Evidence map›Paper›PMID 32067255›Full record

ArticleBritish journal of clinical pharmacology2020

Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab.

Alice Fabbri, Mary O'Keeffe, Ray Moynihan, Mathias Møllebaek, Annim Mohammad, Alice Bhasale, Lorri Puil, Barbara Mintzes

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Alice FabbriCharles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-8413-0440
Mary O'KeeffeInstitute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Ray MoynihanInstitute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.
Mathias MøllebaekCopenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
Annim MohammadCharles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Alice BhasaleCharles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Lorri PuilDepartment of Anaesthesiology, Pharmacology, and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Barbara MintzesCharles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
The University of Sydney · AUBond University · AUUniversity of British Columbia · CAUniversity of Copenhagen · DK

Funding

CIHR PJT‐153275National Health and Medical Research Council of Australia APP 1122332
6 · The paper itself

Abstract

aimsDrug regulators issue safety advisories to warn clinicians and the public about new evidence of harmful effects of medicines. It is unclear how often these messages are covered by the media. Our aim was to analyse the extent of media coverage of two medicines that were subject to safety advisories from 2007 to 2016 in Australia, Canada, the United Kingdom and the United States.

methodsTwo medicines widely used to treat mental health or physical conditions were selected: citalopram and denosumab. Media reports were identified by searching LexisNexis and Factiva. Reports were included if they stated at least one health benefit or harm. A content analysis of the reports was conducted.

resultsIn total, 195 media reports on citalopram and 239 on denosumab were included. For citalopram, 43.1% (84/195) of the reports mentioned benefits, 85.6% (167/195) mentioned harms and 9.7% (19/195) mentioned the harm described in the advisories (cardiac arrhythmia). For denosumab, 94.1% (225/239) of the reports mentioned benefits and 39.7% (95/239) mentioned harms. The harms described in the advisories were rarely mentioned: 10.9% (26/239) of the reports mentioned osteonecrosis and ≤5% mentioned any of the other harms (atypical fractures, hypocalcaemia, serious infections and dermatologic reactions).

conclusionsWe found limited media coverage of the harms highlighted in safety advisories. Almost two-thirds of the media stories on denosumab did not include any information about harms, despite the many advisories during this time frame. Citalopram coverage covered harms more often but rarely mentioned cardiac arrhythmias. These findings raise questions about how to better ensure that regulatory risk communications reach the general public.

Indexed as

CitalopramPharmaceutical PreparationsAustraliaCanadaDenosumabHumansUnited KingdomUnited StatesCitalopramDenosumabPharmaceutical Preparationsclinical pharmacologydrug informationmedication safetypublic health

Identifiers

PMID32067255
PMCPMC7319008
OpenAlexW3008985683

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.