OBJECTIVES:

Signal detection is one of the most advanced and emerging field in pharmacovigilance. It facilitates early detection of adverse drug reaction. Ondansetron is a 5-HT3 receptor antagonist approved by the US Food and Drug Administration (FDA) in 1997, indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy and radiotherapy. Also approved for the treatment of postoperative nausea and/or vomiting. This study aims in the identification of Otitis media associated with Ondansetron using Disproportionality analysis of the FDA database of Adverse Event Reporting System (FAERS).

METHODS:

Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between Ondansetron use and Otitis media. The data mining algorithm used for the analysis were Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 were considered as positive signal.

RESULTS:

A total of 1426 reports for Otitis media have been reported in the FDA database. Among them 137 reports were associated with Ondansetron. Otitis media was ranked 158th among 1095 Ondansetron associated Adverse Events (AEs). Among which 47% were males and 52% were females. A positive signal was obtained with ROR: 172.545 and PRR: 168.874. Serious reports included hospitalization (70), life-threatening (16), and other serious events (2) and no death was reported. The Log Likelihood ratio for Otitis media with Ondansetron was found to be 213 and the reporting ratio was 152.746.

CONCLUSIONS:

A positive signal was observed for Ondansetron associated Otitis media, although a causal relation cannot be definitively established. Further monitoring of this AE associated with Ondansetron is necessary in future as the number of cases of Otitis media are increasing. Health care professionals should be cautious about the possibility of encountering serious AEs associated with Ondansetron.