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The American Heart Association has released their first statement to provide guidance on avoiding drug-drug or drug-condition interactions for people with heart failure. The statement provides information about specific drugs and “natural” remedies and their consequences for heart failure patients.
Prof. Alan Boyd, President of the Faculty of Pharmaceutical Medicine, said:
“The potential side effects on the heart and the circulatory system of all the drugs listed in this article are already known and, for many of them, they have been known about for many years. This publication now pulls together all the information that is currently available about this issue in one place and it is a useful summary about the adverse effects of drugs relating to the heart that could potentially happen in patients with heart failure. This is particularly important since patients with heart failure, because of other health issues that they may have and/or of their age, are routinely taking several types of medicines on a daily basis. It is a guidance document that should serve as a helpful source of advice for all doctors and other healthcare professionals who have patients with heart failure under their care.”
Dr Tim Chico, Reader in Cardiovascular Medicine / consultant cardiologist, University of Sheffield, said:
“This scientific statement attempts to summarise the known evidence for which drugs might increase the risk of developing or worsening heart failure. Many of these drugs are well known to cause heart failure, particularly chemotherapy drugs used to treat common and life-threatening cancers. In these cases use of these drugs is still appropriate, although increasingly we are recognising that patients treated with certain drugs should be monitored by a cardiologist both during and after treatment.
“We have known for some time that NSAIDs have the potential to increase the chance of heart problems, including heart attack and heart failure. It is important not to overestimate this risk; NSAIDs increase the risk of heart failure by only around 1.1 times. However, this statement reinforces the need to understand the reasons for why any drug is prescribed, and the benefits and drawbacks of any treatment.
“I strongly advise any patient worried by this advice not to stop any medication immediately, but to discuss their concerns with their GP or specialist first. Patients must not be reluctant to ask questions about their medications. The decision to start or continue a drug should be shared between the doctor and patient based on a clear and open conversation about any risks and benefits.”
Prof. Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
Is this statement based on good quality research?
“The strength of evidence for many of the drugs is rather weak. Many of the associations from observational data may be explained by the patients who are treated with the drugs of interest being at higher risks of heart failure for reasons other than the drugs they are given. For many drugs, the effects are based on randomised trials and the possibility of false-positive findings is markedly reduced.
Are the conclusions in the statement backed up by solid data?
“They all have data as far as I can tell, but some of the data is not as certain as the authors imply.
Did we already know about these potential adverse effects / interactions for the drugs listed?
“As far as I can tell, all of these adverse effects were known before. This paper and guideline brings together data that were scattered across many other places. In most instances (I have not had time to check them all), there are warnings of these effects in the product information available to prescribers and patients.
How does this statement fit with the existing evidence?
“Generally it reflects current beliefs.
Are all these drugs used commonly in the UK?
“The great majority of these drugs (again I have not checked them all in detail so it may be all of them) are used in the UK.
Have the authors accounted for confounders? Are there important limitations to be aware of?
“The authors do not seem to have done original research on these drugs generally, but they have relied on original investigators to deal with confounders. In some instances, the adjustments made may have been inadequate.
What are the implications in the real world?
“Doctors do need to be aware of the potential for adverse effects of many medicines, and also of the potential for interactions, even with common medicines.
“In most instances doctors will have correctly assessed the benefit/harm balance for an individual patient, but with people taking a large number of drugs this can be very difficult.
Should people stop taking their medications?
“People should never be advised to stop their medicines on the basis of what is here; they should consult their doctor, or at least their pharmacist if they have concerns. In many instances the effects are not large and they are not described in terms of their magnitude in many cases – rates are absent from Table 1. “Major” refers to the type of adverse event that is affected, not how large the effect is for an individual.
Does this mean NSAIDs like ibuprofen can cause heart failure?
“NSAIDs can contribute to heart failure and this knowledge of the cardiac effects of NSAIDs has been shown previously in a large meta-analysis published in The Lancet in 20131.”
1 [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778977/]
Coxib and traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769-779.
Prof. Peter Weissberg, Medical Director, British Heart Foundation, said:
“This statement provides a timely reminder that many drugs, whether prescribed or purchased over the counter, can have adverse effects on patients with heart failure. The examples of drug interactions quoted are well known to the medical community, but the danger comes when these patients self-medicate, either with over-the-counter medications, or with nutritional supplements and herbs.
“The message is that patients with heart failure should always consult a doctor before taking any new product with medicinal claims, and doctors need to remain conscious of known drug interactions when prescribing drugs for their patients.”
Prof. Tony Fox, Professor of Pharmaceutical Medicine, King’s College London, said:
“Today’s American Heart Association statement on drugs, herbals and heart failure draws attention to the importance and complexity of these drugs and this disease. The drugs that the statement mentions are also commonly used in the UK and the rest of Europe.
“Heart failure almost never occurs as a single disease. The trade-offs and interplay between drugs, heart failure, and its complications requires regular review when treating a patient. For example, in someone who has arthritis as well as heart failure, is it worth trying a dose of ibuprofen (an over the counter pain killer) that could cause a small amount of fluid retention, but which may improve the patient’s physical activity, and will that ability to exercise help overall?
“Sodium (salt) is generally bad for patients with heart failure. The amounts that can be taken, and also avoided, in food are huge. These amounts in food are generally much bigger than those found in tablets. Once again, a small amount of sodium in a tablet has always to be weighed against the benefit that the tablet may create.
“The warnings about ‘herbal’ medicines, almost all of which are not medicine at all, are especially good. With rare exceptions, we know little about the toxicity of these unregulated products, and there is next-to-no evidence for any benefit, either. Ephedra, in particular, is a well-known poison in patients both with and without heart disease because of its effects on blood pressure. Goldenseal, St John’s wort and other herbal materials interfere with the patient’s enzymes that handle other drugs. This can cause an overdose even though the patient is still correctly taking exactly the same number of tablets as was prescribed. Just because it is ‘herbal’ does not automatically mean it is safe, and not just in heart failure, either. Even Shakespeare knew about that: Romeo and Juliet die after taking a herbal poison.
“While heart failure patients should not be alarmed, this statement emphasises a few common sense things. 1. Make sure your doctor knows about ALL of the drugs that you take INCLUDING all herbal remedies. 2. Do not start taking some new drug or herbal medicine without checking with your doctor first. 3. Be alert for mild adverse effects, and tell your doctor about them BEFORE they get any worse. 4. Check with your doctor before you stop taking a drug that has been prescribed. 5. NEVER change the dose that you have been prescribed (in particular, it is wrong to believe that if one tablet does you good then two will make you feel even better).”
Prof. Sir Munir Pirmohamed, David Weatherall Chair of Medicine, University of Liverpool, and Vice President Clinical, British Pharmacological Society, said:
“The AHA has published a very thorough analysis of drugs that can either cause or exacerbate heart failure. This is an important document which provides up-to-date information in this clinically significant area in one place. This is not new evidence but a synthesis of evidence that is already available in the literature, and is based on sound pharmacological principles.
“There are of course many different mechanisms and many different drugs involved, and prescribing in susceptible individuals should take into account the age of the patient, any other comorbidities and other drugs that the patient is taking.
“As with any other area, the key issues are (a) to use the lowest dose of the drug for the shortest period of time; (b) to be aware of the potential for the drug to cause or exacerbate heart failure and monitor patients for the occurrence of new symptoms of heart failure; (c) to get a thorough drug history before patients are started on any new drugs, including a history of herbal medications to minimise drug-drug interactions; and (d) to ensure that patients do not stop drugs of their own accord, but always consult with their doctor about the drugs they are taking and any associated adverse effects.
“As our population demographics change, with an aging population, we need to be especially aware of the potential for drug-drug interactions and drug-disease interactions which can lead to heart failure. Further research in this area will be important to ensure that we can identify these complex interactions in a timely manner in the future.”
Dr Gavin Sandercock, Reader in Clinical Physiology (Cardiology) and Director of Research, University of Essex, University of Essex, said:
“There is nothing in this paper to suggest NSAIDs ‘cause’ heart failure and only some rather weak evidence that they may make symptoms worse in people who already have heart failure. All the evidence comes from observational studies (as there have been no trials) and none of the studies mentioned show a significant risk in healthy individuals.
“Most of the drugs which seem to cause real problems are prescription only, and none of the herbal or over-the-counter medicines listed are anywhere near as dangerous as the ‘polypharmacy’ of prescription drugs.
“The report doesn’t say patients should not be taking herbal or over-the-counter drugs – but it does say these should not be used to treat heart failure.
“Nowhere does it say that any over-the-counter or herbal remedies can cause heart failure in otherwise healthy individuals.
“It does say that people with heart failure should list what they are taking and tell their doctor – which is sensible advice.
“The report is not really written for patients; certainly not for the general population but it provides excellent advice for doctors.”
‘Drugs that may cause or exacerbate heart failure; a scientific statement from the American Heart Association’ by Robert L. Page et al. published in Circulation on Monday 11 July 2016.
Declared interests
Prof. Alan Boyd: “paid employment or self-employment – Director of Boyd Consultants which helps Universities and small companies develop their research ideas into medicines for use in patients.
Dr Tim Chico: “I am a committee member and Treasurer of the British Atherosclerosis Society, a charity established in 1999 to promote UK atherosclerosis research.”
Prof. Stephen Evans: “I have no financial interests to declare. I sit on the EU Drug Safety Committee (PRAC) at the European medicines Agency.”
Prof. Peter Weissberg: “No interests to declare.”
Dr Gavin Sandercock: “No conflicts of interest to declare.”
No others received.