Published: 1 December 2022

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MARC’s remarks: September 2022 meeting

Prescriber Update 43(4): 56
December 2022

The Medicines Adverse Reactions Committee (MARC) convened on 8 September 2022.

The Committee reviewed the risk of major adverse cardiovascular events (MACE), malignancies and thromboembolism as separate events with Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib and ruxolitinib). The Committee considered that the risk of each event would be influenced by underlying risk factors in an individual and this should be considered when considering the benefit–risk for use in the individual. The Committee noted that there was currently insufficient data to distinguish whether the safety concerns differ between the medicines of the class. Therefore, the safety concerns should be treated as a class effect until further evidence is available. The Committee recommended strengthening the warning statements for MACE, malignancies and thromboembolic events in the tofacitinib and upadacitinib data sheets. The same warning statements should also be added to the ruxolitinib data sheet.

A potential drug-drug interaction between cannabidiol and systemic mammalian target of rapamycin (mTOR) (tacrolimus, cyclosporin) and calcineurin inhibitors (sirolimus, everolimus) was discussed. The Committee noted that cannabidiol likely has a wide effect on cytochrome P450 enzymes and transporters, however, this is not yet fully understood. The Committee agreed that the evidence showed a clinically significant drug interaction between cannabidiol and mTOR and recommended updates to sirolimus data sheet.

The Committee discussed quetiapine and the risk of gestational diabetes (GDM). The Committee considered that due to metabolic adverse effects, quetiapine can increase the risk of GDM. Data sheet updates were recommended.

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

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