Bahta, Merhawi http://orcid.org/0000-0002-1690-7876
Russom, Natnael http://orcid.org/0000-0002-4333-2932
Ghebrenegus, Amon Solomon http://orcid.org/0000-0002-1264-6285
Okubamichael, Yohana Tecleab
Russom, Mulugeta http://orcid.org/0000-0003-1939-5842
Article History
Accepted: 10 June 2024
First Online: 22 June 2024
Declarations
:
: Mulugeta Russom is an Editorial Board member of <i>Drugs - Real World Outcomes</i>, but was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The other authors declare that they have no competing interests.
: Information of all cases retrieved from the WHO global database of individual case safety reports is de-identified and ethics approval is not required.
: The datasets generated and analyzed during the current study are not publicly available due to agreements between contributors of data to the database used (VigiBase) and the custodian of the database. National Centers (mainly drug regulatory authorities) constituting the WHO Programme for International Drug Monitoring (PIDM) contribute data to VigiBase and the Uppsala Monitoring Centre is the custodian in its capacity as WHO Collaborating Centre for International Drug Monitoring. Some subsets of the data may be available from the corresponding author on reasonable request.
: The authors are indebted to the National Centers that make up the WHO Programme for International Drug Monitoring and contribute reports to VigiBase. However, the opinions and conclusions of this study are not necessarily those of the various Centers nor of the WHO or the Uppsala Monitoring Centre, Sweden. Readers should be aware that cases reported to VigiBase are of different quality and merely represent suspicious associations.
: MB and MR contributed to the conception and planning of the work described. All the authors contributed to the study design, analysis of publications, data analysis and their interpretation. MB and MR drafted the article, and it was reviewed by the rest of the authors. Finally, all authors read and approved the final manuscript and, therefore, share collective responsibility and accountability for the manuscript.
: There was no funding for this study.
: Not applicable.
: Not applicable.
: Not applicable.