Safety Information

Revised: 11 February 2016

M² logo Medicines Monitoring Archive

Justification for medicine reaction combination being included on M² logo.

Medicine Melatonin
Reaction identified Hallucinations
Number of cases Three cases have been reported to the Centre for Adverse Reactions Monitoring (CARM)
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? Hallucinations are not listed in data sheets.
Is this medicine funded? Or state usage data No
Note any other important information N/A
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified June 2015
Date for removal 31 January 2016

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Medicine Guaifenesin
Reaction identified Tinnitus
Number of cases (number in last 12 months) Two reports to the Centre for Adverse Reactions Monitoring (CARM). One report described reactions of tinnitus, deafness and facial and outer ear numbness. The other report described hearing loss.
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 in data sheets or product packaging
Is this medicine funded? Or state usage data No
Note any other important information N/A
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Reported to CARM in May 2014
Date for removal 31 Oct 2015

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Medicine Zoledronic Acid
Reaction identified Tendon injury/tendinitis
Number of cases (number in last 12 months) 3
PRR/ IC/EBGM* Detected from New Zealand reports
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? There is no specific mention of tendon injury/tendinitis in the data sheets although muscle pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis and muscular weakness are listed in some of the data sheets.
Is this medicine funded? Or state usage data Yes it is funded
Note any other important information N/A
Discussed by MARC? State which MARC meeting included in Quarterly Report No
Date identified 15 April 2014
Date for removal 30 April 2015

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Medicine Bisphosphonates (alendronic acid, etidronic acid, pamidronic acid, risedronic acid, zoledronic acid)
Reaction identified Optic neuritis
Number of cases (number in last 12 months) 11 reports to the Uppsala Monitoring Centre (UMC) of optic neuritis in association with pamidronic acid, one of which originated from New Zealand.
PRR/ IC/EBGM* WHO IC = 1.32
WHO IC025 = 0.35
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? This reaction is not listed in any of the bisphosphonate New Zealand data sheets, or in other jurisdictions. Other ocular reactions that are listed in some data sheets include conjunctivitis, uveitis, scleritis, episcleritis, xanthopsia and orbital inflammation.
Is this medicine funded? Or state usage data Yes
Note any other important information Approximately 180,000 funded prescriptions for bisphosphonates were dispensed in 2013.
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Medsafe identified this April 2014.
Date for removal 31 December 2014

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Medicine Allopurinol
Reaction identified Lichenoid-type skin reactions (including lichenoid keratosis, lichen planus)
Number of cases (number in last 12 months) CARM has received four reports, three were recorded as dermatitis lichenoid and one of lichen planus-like dermatitis. One report was received in the last 12 months.
PRR/ IC/EBGM* PRR 10.5 (from May 2013)
WHO IC025 = 2.49
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? This particular type of skin reaction is not listed in the allopurinol data sheets in New Zealand. Allopurinol is well known to cause other serious skin reactions.
Is this medicine funded? Or state usage data Yes
Note any other important information Allopurinol treatment must be withdrawn at the first signs of a skin rash.
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Medsafe identified this as a safety concern for M² logo in March 2014.
Date for removal 31 October 2014

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Medicine Doxazosin
Reaction identified Nightmare (paroniria)
Number of cases (number in last 12 months) One case in the last year, seven cases in the CARM database overall
PRR/ IC/EBGM* PRR 5.4 (from May 2013)
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? This reaction is not listed in the New Zealand data sheets for doxazosin, prazosin or terazosin, or in other jurisdictions. The only listed adverse reactions that may be related are vertigo, headache, dizziness and somnolence.
Is this medicine funded? Or state usage data Yes
Note any other important information N/A
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Medsafe identified this June 2013
Date for removal 31 October 2014

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Medicine Amitriptyline
Reaction identified Peripheral coldness/Raynaud’s phenomenon
Number of cases (number in last 12 months) Eleven reports to Lareb with tricyclic antidepressants, with seven associated with amitriptyline. In New Zealand, there has been one report of localised numbness and one report of aggravated Raynaud's.
PRR/ IC/EBGM* Signal obtained from Lareb (Dutch Pharmacovigilance Centre)
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? Not specifically mentioned. Numbness, tingling, and paraesthesias of the extremities already listed in data sheets for tricyclic antidepressants
Is this medicine funded? Or state usage data Yes
Note any other important information N/A
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Medsafe identified this March 2013
Date for removal 31 July 2014

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Medicine Ornidazole
Reaction identified Adverse effects on the eye
Number of cases (number in last 12 months) 4 cases of visual impairment; 3 cases of vision blurred; 1 case of diplopia; 1 case of periorbital oedema; 1 case of mydriasis
PRR/ IC/EBGM* Vision abnormal: 5.2
Vision blurred: 5.8
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? Not specifically mentioned, is a side effect of metronidazole
Is this medicine funded? Or state usage data Yes
Note any other important information Reactions of this type are important in those patients needing to drive/work
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed
Date identified Medsafe identified this in June 2013
Date for removal 30 June 2014

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Medicine Statins (atorvastatin, simvastatin, pravastatin, rosuvastatin)
Reaction identified Acute kidney injury without rhabdomyolysis
Number of cases (number in last 12 months) Total of 38 reports relating to abnormal renal function or renal failure, with 24 reports also listing rhabdomyolysis or CK elevations
PRR/ IC/EBGM* Signal obtained from observational studies
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? Listed in the warnings and precautions section of the data sheets in the context of muscle injury (skeletal muscle)
Is this medicine funded? Or state usage data Atorvastatin, simvastatin and pravastatin are funded
Note any other important information Over 3 million prescriptions for statins were dispensed in 2012, therefore a highly utilised medicine
Discussed by MARC? State which MARC meeting included in Quarterly Report Yes, discussed at the September 2013 meeting. The MARC suggested inclusion in the M² logo programme
Date identified Medsafe identified this in April 2013
Date for removal 30 June 2014

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Medicine Varenicline
Reaction identified Interaction with alcohol
Number of cases (number in last 12 months) CARM has received five reports involving patients taking varenicline who also consumed alcohol.
CARM classified one of these reports as being an interaction.
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? Another smoking cessation medicine contains a warning/precaution regarding alcohol and advises the consumption of alcohol should be avoided.
Is this medicine funded? Or state usage data Yes
Note any other important information Medsafe's reviews of the company's latest Periodic Safety Update Report for varenicline and the CARM reports indicate this may be an emerging signal.
Discussed by MARC? State which MARC meeting included in Quarterly Report No
Date identified Medsafe identified this in January 2013
Date for removal 31 December 2013

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Medicine Ondansetron
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
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? 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

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Medicine Ibuprofen
Reaction identified Hypokalaemia and/or renal tubular acidosis
Number of cases (number in last 12 months) No previous reports to CARM in which ibuprofen was considered a suspect medicine.
There have been at least 10 literature reports primarily in patients who have taken excessive doses of combination ibuprofen 200mg/codeine 12.5mg products. At least two reports involved ibuprofen alone and one report involved therapeutic doses of ibuprofen.
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? No
Is this medicine funded? Or state usage data Yes. It is also available as a general sales medicine.
Note any other important information Severe hypokalaemia is potentially life-threatening.
Further information is required to determine if this ADR occurs with therapeutic doses of ibuprofen.
Discussed by MARC? State which MARC meeting included in Quarterly Report Not previously reviewed by the MARC
Date identified June 2012
Date for removal 31 March 2013

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Medicine SSRIs/SNRIs/Triptans
Reaction identified Thunderclap headache/Reversible Cerebral Vasoconstriction Syndrome (RCVS)
Number of cases (number in last 12 months) CARM has received 1 report of recurrent thunderclap headache due to RCVS associated with fluoxetine
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? Headache is listed in all SSRI and triptan data sheets but thunderclap headache is not listed. RCVS is listed in the sertraline data sheet but the symptoms of RCVS (ie.e recurrent thunderclap headaches) are not listed
Is this medicine funded? Or state usage data Yes. SSRIs/SNRIs and triptans are funded by PHARMAC
Note any other important information Recurrent thunderclap headaches are pathognomonic of RCVS
Discussed by MARC? State which MARC meeting included in Quarterly Report 8 March 2012
Date identified February 2011
Date for removal 31 December 2012

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Medicine Lithium
Reaction identified Diabetes mellitus type 2
Number of cases (number in last 12 months) The CARM database currently holds two cases of diabetes mellitus where lithium was suspect and one case where lithium was co-suspect
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? Hyperglycaemia is listed
Is this medicine funded? Or state usage data Prescription only
Note any other important information In all cases lithium was taken with an atypical antipsychotic. The event may therefore have been due to the atypical antipsychotic; however, there may also be an interaction occurring
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed by MARC
Date identified April 2012
Date for removal 31 December 2012

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Medicine Lansoprazole/Pantoprazole/Omeprazole
Reaction identified Hypocalcaemia
Number of cases (number in last 12 months) The CARM database currently holds one case associated with pantoprazole and five cases associated with omeprazole
PRR/ IC/EBGM* PRR 4.2 for omeprazole
Is this reaction or a similar reaction listed for this medicine in other jurisdictions or for other medicines in the class? Not listed in the data sheet
Is this medicine funded? Or state usage data Prescription only and pharmacy only
Note any other important information In all cases hypocalcaemia occurred in conjunction with hypomagnesaemia
Discussed by MARC? State which MARC meeting included in Quarterly Report Not discussed by MARC
Date identified April 2012
Date for removal 31 December 2012

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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

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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

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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

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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

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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

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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.