Drugs to Avoid in 2017

OUTLOOK 2017 Update A more recent version is available online at english.prescrire.org Use the “Search” function with keywords “drugs to avoid (Prescrire's annual review)” Towards better patient care: drugs to avoid in 2017 ABSTRACT harm-benefit balance, and the trial design must be relevant. Tailored supportive care is the best ● To help healthcare professionals and patients option when there are no available treatments choose high-quality treatments that minimise the capable of improving prognosis or quality of life, risk of adverse effects, in early 2017 we updated beyond their placebo effect. the list of drugs that Prescrire advises health pro- Rev Prescrire 2017; 37 (400): 137-148 fessionals and patients to avoid. ● Prescrire’s assessments of the harm-benefit balance of new drugs and indications are based on a his is Prescrire’s fifth consecutive annual rigorous procedure that includes a systematic and review of “drugs to avoid” (1,2). The drugs reproducible literature search, identification of Tlisted here are clearly more dangerous than patient-relevant outcomes, prioritisation of the sup- beneficial and should therefore not be used. The porting data based on the strength of evidence, aim is to help health professionals choose safe, comparison with standard treatments, and an anal- effective treatments and thereby avoid harming ysis of both known and potential adverse effects. their patients. ● This fifth annual review of drugs to avoid has been extended to cover all drugs examined by A reliable, rigorous and independent Prescr ire between 2010 and 2016 and authorised methodology in the European Union, whereas previous reviews only considered drugs marketed in France. We What data sources and methodology do we use to identified 91 drugs that are more harmful than assess the harm-benefit balance of a given drug? beneficial in all the indications for which they have The following review concerns drugs and indica- been authorised in France or in the Europe- tions on which we published detailed analyses in an Union. our French edition over a seven-year period, from 2010 to 2016. Some drugs and indications were ● In most cases, when drug therapy is really examined for the first time, while others were ne cessary, other drugs with a better harm-benefit re-evaluated as new data on efficacy or adverse balance are available. effects became available. All our publications are intended to provide ● Even in serious situations, when no effective health professionals (and thereby their patients) treatment exists, there is no justification for pre- with the clear, independent, reliable and up-to-date scribing a drug with no proven efficacy that pro- information they need, free from conflicts of inter- vokes severe adverse effects. It may be acceptable est and commercial pressures. to test these drugs in clinical trials, but patients Prescrire is structured in such a way as to guar- must be informed of the uncertainty over their antee the quality of the information provided to our PRESCRIRE INTERNATIONAL • APRIL 2017 • VOLUME 26 N° 181 • PAGE 108-1 Downloaded from english.prescrire.org on 02/10/2021 Copyright(c)Prescrire. For personal use only. OUTLOOK subscribers. The Editorial Staff comprise a broad example, it can be difficult to attribute a specific range of health professionals working in various outcome to a particular drug, as other factors must sectors and free from conflicts of interest. We also be taken into account, including the natural history call on an extensive network of external reviewers of the disease, the placebo effect, the effect of an- (specialists, methodologists, and practitioners rep- other treatment the patient may not have men- resentative of our readership), and each article tioned, or a change in lifestyle or diet. Similarly, a undergoes multiple quality controls and doctor who sees an improvement in certain patients cross-checking at each step of the editorial process may be unaware that many other patients have been (see About Prescrire > How we work at english. harmed by the same treatment (3). prescrire.org). Our editorial process is a collective The best way to overcome this subjective bias one, as symbolised by the “©Prescrire” signature. due to non-comparative evaluation of a few pa- Prescrire is also fiercely independent. Our work tients is to prioritise well-conducted clinical studies, is funded solely and entirely by our subscribers. No particularly double-blind randomised trials versus company, professional organisation, insurance sys- standard care (3,4). tem, government agency or health authority has any financial influence whatsoever over the content Serious conditions with no effective treat- of our publications. ment: patients should be informed of the conse quences of interventions. When faced Comparison with standard treatments. The with a serious condition for which there is no effective harm-benefit balance of a given drug has to be con- treatment, some patients opt to forgo treatment while tinually re-evaluated as new data on efficacy or ad- others are willing to try any drug that might bring verse effects become available. Likewise, treatment them even temporary relief, despite a risk of serious options evolve as new drugs arrive on the market. adverse effects. Not all drugs are equal: some offer a therapeutic When the short-term prognosis is poor, some advantage, while others are more harmful than health professionals may propose “last-chance” beneficial and should not be used (3). treatments without fully informing the patient of All Prescrire’s assessments of new drugs and the harms, either intentionally or unwittingly. indications are based on a systematic and repro- Yet patients in this situation must not be treated ducible literature search. The resulting data are then as guinea pigs. It is very useful to enrol patients analysed collectively by our editorial staff, using an into clinical studies provided they are informed of established procedure: the harms and the uncertain nature of the possible – Efficacydata are prioritised: most weight is given benefits, and that the results are published in order to studies providing robust supporting evidence, to advance medical knowledge. i.e. well-conducted, double-blind, randomised con- But patients must be made aware that they have trolled trials; the option of refusing to participate in clinical trials or – The new drug is compared with a carefully cho- to receive last-chance treatments with an uncertain sen standard treatment, if one exists (not necessar- harm-benefit balance. They must also be reassured ily a drug); that, if they do refuse, they will not be abandoned but – The accent is placed on those clinical endpoints will continue to receive the best available care. Even most relevant to the patients concerned. This means though they are not aimed at modifying the outcome that we often ignore surrogate endpoints such as of the underlying disease, supportive care and symp- simple laboratory markers that have not been shown tomatic treatment are key elements of patient care. to correlate with a favourable clinical outcome (4,5). By their very nature, clinical trials involve a high degree of uncertainty. In contrast, drugs used for Careful analysis of adverse effects. Adverse routine care must have an acceptable harm-benefit effects can be more difficult to analyse, as they are balance. Marketing authorisation should only be often less thoroughly documented than efficacy, granted on the basis of proven efficacy relative to and this discrepancy must be taken into account. standard care, and an acceptable adverse effect The adverse effect profile of each drug is as- profile: in general, little, if any, extra information on sessed by examining data from clinical trials and efficacy is collected once marketing authorisation animal pharmacotoxicology studies, and any has been granted (3). pharma cological affiliation. The fact that a new drug has been granted market ing authorisation does not signify that its 91 authorised drugs more dangerous harm-benefit balancehas been fully documented. than beneficial Indeed, rare but serious adverse effects may only emerge after several years of routine use (3). This review lists drugs that have an unfavourable harm-benefit balance in all their authorised indica- Empirical data and personal experience: risk tions, in other words drugs that should be removed of bias. Empirical assessment of a drug’s harm- from the market on account of their toxicity. Drugs benefit balance based on individual experience can with an unfavourable harm-benefit balance in help to guide further research but is subject to major certain situations but not in others have not been bias and represents only weak evidence (3,4). For included. PRESCRIRE INTERNATIONAL • APRIL 2017 • VOLUME 26 N° 181 • PAGE 108-2 Downloaded from english.prescrire.org on 02/10/2021 Copyright(c)Prescrire. For personal use only. OUTLOOK Notable changes in the 2017 update nly one drug from the list of drugs that Prescrire ad - Six of the new products examined by Prescrire in 2016 Ovises health professionals and patients to avoid was have an unfavourable harm-benefit balance in all their withdrawn from the market in 2016: the recombinant urate approved indications, and three of them are cancer drugs: oxidase pegloticase. Its European marketing authorisation, nintedanib for non-small cell lung cancer and for idiopath- for severe gout, was withdrawn at the request of the phar- ic pulmonary fibrosis,olaparib for ovarian cancer, pano- maceutical company concerned (Prescrire Int n° 180). binostat for multiple myeloma, mepolizumab for asthma, ciclosporin eye drops for dry eye disease, and idebenone Panitumumab, varenicline: Prescrire reviewing new for Leber’s hereditary optic neuropathy. data in 2017. The only drugs listed in our 2016 review of drugs to avoid that do not feature in this year’s review are Additions authorised at European level but not market- panitumumab for colorectal cancers and varenicline for ed in France.

Load more