Latanoprost (Xalatan): increased reporting of eye irritation since reformulation

Advise patients to tell their health professional if they experience severe eye irritation.

From:
Medicines and Healthcare products Regulatory Agency
Published
20 July 2015
Therapeutic area:
Ophthalmology

When prescribing or dispensing the Xalatan brand of latanoprost:

  • advise patients to tell their health professional if they experience severe eye irritation
  • review treatment if patients mention severe eye irritation
  • please continue to report suspected side effects to latanoprost or any other medicines on a Yellow Card

Xalatan is an eye-drop formulation of latanoprost. It is licensed for the reduction of intraocular pressure in adults and children with ocular hypertension and open angle glaucoma.

In 2013, the Xalatan pH was reduced from 6.7 to 6.0 to allow for long-term storage at room temperature. Following this reformulation there has been an increase in the number of reports of eye irritation from across the EU. We received no Yellow Card reports of eye irritation in people using Xalatan in the year before the reformulation, compared with 22 reports in the year after reformulation.[footnote 1]

It is important that patients continue their treatment. Therefore advise patients to tell their health professional promptly (within a week) if they have eye irritation (eg excessive watering) severe enough to make them consider stopping treatment. Review treatment and prescribe a different formulation if necessary.

Further information

Xalatan summary of product characteristics

Article citation: Drug Safety Update Volume 8 issue 12 July 2015: 2.

  1. Yellow Card reports are reports of suspected adverse drug reactions (ADRs) submitted voluntarily by healthcare professionals and members of the public in the UK. The number of reports received should not be used to determine the incidence of an ADR. This is because neither the total number of ADRs occurring, nor the number of patients using the drug is known. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, and the extent of use of a particular drug, and may be stimulated by publicity about a drug. ↩

Updates to this page

Published 20 July 2015
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