Ondansetron induced blindness: a pharmacovigilance database study

ABSTRACT

Background

Ondansetron is an antiemetic drug (AED) used to prevent and treat nausea and vomiting. The summary of product characteristics reports a rare risk of transient blindness primarily during IV injections, notably with the concomitant use of chemotherapeutic agents. We aimed to refine the characterization of ondansetron-induced blindness.

Research design and methods

We performed a descriptive and a case/non-case analysis using VigiBase®. Cases were defined as reports of adverse drug reactions (ADRs) related to blindness: amaurosis, amaurosis fugax, blindness. Non-cases were all other recorded reactions. Reporting risk of blindness-related ADRs was assessed using a disproportionality analysis and expressed as Reporting Odds Ratios (ROR).

Results

138,315 ADRs were reported with AEDs, including 136 blindness-related ADRs, among them 44 (32.4%) with ondansetron. For ondansetron users, blindness-related ADRs occurred mainly on the first day. Out of the 25 patients with known outcomes, 18 (72.0%) were recovering or had recovered, 7 (28.0%) patients had not recovered There were no statistical differences in the number of cases for IV or oral users and for users or not of chemotherapeutic agents. Compared with other AEDs, ondansetron was associated with an increase in the reporting risk of blindness-related ADRs (ROR = 4.00 [2.79–5.72], p < 0.001).

Conclusions

Rarely blindness can occur following intravenous or oral administration of ondansetron.

KEYWORDS:

• Adverse drug reaction
• pharmacovigilance
• VigiBase
• ondansetron
• blindness
• drug safety

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethical approval

Not applicable. No consent was required as we worked on individual case safety reports.

Author contribution statement

GW initiated the study. RB and GW performed data analyses. RB drafted the first version of the manuscript. RB, GW, CP and SG critically reviewed the manuscript and revised it. All authors contributed substantially to the study’s concept and design, interpreted the data, and reviewed the manuscript.

Acknowledgments

This work was presented as an abstract during the congress of the French Society of Pharmacology and Therapeutics held in 2022 in Lille.

Additional information

Funding

This paper was not funded.