0557 Possible Contributory and Protective Factors in Medication Associated Obstructive Sleep Apnea (OSA): Results from the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS)

Abstract

Abstract Introduction There are conflicting opinions regarding the role of medications in OSA. A Vigibase (WHO pharmacovigilance database) study (Linselle M, 2017) has suggested several drug groups in OSA pathogenesis. Sodium oxybate, benzodiazepines and opioids are most consistently associated with OSA. We examined the adverse drug reaction (ADR) of OSA with the ‘primary suspect’ drugs for the ADR, in the US Food and Drug Administration Adverse Events Reporting System (FAERS) database. Methods The FAERS database from January 1, 2004-March 31, 2019 (total ISR =12,330,939) was examined for Individual Safety Reports (ISR) with OSA as ADR and associated ‘primary suspect (PS)’ medications. Reporting odds ratios (ROR) were calculated to assess disproportionality signals with the ‘PS’ drug and OSA versus the ‘PS’ drug associated with all other ADRs in the database. Results 15,316 ISR were associated with OSA [mean±SD age: 49.21 ± 21.76 years (based on 10,311 ISR); 53.78% female (based on 12,274 ISR]. Increased disproportionality signals for OSA were detected with some of the following ‘PS’ drugs/drug groups: sodium oxybate [ROR=31.75, (95% CI 30.36-33.20)]; rofecoxib [ROR=7.85 (95% CI 7.40-8.32)], alendronate [ROR=3.60 (95% CI 3.37-3.84)], zoledronic acid [ROR=24.70 (95% CI 21.88-27.89)], omalizumab [ROR=2.36 (95% CI 2.09-2.68)], quetiapine [ROR=3.78 (95% CI 3.32-4.30), finasteride [ROR=6.03 (95% CI 5.17-7.04), pregabalin [ROR=1.19 (95% CI 1.01-1.41), isotretinoin [ROR=1.49 (95% CI 1.23-1.80)], ondansetron [ROR=3.35 (95% CI 2.77-4.06), olanzapine [ROR=2.64 (95% CI 2.17-3.20), sitagliptin [ROR=3.46 (95% CI 2.82-4.24, digoxin [ROR=2.83 (95% CI 2.24-3.57), benzodiazepines [ROR=1.80 (95% CI 1.33-2.42), and opioids [ROR=1.34 (95% CI 1.09-1.67)]. A decreased disproportionality signal was detected with several biologics including: adalimumab [ROR=0.87 (95% CI 0.79-0.95)], etanercept [ROR=0.55 (95% CI 0.49-0.61)], and infliximab [ROR=0.51 (9% CI 0.40-0.65)]. Conclusion The FAERS data supports many of the earlier findings suggesting the heterogeneity of medications associated with OSA. Biologics (mainly TNF-alpha antagonists) were associated with the previously unreported finding of a decreased OSA risk. Support None.