Drug-induced hearing loss: a case/non-case study in the French pharmacovigilance database.

Hearing loss is defined as a decrease in the ability to perceive sounds which can occur suddenly or gradually and affects one ear or both. It is related to various etiologies, in particular drugs. The identification of all drugs that could be associated with hearing loss is essential for the patients' life quality. The objective of our study was to identify signals of hearing loss involving drugs approved in the last 20 years. The occurrence in association with drugs known for their ototoxicity was also analyzed. We used a case/non-case method in the French Pharmacovigilance Database (FPVD). The cases were reports of hearing loss in the FPVD between January 2007 and August 2017. Non-cases were all reports over the same period. We calculated the reporting odds ratio (ROR) with 95% confidence intervals. Among the 555 reports of hearing loss, significant RORs were found for 68 drugs. The main therapeutic classes implicated were antineoplastic agents (n = 240), systemic anti-infective agents (n = 182), immunosuppressants (n = 42) loop diuretics (n = 26), and salicylate analgesics (n = 26). We found signals of hearing loss with azacitidine, vaccines and nevirapine, immunosuppressants such as leflunomide, and biotherapies such as panitumumab and vandetanib. Prescribers should be informed about the potential associations with all these drugs. The role of the pathology itself and the known ototoxic drugs that can be associated do not allow to conclude definitively. Audiograms for the early detection of hearing loss induced by drugs known to be ototoxic are rarely carried out. Preventive treatments exist and must be considered.

Middle fossa approach for resection of vestibular schwannoma: impact of cochlear fossa extension and auditory monitoring on hearing preservation.

OBJECTIVE: To analyze the impact of patient selection and auditory monitoring on hearing results after middle fossa craniotomy approach for resection of a vestibular schwannoma (VS). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Patients undergoing a middle fossa craniotomy for resection of VS at a single institution between 1995 and 2006 were included in the study population. Patients presenting with Neurofibromatosis Type 2 or who underwent a combined approach (middle fossa and retrosigmoid) were excluded. MAIN OUTCOME MEASURES: Hearing preservation as measured by serial audiograms. RESULTS: Seventy-seven patients were identified. Before excluding patients with cochlear fossa enhancement and the use of auditory monitoring, 47% of the patients maintained serviceable hearing (American Academy of Otolaryngology-Head and Neck Surgery Class A or B). By selecting tumors that did not involve the cochlear fossa and using auditory monitoring, serviceable postoperative hearing was preserved in 76% of the patients. CONCLUSION: Modification of our selection criteria for surgery and the use of auditory monitoring have improved our hearing results for patients undergoing a middle fossa approach for resection of VS from 47% to 76%.

PNIF measurement in a healthy French population. A prospective study about 234 patients.

OBJECTIVE: A prospective study in a healthy French population to evaluate the normal range of PNIF. MATERIAL AND METHODS: In total, 234 subjects separated into 2 groups (group 1: patients with VAS >or= 8, n = 151 and group 2: patients with VAS < 8, n = 83) have been prospectively enrolled in this study from September 2003 to April 2004. For all participants, nasal obstruction was evaluated through a VAS and two PNIF measurements. RESULTS: The mean PNIF measurements in group 1 and group 2 were 87.5 L/min and 84.7 L/min, respectively with a significant difference between male and female in both groups (p < 0.0001). The reproducibility in group 1 and group 2 was 5.1 L/min and 4.4 L/min respectively. A slight tendency to a reduction due to the age was observed except for patients over 60. CONCLUSION: This study confirms that the technique of PNIF measurement is reliable and simple. The normal range of PNIF in a healthy French population has been determined although our results show lower values than previous published reports from other countries. However, it remains an attractive method for the follow-up and survey of patients complaining of nasal obstruction.