https://orcid.org/0000-0003-1509-3791
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B. Nardone, D.P. West, Reply to ‘Risk of malignancies associated with ustekinumab’, British Journal of Dermatology, Volume 178, Issue 1, 1 January 2018, Pages 296–297, https://doi.org/10.1111/bjd.16007
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Funding sources: none.
Conflicts of interest: none declared.
Dear Editor, In response to our recent article ‘Malignancies and ustekinumab: an analysis of the U.S. Food and Drug Administration Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database’,1 Greenspan et al.2 raise the issue about adding to the understanding of the drug safety profile, underscoring the need for robust evidence in determination of incidence rate and true risk. In response to this important issue, it must be emphasized to the reader that the approach to pharmacovigilance that we have utilized in this instance is not designed to address causality and/or risk quantification, but rather this widely accepted approach focuses on detection of a safety signal.
Pharmacovigilance using public ‘big data’ adverse event databases is now one key approach to the rapid advancement of patient safety. For example, and also reflective of our approach to pharmacovigilance, a signal for interstitial pneumonia and ustekinumab was detected and reported by the U.S. Food and Drug Administration (FDA) via FAERS (the FDA Adverse Event Reporting System), and yet this risk is also not described in the full prescribing information.3 Similarly to the FDA pharmacovigilance and reporting described above, our report describes a safety signal for cancers not previously described for ustekinumab.
