[Analysis of reports of otoxicity, with symptoms of tinnitus, in the database of the Spanish Pharmacovigilance System for medicinal products for human use.]

Objective: One of the adverse drug reactions (ADR) can be the Ototoxicity, either in a cochlear level or in a vestibular one. This may cause an incapacitating symptomatology due to a hearing impairment or deafness, tinnitus, or a vertiginous syndrome. The objective of this work was to analyze the notifications of ototoxic ADRs registered in the FEDRA database of the Spanish Pharmacovigilance System for Medicinal products for Human Use (SEFV-H), manifested as tinnitus, describing epidemiological and prognostic factors, as well as active principles and associated therapeutic groups.

Methods: An observational retrospective study based on the incoming registers in the FEDRA database of the SEFV-H, with tinnitus symptomatology due to ototoxicity between 1984 and 2017 has been carried out. SPSS v.20.0 program has been used for the descriptive and inferential statistics searching elements related to the emergence, seriousness or recuperation of the tinnitus.

Results: A total of 662 patients notifications were obtained with 899 suspected drugs. 64% of the patients were women. The average age was 55.8 years old. An 8.5% of the tinnitus were classified as serious, meaning a significant and persistent disability. Evaluating the causality through the modified Karch-Lasagna algorithm (SEFV-H algorithm), a causal group credible or well defined, was discovered in 48.6%. In the ATC ranking, the most frequent group of cause drugs was the N, nervous system. It was concluded, among others, that the seriousness is more significant in men and that the elder group have a great influence in the tinnitus recovery.

Conclusions: The appearance of tinnitus brought on by medical ototoxicity may determine an important limitation on the patient. A vestibular and cochlear function monitoring must be carried out on patients under treatment with high ototoxicity drugs. The task of the pharmacovigilance seems to be essential, by spreading its results and stimulating the ADR notifications in order to identify pharmacological threats.