Drugs associated the most with male-factor infertility: assessment of the 2010–2020 food and drug administration (FDA) pharmacovigilance database

Abstract: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.

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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)

SLEEP ◽

10.1093/sleep/zsaa056.554 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A213-A214

Author(s):

M A Gupta ◽

B Vujcic

Keyword(s):

Adverse Events ◽

Drug Administration ◽

Reporting System ◽

Food And Drug Administration ◽

Sodium Oxybate ◽

Tnf Alpha ◽

Obstructive Sleep ◽

The Us ◽

Pharmacovigilance Database

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.

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