Revised: April 2013
|Medicine||Potential safety issue||Active monitoring period ends*|
|Ondansetron||Serotonin Syndrome (Toxicity)||30 June 2013|
* Although active monitoring will cease at this date please continue to submit reports for these medicines after this date as with all medicines.
What is ?
This is a medicines monitoring scheme, the aims of which are to:
- Highlight potential safety issues identified from reports of suspected adverse medicine reactions sent to the Centre for Adverse Reactions Monitoring (CARM).
- Stimulate further reports and increase the information on these potential safety signals.
This helps CARM and Medsafe to investigate possible safety signals 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 and possible safety signal on 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 possible safety issues to investigate whether there is in fact a causal relationship.
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 continue to report all suspected adverse reactions to CARM.
How do I submit a report for a possible safety issue listed on ?
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.
What happens next?
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.
How does operate?
CARM and Medsafe regularly examine the reports in the adverse reaction report database. When a potential safety signal is identified and it is considered that further spontaneous reports will provide useful information to investigate the signal further, it is placed on the list. Potential safety signals may be based on groups of reports to CARM or a single well documented case. Potential signals will remain on for 6 months, but this may vary depending on the medicine and reaction.
A summary of the reasons for placing a potential safety signal on is published.
Once the active monitoring period for a potential safety signal has ended Medsafe and CARM evaluate the signal. A summary of the evaluations is published.
There are a number of possible outcomes from the evaluation:
- There may not be enough evidence to determine whether there is a safety signal and no action will be taken.
- There may be enough evidence to discount the safety signal.
- There may be enough evidence to warrant further action.
Further action could include requesting and reviewing further data from the company. The company may be requested to update information in the data sheet for their medicine.
For more information on how Medsafe investigates potential safety issues and actions that may be taken see www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Safety-and-Quality-of-Medicines.asp
Click on the link to download a copy of a powerpoint slide that can be used for presentations or Grand Rounds: www.medsafe.govt.nz/profs/M2MedicinesMonitoringslide.pptx (Microsoft Powerpoint document 184kb)
Justification for including medicine reaction combination on .
|Reaction identified||Serotonin Syndrome, particularly in combination with a known serotonergic medicine|
|Number of cases (number in last 12 months)||CARM has received:
two cases of serotonin syndrome in association with ondansetron taken with other serotonergic medicines
|Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class?||Headaches, seizures, movement disorders (including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia) and dizziness (during IV administration) are listed in the data sheets; some of these adverse reactions overlap with symptoms of serotonin toxicity|
|Is this medicine funded? Or state usage data||Prescription Only|
|Note any other important information||N/A|
|Discussed by MARC? State which MARC meeting included in Quarterly Report||Discussed by MARC, September 2012 and recommended for inclusion|
|Date identified||June 2012|
|Date for removal||30 June 2013|
* PRR/ IC/EBGM are mathematical tools for identifying signals of disproportional reporting of suspected adverse reactions in association with particular medicines.