Other safety alerts
|
| |
| The United Kingdom: Latanoprost (Xalatan): increased reporting of eye irritation since reformulation |
| |
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. The MHRA 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.
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.
Healthcare professionals are advised of the following 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 refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/latanoprost-xalatan-increased-reporting-of-eye-irritation-since-reformulation
In Hong Kong, Xalatan Eye Drops 50ug/ml (HK-42158) is a pharmaceutical product registered by Pfizer Corporation Hong Kong Limited (Pfizer) and has the pH specification of 6.5-6.9. According to Pfizer, the formulations of Xalatan in UK and Hong Kong are different. So far, DH has not received any ADR case related to Xalatan. The adverse effect of eye irritation has been included in the package insert of Xalatan. DH will continue to remain vigilant on future safety announcements of Xalatan by other overseas health authorities.
Ends/ Tuesday, July 21, 2015
Issued at HKT 17:00
|
| |
