Revised: 9 June 2016
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.
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.
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.
|30 May 2016||Medicine||Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme|
|26 May 2016||Medical Device||Apex e-chamber spacer device - user issues with valve and round mouthpiece|
|26 May 2016||Medical Device||EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results|
|1 March 2016||Medicine||Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme|
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