Medicines Monitoring
|
Medicine |
Potential safety issue |
Active monitoring period ends* |
|---|---|---|
|
Sildenafil |
Thromboembolism |
30 September 2012 |
|
Cetirizine |
Severe Mood Disorder |
30 September 2012 |
* 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 new medicines monitoring scheme, the aim of which is 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 further 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 http://www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Safety-and-Quality-of-Medicines.asp
Click on the link to download a coy of a powerpoint slide that can be used for presentations or Grand Rounds: http://www.medsafe.govt.nz/profs/M2MedicinesMonitoringslide.pptx (Microsoft Powerpoint document 62kb)
Justification for including medicine reaction combination on .
| Medicine | Sildenafil |
|---|---|
| Reaction identified | Thromboembolism (particularly pulmonary embolism) |
| Number of cases (number in last 12 months) | 0 |
| PRR/ IC/EBGM* | Not known |
| Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? | Not listed |
| Is this medicine funded? Or state usage data | Yes - special authority for Pulmonary Arterial Hypertension |
| Note any other important information | Signal identified by Netherlands Pharmacovigilance Centre (Lareb). |
| Discussed by MARC? State which MARC meeting included in Quarterly Report | No |
| Date identified | September 2010 |
| Date for removal | 30 September 2012 |
| Medicine | Cetirizine |
|---|---|
| Reaction identified | Severe Mood Disorder |
| Number of cases (number in last 12 months) |
1 case of aggressive reaction with agitation 1 case of depersonalization 1 case of depression 1 case of mood swings with suicidal tendency |
| PRR/ IC/EBGM* | N/A |
| Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? |
Anxiety is listed in one data sheet.
Aggressive reaction is listed in a different data sheet. |
| Is this medicine funded? Or state usage data | Pharmacy only |
| Note any other important information | None |
| Discussed by MARC? State which MARC meeting included in Quarterly Report | No |
| Date identified | September 2011 |
| Date for removal | 30 September 2012 |
* PRR/ IC/EBGM are mathematical tools for identifying signals of disproportional reporting of suspected adverse
reactions in association with particular medicines.