Revised: 24 February 2016
The scheme has been incorporated into the Early Warning System Monitoring Communications.
Monitoring Communication safety concerns displaying the logo:
This helps CARM and Medsafe to investigate these safety concerns and decide if any action needs to be taken.
The appearance of a possible safety issue to a medicine does not mean that Medsafe and CARM have concluded that this medicine causes the reaction.
Medsafe emphasises that the listing of a medicine does not mean that Medsafe is suggesting that healthcare professionals do not use these medicines or that patients should stop taking any medicine highlighted here.
Medsafe and CARM are seeking further information on these safety concerns to investigate whether there is evidence that the medicine causes the reaction.
Patients with any concerns about medicines they are taking should talk to their doctor.
This scheme does not replace the Intensive Medicines Monitoring Programme (IMMP) or spontaneous reporting of suspected adverse reactions in New Zealand.
Please send your report to CARM as for any suspected adverse reaction. This can be done even if the reaction happened some time ago. Please include as much information as possible as this helps the medical assessors at CARM to investigate whether the medicine caused the reaction.
Please continue to report all suspected reactions to all medicines to CARM. This helps us to identify new potential safety issues for further monitoring in this scheme.
Once you have submitted a report to CARM you will receive a reply thanking you for your report and providing you with some general information about the medicine and the reaction.
CARM and Medsafe regularly examine the reports in the adverse reaction report database. When a safety concern is identified and further spontaneous reports will provide useful information, it is placed on the list. Safety concerns may be based on groups of reports to CARM or a single well documented case. Safety concerns remain on for 6 months, but this may vary depending on the medicine and reaction.
Once the active monitoring period for a potential safety signal has ended Medsafe and CARM evaluate the signal.