of tissue culture, followed by computer analysis techniques and finally animal testing.

Likewise, if strict standards of safety and effectiveness are met, clinical trials involving humans can then be used. The license for wider use is approved only if a medicine passes all the phases of clinical trials.

The whole process from discovery to licensing can take a long time, around 10 to 15 years, which means pharmaceutical labs work under a cloak of secrecy and also explains why they may not be willing to withdraw a drug for its side effects if they have invested that much time and money in it.

Not every side effect is a bad one. Some are downright welcome. Take finasteride. Introduced in 1992 to treat noncancerous enlargement of the prostate gland, it was found to regrow hair (and is marketed for that purpose under the name Propecia). Patient: “Doctor, how’s my prostrate?” Doctor: “Under control, but a bit hairy.”

Today, millions of men use a low dose of finasteride to treat male pattern baldness. Minoxidil, originally marketed as an oral tablet for high blood pressure, was found to grow hair in those using it. Today, as a topical lotion or foam, it is a popular over-the-counter remedy for baldness. But can you imagine the doctor going “Your blood pressure is normal, Chewbacca”?