| アブストラクト | OBJECTIVE: Olfactory dysfunction has gained considerable interest with its association to the coronavirus pandemic. Due to the limited literature on olfactory-related adverse events (ORAE) associated with medications, this study investigated ORAE reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) to identify the most frequent medications associated with these reactions. STUDY DESIGN: Cross-sectional analysis SETTING: FAERS database. METHODS: The FAERS database was accessed to obtain ORAEs from 2012 to 2022. Disproportionality analysis was conducted by calculating the proportional reporting ratios (PRR) and reporting odds ratio (ROR) for anosmia, parosmia, hyposmia, and olfactory dysfunction. A PRR > 2 or ROR > 1 was significant. A multivariate logistical model was used to estimate adjusted ROR for gender and country of origin. RESULTS: Our final study population consisted of 1111 cases with the following symptoms: anosmia (672), parosmia (364), hyposmia (71), and olfactory dysfunction (4). The most significant ROR signal scores were found for secukinumab (3.42; 95% confidence interval, CI [1.9, 4.01]) for anosmia, levofloxacin (8.86; 95% CI [2.83, 9.8]) for hyposmia, and pregabalin (6.88; 95% CI [2.23, 8.01]) for parosmia. No significant PRR signal scores were found for anosmia, but significant signals were found for citalopram hydrobromide (17.25; 95% CI [17.01, 17.49]) in hyposmia, and dimethyl fumarate (3.18; 95% CI [3.09, 3.27]) in parosmia. No valid PRR or ROR values were found for olfactory dysfunction. Multivariate analysis did not reveal statistically significant differences between genders for any symptoms, but individuals from non-US countries did exhibit statistically significant elevated risk of anosmia (1.3 (95% CI [1.01, 1.68]). CONCLUSION: Pharmacovigilance studies provide an opportunity to evaluate the safety profile of medications regarding ORAE, particularly for those commonly prescribed for sinonasal symptoms. Findings from this study may function as a resource for prescribers and patients. |
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| ジャーナル名 | Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery |
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| Pubmed追加日 | 2023/12/29 |
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| 投稿者 | Minutello, Katrina M; Lofgren, Daniel H; Lenkeit, Christopher P; Emmer, Eriel; Santiago Rivera, Olga; Hasan, Md Sakibur; Downs, Asha |
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| 組織名 | Department of Otolaryngology-Head and Neck Surgery, Mclaren Oakland Hospital,;Pontiac, Michigan, USA.;Department of Osteopathic Surgical Specialties, Michigan State College of;Osteopathic Medicine, East Lansing, Michigan, USA.;Mclaren Oakland Hospital, Pontiac, Michigan, USA.;North Oakland Ear, Nose, & Throat Centers P.C., Clarkston, Michigan, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38156529/ |
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