Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System.

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Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System.

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System.

アブストラクト	BACKGROUND: In this study, we fill this gap in knowledge by updating the safety profile of ubrogepant and rimegepant via disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), a US-based database registering spontaneous reports. RESEARCH DESIGN AND METHODS: ASCII files of quarterly extraction of FAERS data were downloaded from the FDA website up to the 3(rd) quarter (Q3) of 2021 (last accessed 03/02/2022). Disproportionality analysis was done using the Reporting Odds Ratio (ROR) as a disproportionality measure. RORs of all AEs related to ubrogepant and rimegepant in FAERS were calculated in comparison with those related to erenumab. Drug-event pairs with a frequency </= 2, were removed according to European Medicine Agency (EMA)'s procedures. RESULTS: In total, 2010 and 3691 individual case safety reports (ICSRs) recorded in FAERS reported ubrogepant and rimegepant, respectively, as suspect drugs. Ten disproportionality signals for ubrogepant and 25 disproportionality signals for rimegepant were identified; these were mostly related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious type of adverse events. CONCLUSIONS: New safety aspects related to the treatment of ubrogepant and rimegepant using disproportionality analysis from spontaneous reporting databases were identified. Further studies are needed to confirm these findings.
ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2023/6/9
投稿者	Battini, Vera; Carnovale, Carla; Clementi, Emilio; Sessa, Maurizio
組織名	Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen,;Denmark.;Pharmacovigilance & Clinical Research, International Centre for Pesticides and;Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC),;ASST Fatebenefratelli-Sacco University Hospital, Universita Degli Studi di;Milano, Milan, Italy.;Scientific Institute, IRCCS E. Medea, Bosisio Parini, LC, Italy.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/37293948/