Published: 5 March 2020

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MARC’s remarks: December 2019 meeting

Prescriber Update 41(1): 13
March 2020

The Medicines Adverse Reactions Committee (MARC) met on 5 December 2019 to discuss a number of medicine-related safety issues.

Based on a case reported to the Centre for Adverse Reactions Monitoring (CARM ID 133836), where a young patient developed hyponatraemia and tonic/clonic convulsions after using desmopressin, the MARC recommended further communication on the need for concomitant fluid reduction with desmopressin. For more information, see the Gathering Knowledge article in this edition of Prescriber Update.

The MARC discussed the benefits of use and risks of harm of the cough suppressant pholcodine. The MARC considered that the benefit-risk balance is marginal, but there is currently insufficient evidence to indicate an unfavourable benefit-risk balance. The MARC recommended the Medicines Classification Committee consider reclassifying pholcodine to a more restricted classification.

The MARC discussed the use of direct-acting oral anticoagulants and the risk of recurrent thrombotic events. The MARC determined that there is currently insufficient evidence of a rebound effect.

The MARC discussed the use of cyproterone acetate and the risk of hepatic toxicity. The MARC recommended that data sheets should be updated to clarify that hepatic toxicity is not gender specific and can happen at doses lower than the 200–300 mg currently described in the data sheets.

The potential drug-drug interaction between capecitabine and proton pump inhibitors (PPIs) was discussed. The proposed mechanism of the interaction is that PPIs increase gastric pH, which may reduce the dissolution and absorption of capecitabine. The MARC recommended data sheet updates to outline this potential interaction and recommended communication with oncologists to inform them of the MARC’s discussion on this topic.

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

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