Published: 3 March 2016

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MARC’s Remarks: December 2015 Meeting

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Prescriber Update 37(1): 13
March 2016

The Medicines Adverse Reactions Committee (MARC) met on 3 December 2015 to discuss a number of medicine-related safety issues.

The MARC discussed a number of safety concerns recently associated with Gardasil (HPV) vaccination. The MARC concluded that there is no safety concern relating to the development of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) after Gardasil vaccination.

The MARC reviewed the available information on the risk of pneumonia with inhaled corticosteroids. The MARC considered that there appears to be an association between inhaled corticosteroids and pneumonia and that this was likely a class effect. The Committee noted that information on the management of patients with chronic obstructive pulmonary disease can be found in a recently published article by the Best Practice Advocacy Centre (www.bpac.org.nz/BPJ/2015/February/copd-part1.aspx).

The MARC discussed the association between the use of hormone replacement therapy by post-menopausal women and the risk of ovarian cancer. The MARC considered that the risks are well articulated in the data sheets and women should be able to make an informed choice about the use of these medicines.

The MARC reviewed the available information on a safety concern of retinopathy in preterm infants associated with the use of epoetin beta. The MARC concluded that the evidence was insufficient to support an association.

The MARC discussed the use of oral contraceptives containing drospirenone and dienogest and the risk of venous thromboembolism The MARC considered that the data sheets and consumer medicine information accurately reflect the available information. Further information relating to the use of hormonal contraceptives can be found in the Consumer Educational Material on the Medsafe website (www.medsafe.govt.nz/consumers/educational-material.asp).

Following the 163^rd meeting held on 10 September 2015, Medsafe obtained further information relating to cross-reactivity with beta-lactam antibiotics. The MARC reviewed this new information and discussed the availability of skin testing in the community. The MARC recommended that the data sheets for cephalosporin-containing products should be updated to harmonise the contraindications and warnings and precautions. An article on this topic will be published in a future edition of Prescriber Update.

Review of CARM’s Quarterly Report indicated that some of the serious and fatal adverse reactions may have resulted from medication errors. A number of different themes were identified.

• Failure to note MedicAlert or patient history about serious adverse drug reactions leading to re-administration of the same medicine (www.medsafe.govt.nz/profs/PUArticles/March2014MedicineInducedAnaphylaxis.htm).
• Use of a non-steroidal anti-inflammatory drug (NSAID) with anticoagulants leading to haemorrhage (www.medsafe.govt.nz/profs/PUArticles/June2015/June2015OralAnticoagulants.htm).
• Administration of an NSAID to a very elderly patient without gastroprotection (www.medsafe.govt.nz/profs/PUArticles/ReducingGIReactionRiskwith%20NSAIDsAndCox2.htm).
• Prescribing NSAIDs to patients already taking an ACE inhibitor and a diuretic causing acute renal failure (www.medsafe.govt.nz/profs/PUArticles/DangTrio.htm).
• Prescribing medicines excreted via the kidney to patients with severe renal failure (check data sheet contraindication www.medsafe.govt.nz/Medicines/infoSearch.asp).

Further information on this meeting can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes164.htm)