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

• Published in: British journal of clinical pharmacology Vol. 86; no. 7; pp. 1416 - 1429
• Main Authors: Fabbri, Alice, O'Keeffe, Mary, Moynihan, Ray, Møllebæk, Mathias, Mohammad, Annim, Bhasale, Alice, Puil, Lorri, Mintzes, Barbara
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.07.2020
• Subjects: clinical pharmacology; drug information; medication safety; Original; public health; clinical pharmacology; medication safety; drug information; public health
• ISSN: 0306-5251; 1365-2125; 1365-2125
• DOI: 10.1111/bcp.14255

Aims Drug 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. Methods Two 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. Results In 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). Conclusions We 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.