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Safety Information

Revised: 9 September 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Ornidazole and adverse effects on the eye

1 November 2013

Since 1987 the Centre for Adverse Reactions Monitoring (CARM) have received 10 reports where the patient experienced eye problems. These eye problems were mainly described as visual impairment and blurred vision.

Products Affected

Ornidazole is used to treat bacterial infections

Additional Information

Visual impairment and/or blurred vision can affect the user’s ability to drive or operate machinery.  Anyone experiencing these problems should not drive or operate machinery.

Advice on how to take this medicine and other possible side effects can be found in the consumer medicine information (CMI) and data sheet

Consumer medicine information for ornidazole

Data sheet for ornidazole

Regulator Actions

Medsafe is placing this safety concern on the Medicines Monitoring (M² logo) Scheme to obtain further information. Please report any eye-related adverse events.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

How to report an adverse reaction

Update Information

9 September 2014

This safety concern has been investigated through M² logo . One report of visual disturbance associated with ornidazole was received by CARM around the start of the monitoring period. In this case other medicines were also suspected of causing the events. No case reports were identified in the scientific literature. It was concluded that no link between ornidazole and visual disturbances was demonstrated. Medsafe will re-investigate this concern should more information become available.

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