Literature DB >> 29181699

Benefits, benefits, once more benefits... with no risk? Stop overlooking the harms of medicines.

Silvio Garattini1, Vittorio Bertele'2.   

Abstract

Consideration of drug benefits and harms is asymmetric. Approval of drugs is mainly based on efficacy, while the assessment of their safety is left to post-marketing commitments or spontaneous reporting. Benefits are overestimated as a result of pharmaceutical companies' advertisements, the paucity of independent information, and the scant understanding of the effectiveness of medicines in real life. Polypharmacy in older adults-even during the last period of their life-reflects the tendency to assign priority to efficacy and overlook harms, although nobody knows what happens when three or more drugs are given chronically. Medical journals and public research funding projects do not pay enough attention to drug toxicity. We call for a sense of purpose by all those involved in medicine to tackle this problem. European and national agencies and health authorities should promote and support independent information and experimental and clinical studies on drug toxicity. Information should rely not just on spontaneous reporting but also on active pharmacovigilance. The benefit-harm profile of drugs should be periodically reviewed in the light of toxic effects that come to light over the years. Potential interactions within polytherapies should be sought by re-assessing the pharmacokinetics and pharmacodynamics of their components.

Entities:  

Keywords:  Benefit; Drug toxicity; Effectiveness; Harm; Polypharmacy; Risk

Mesh:

Year:  2017        PMID: 29181699     DOI: 10.1007/s00228-017-2378-0

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  11 in total

1.  Approvals of drugs with uncertain benefit-risk profiles in Europe.

Authors:  Rita Banzi; Chiara Gerardi; Vittorio Bertele'; Silvio Garattini
Journal:  Eur J Intern Med       Date:  2015-09-03       Impact factor: 4.487

2.  Drug-drug interactions in a cohort of hospitalized elderly patients.

Authors:  Luca Pasina; Codjo D Djade; Alessandro Nobili; Mauro Tettamanti; Carlotta Franchi; Francesco Salerno; Salvatore Corrao; Alessandra Marengoni; Alfonso Iorio; Maura Marcucci; Piermannuccio Mannucci
Journal:  Pharmacoepidemiol Drug Saf       Date:  2013-08-30       Impact factor: 2.890

3.  Polypharmacy, length of hospital stay, and in-hospital mortality among elderly patients in internal medicine wards. The REPOSI study.

Authors:  Alessandro Nobili; Giuseppe Licata; Francesco Salerno; Luca Pasina; Mauro Tettamanti; Carlotta Franchi; Luigi De Vittorio; Alessandra Marengoni; Salvatore Corrao; Alfonso Iorio; Maura Marcucci; Pier Mannuccio Mannucci
Journal:  Eur J Clin Pharmacol       Date:  2011-01-11       Impact factor: 2.953

Review 4.  Hospital admissions due to adverse drug reactions in the elderly. A meta-analysis.

Authors:  T J Oscanoa; F Lizaraso; Alfonso Carvajal
Journal:  Eur J Clin Pharmacol       Date:  2017-03-01       Impact factor: 2.953

Review 5.  Letting post-marketing bridge the evidence gap: the case of orphan drugs.

Authors:  Roberta Joppi; Chiara Gerardi; Vittorio Bertele'; Silvio Garattini
Journal:  BMJ       Date:  2016-06-22

6.  The inverse benefit law: how drug marketing undermines patient safety and public health.

Authors:  Howard Brody; Donald W Light
Journal:  Am J Public Health       Date:  2011-01-13       Impact factor: 9.308

7.  Choosing Wisely? Measuring the Burden of Medications in Older Adults near the End of Life: Nationwide, Longitudinal Cohort Study.

Authors:  Lucas Morin; Davide L Vetrano; Debora Rizzuto; Amaia Calderón-Larrañaga; Johan Fastbom; Kristina Johnell
Journal:  Am J Med       Date:  2017-04-25       Impact factor: 4.965

8.  Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Authors:  Marc S Sabatine; Robert P Giugliano; Anthony C Keech; Narimon Honarpour; Stephen D Wiviott; Sabina A Murphy; Julia F Kuder; Huei Wang; Thomas Liu; Scott M Wasserman; Peter S Sever; Terje R Pedersen
Journal:  N Engl J Med       Date:  2017-03-17       Impact factor: 91.245

9.  Collaborative overview of randomised trials of antiplatelet therapy--I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration.

Authors: 
Journal:  BMJ       Date:  1994-01-08

Review 10.  Predicting the clinical relevance of drug interactions from pre-approval studies.

Authors:  Silvio Caccia; Silvio Garattini; Luca Pasina; Alessandro Nobili
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

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  1 in total

Review 1.  Patient harm from cardiovascular medications.

Authors:  Chariclia Paradissis; Neil Cottrell; Ian Coombes; Ian Scott; William Wang; Michael Barras
Journal:  Ther Adv Drug Saf       Date:  2021-07-25
  1 in total

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