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Safety Information

Revised: 5 December 2017

Early Warning System Monitoring Communications

Medicines and medical devices have important benefits in treating and preventing disease but can also cause side effects in some people.

This section contains communications issued by Medsafe for safety concerns with medicines and medical devices shortly after they have been identified. These safety concerns have not been fully investigated. These communications highlight potential safety concerns. The publication of monitoring communications is part of Medsafe's proactive approach to monitoring the safety of medicines and medical devices.

Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (PDF 224 KB, 9 pages)

Safety concerns with monitoring communications have not been reviewed in detail. It is unknown if the safety concern(s) are linked to the medicine or medical device or are coincidental.

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.

Consumers are advised to use medicines and medical devices according to the instructions provided. For medicines, these are also outlined in the Consumer Medicine Information (CMI). For medical devices these are outlined in the instructions for use or user manual supplied with the medical device. Your healthcare professional can also provide help and assistance. Further information may be found on the product packaging or the company supplying the medicine or medical device may operate a helpline.

Healthcare professionals should not change a patient's treatment because of a monitoring communication.

It is likely that the some monitoring communication safety concerns will not result in any action being taken and the monitoring communication will be updated accordingly. If the Medsafe review of the safety concern concludes that there is a demonstrated link with a medicine or medical device an alert may be issued. Where required we will take appropriate action to improve the safe use of this medicine or medical device.

Monitoring Communications Issued in the Last Six Months

Date Medicine/Device Title
5 December 2017 Medicine Update - Possible risk of hypothyroidism in infants exposed to iodine-containing contrast agents
25 August 2017 Medicine Watch out for INR changes when direct-acting antivirals (DAAs) are used concomitantly with warfarin
12 May 2017 Medicine Direct-acting antiviral (DAA) regimens and liver failure
24 March 2017 Device Animas Vibe Insulin Pump and Blood Glucose Analyser - ongoing issues with screen fade, cracked battery casing and other issues.
13 March 2017 Medicine M² logo Viekira Pak and Viekira Pak-RBV – Possible effects on blood glucose control when used in patients with type 2 diabetes
2 March 2017 Medicine M² logo Possible risk of hypothyroidism in infants exposed to iodine-containing contrast agents added to the medicines monitoring scheme

Archived list of monitoring communications

If you are aware of someone who may have experienced one of these safety concerns please report it. This helps Medsafe to investigate these safety concerns and decide if any action needs to be taken. Safety concerns for which Medsafe is seeking further reports are also highlighted with M² logo

Find out more about medicines monitoring M² logo

Further Information

Consumer question and answers on the early warning system

Information about the early warning system

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