Medicines Monitoring
Justification for medicine reaction combination
being included on 
.
| Medicine |
Pantoprazole / Lansoprazole |
| Reaction identified |
Hypomagnesaemia |
| Number of cases (number in last 12 months) |
1 (Pantoprazole) |
| PRR/ IC/EBGM* |
7.6 (Medsafe PRR estimate) |
| Is this reaction or a similar reaction
listed for this medicine in other jurisdictions or for other medicines
in the class? |
Listed for omeprazole; is this a class
effect?
|
| Is this medicine funded? Or state usage data |
Lansoprazole ~ 15,000
patients per year, Pantoprazole ~ 38,000 patients per year. Both are
funded. |
| Note any other important information |
Probably a long term use effect |
| Discussed by MARC? State which MARC meeting
included in Quarterly Report |
No |
| Date identified |
April 2011 |
| Date for removal |
31 March 2012 |
| Medicine |
rivaroxaban |
| Reaction identified |
Atrial fibrilation |
| Number of cases (number in last 12 months) |
3 (3) |
| 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 |
| Note any other important information |
None |
| State which MARC meeting included in Quarterly Report |
N/A |
| Date identified |
Jan 2011 |
| Date for removal |
September 2011 |
| Medicine |
quetiapine |
| Reaction identified |
cardiomyopathy |
| Number of cases (number in last 12 months) |
3 (1) |
| PRR/ IC/EBGM* |
23.3 (Medsafe estimate) |
| Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for
other medicines in the class? |
Not listed for quetiapine; listed reaction for clozapine.
|
| Is this medicine funded? Or state usage data |
Yes - special authority |
| Note any other important information |
Possible confounding by previous clozapine use. |
| State which MARC meeting included in Quarterly Report |
N/A |
| Date identified |
Jan 2011 |
| Date for removal |
September 2011 |
| Medicine |
simvastatin |
| Reaction identified |
Joint pain and swelling |
| Number of cases (number in last 12 months) |
78 (11 in 2009, 3 in 2010) |
| 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? |
Mentioned as part of a hypersensitivity syndrome, but should be investigated to see if the
reaction occurs outside of the HSR. |
| Is this medicine funded? Or state usage data |
funded |
| Note any other important information |
None |
| State which MARC meeting included in Quarterly Report |
N/A |
| Date identified |
Jan 2011 |
| Date for removal |
September 2011 |
* PRR/ IC/EBGM are mathematical tools for identifying signals of disproportional reporting of suspected adverse
reactions in association with particular medicines.
