Published: December 2011

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MARC's Remarks: September 2011 Meeting

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Prescriber Update 32(4): 34
December 2011

The Medicines Adverse Reactions Committee (MARC) met on 8 September 2011 and made the following recommendations:

The MARC considers the risk benefit balance of varenicline (Champix) treatment remains positive following a review of studies suggesting varenicline increases the risk of patients experiencing cardiovascular events. The MARC concluded that data available to date does not demonstrate a causal association; however the medicine data sheet has now been updated to provide more information about reports of cardiovascular events in patients taking varenicline.

The MARC reviewed a recently published meta-analysis that suggested an increased risk of mortality in COPD patients using tiotropium (Spiriva). There are two formulations of Spiriva inhalers – HandiHaler and Respimat; however only the HandiHaler formulation is marketed in New Zealand. The MARC considered that the possibility of an increased mortality risk may be present for the Respimat formulation but not the HandiHaler formulation.

The MARC reviewed recently published data on the risk of bladder cancer associated with the use of pioglitazone and considered that this data does not support a causal association. However, they agreed that it was not possible to rule this association out completely so recommended that the medicine datasheet be updated to raise awareness of this potential safety issue to healthcare professionals.

The MARC reviewed the use of oral ketoconazole (Nizoral) following its suspension in France following concerns it causes hepatotoxicity. The Committee noted that anti-fungals are commonly known to be associated with hepatic injury, with ketoconazole known to exhibit a higher risk that other agents in its class. The French review did not appear to identify any new safety data, with the MARC noting that this adverse reaction is clearly described in the New Zealand datasheet.

The Committee noted that a case of tachycardia had been reported in a patient with pre-existing heart failure treated with cyclizine. Although the use of cyclizine in patients with heart failure is already cautioned, the MARC considered that this report serves as a useful reminder to healthcare professionals of this adverse effect.

Further information about all of these issues can be found in the meeting minutes, available at: www.medsafe.govt.nz/profs/adverse/Minutes147.htm