Published: 7 June 2019

Publications

MARC’s remarks: March 2019 meeting

Prescriber Update 40(2): 39-40
June 2019

The Medicines Adverse Reactions Committee (MARC) met on 14 March 2019 to discuss a number of medicine-related safety issues.

The Committee discussed fingolimod and tumefactive lesions. The Committee stated that it is difficult to determine whether tumefactive lesions occur due to multiple sclerosis or fingolimod. The Committee considered that there was no strong evidence of an association with fingolimod. However, the Committee determined that due to the severity of tumefactive lesions, a warning should be included in the data sheet. Medsafe is currently working with the sponsor to update the data sheet.

The Committee discussed recent publications describing the cardiovascular risks associated with NSAIDs. For further information, please see the NSAIDs article in this edition of Prescriber Update.

The Committee discussed the use of methadone during breastfeeding. The Committee concluded that the benefit of breastfeeding while taking methadone for opioid substitution therapy outweighs the risks of harm from the transfer of methadone to the infant via breast milk. Increased monitoring during the first three weeks of life is important to ensure infant safety, and Medsafe is working with the sponsors of methadone products to include this information in the data sheets.

The Committee reviewed newly published literature on the use of nitrofurantoin in renal impairment. The Committee concluded that the overall evidence was insufficient to warrant any changes to the data sheets. Use of nitrofurantoin remains contraindicated in patients with a creatinine clearance below 60 mL/min.

The Committee discussed ergotamine-containing medicines and pancreatitis. The Committee considered that the single case received by CARM describing Cafergot and pancreatitis (CARM ID 129940) did not provide sufficient evidence of an association. However, the Committee noted that there is limited evidence of benefit and that these medicines have been removed from multiple overseas markets. The Committee recommended that Medsafe undertakes a risk-benefit review of Cafergot under section 36 of the Medicines Act 1981.

See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.

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