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Ondansetron induced blindness: a pharmacovigilance database study

R Barus1, C Potey2, S Gautier2

  • 1Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital, Toulouse, France.

Expert Opinion on Drug Safety
|October 18, 2023
PubMed
Abstract

Insights

Ondansetron, an antiemetic drug, is rarely associated with blindness. This study found ondansetron increased the risk of blindness-related adverse drug reactions compared to other antiemetic drugs.

Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Ophthalmology

Background:

  • Ondansetron is an antiemetic drug (AED) used to manage nausea and vomiting.
  • A rare risk of transient blindness, particularly with IV administration and chemotherapy, is noted in product information.
  • The study aimed to better characterize blindness associated with ondansetron use.

Purpose of the Study:

  • To analyze the incidence and characteristics of blindness-related adverse drug reactions (ADRs) linked to ondansetron.
  • To compare the reporting risk of blindness-related ADRs for ondansetron versus other AEDs.

Main Methods:

  • A descriptive and case/non-case analysis was conducted using VigiBase® data.
  • Blindness-related ADRs (amaurosis, amaurosis fugax, blindness) were identified as cases.
  • Disproportionality analysis, using Reporting Odds Ratios (ROR), assessed the reporting risk.

Main Results:

  • Out of 136,315 reported ADRs with AEDs, 136 were blindness-related, with 44 (32.4%) involving ondansetron.
  • Most ondansetron-related blindness ADRs occurred on the first day of use; 72% of patients recovered.
  • Ondansetron showed a significantly increased reporting risk for blindness-related ADRs (ROR = 4.00, p < 0.001) compared to other AEDs.

Conclusions:

  • Blindness is a rare adverse drug reaction associated with both intravenous and oral ondansetron.
  • Ondansetron use is linked to a higher reporting risk of blindness compared to other antiemetic drugs.
Keywords:
Adverse drug reactionVigiBaseblindnessdrug safetyondansetronpharmacovigilance

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