Literature DB >> 24195018

Postmarketing adverse drug reactions: A duty to report?

Eran Klein1, Dennis Bourdette.   

Abstract

Physicians play an important role in recognizing and reporting suspected adverse drug reactions (ADRs) to the Food and Drug Administration (FDA). Physicians can report suspected ADRs directly to the FDA via its MedWatch program, by contacting the manufacturer of the drug, and by publishing case reports. While this takes time, physicians have an ethical obligation to participate in recognizing and reporting ADR.

Year:  2013        PMID： 24195018      PMCID： PMC3787113          DOI： 10.1212/CPJ.0b013e3182a1b9f0

Source DB:  PubMed          Journal:  Neurol Clin Pract        ISSN： 2163-0402


  8 in total

1.  Thrombotic thrombocytopenic purpura and clopidogrel--a need for new approaches to drug safety.

Authors:  A J Wood
Journal:  N Engl J Med       Date:  2000-06-15       Impact factor: 91.245

2.  Postmarketing surveillance of new antiepileptic drugs: the tribulations of trials.

Authors:  Jacqueline A French
Journal:  Epilepsia       Date:  2002-09       Impact factor: 5.864

Review 3.  The quality of published adverse drug event reports.

Authors:  William N Kelly
Journal:  Ann Pharmacother       Date:  2003-12       Impact factor: 3.154

Review 4.  Peer review and the process of publishing of adverse drug event reports.

Authors:  Steven B Karch
Journal:  J Forensic Leg Med       Date:  2007-02       Impact factor: 1.614

5.  150 years of pharmacovigilance.

Authors:  P Routledge
Journal:  Lancet       Date:  1998-04-18       Impact factor: 79.321

6.  Ethical considerations in studying drug safety--the Institute of Medicine report.

Authors:  Michelle M Mello; Steven N Goodman; Ruth R Faden
Journal:  N Engl J Med       Date:  2012-08-22       Impact factor: 91.245

7.  Delayed fingolimod-associated asystole.

Authors:  Patricio S Espinosa; Joseph R Berger
Journal:  Mult Scler       Date:  2011-06-07       Impact factor: 6.312

Review 8.  Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs.

Authors:  Lise Aagaard; Ebba Holme Hansen
Journal:  BMC Clin Pharmacol       Date:  2009-03-03
  8 in total
  8 in total

1.  The role of drug profiles as similarity metrics: applications to repurposing, adverse effects detection and drug-drug interactions.

Authors:  Santiago Vilar; George Hripcsak
Journal:  Brief Bioinform       Date:  2017-07-01       Impact factor: 11.622

2.  Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance.

Authors:  Manfred Hauben; Eric Y Hung
Journal:  Ther Adv Drug Saf       Date:  2016-05-23

3.  Postmarketing adverse drug reactions: A duty to report?

Authors:  Khichar Shubhakaran; Rekha Jakur Khichar
Journal:  Neurol Clin Pract       Date:  2014-02

4.  The value proposition of case reports: Novelty, pedagogy, anecdotal aggregation, humanity.

Authors: 
Journal:  Neurol Clin Pract       Date:  2014-12

5.  The US Food and Drug Administration, neurologists, and drug development and regulation.

Authors:  Gerald J Dal Pan
Journal:  Neurol Clin Pract       Date:  2015-08

6.  A decade of adverse drug events in Portuguese hospitals: space-time clustering and spatial variation in temporal trends.

Authors:  Gianina Scripcaru; Ceu Mateus; Carla Nunes
Journal:  BMC Pharmacol Toxicol       Date:  2017-05-10       Impact factor: 2.483

Review 7.  Molecular Docking: Shifting Paradigms in Drug Discovery.

Authors:  Luca Pinzi; Giulio Rastelli
Journal:  Int J Mol Sci       Date:  2019-09-04       Impact factor: 5.923

Review 8.  Pharmacovigilance: reporting requirements throughout a product's lifecycle.

Authors:  Sylvia Lucas; Jessica Ailani; Timothy R Smith; Ahmad Abdrabboh; Fei Xue; Marco S Navetta
Journal:  Ther Adv Drug Saf       Date:  2022-09-27
  8 in total

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