Published: September 2012

MARC's Remarks: June 2012 Meeting

Prescriber Update 33(3): 25-26
September 2012

The Medicines Adverse Reactions Committee (MARC) met on 21 June 2012 to review a number of possible medicine related safety issues.

The MARC was provided with a review of the risk of progressive multifocal leukoencephalopathy (PML) in association with the use of monoclonal antibodies. The MARC agreed that although PML is a very rare result of treatment with some monoclonal antibodies, it has very serious consequences. Further information about PML can be found in this edition of Prescriber Update1.

The MARC reviewed the dosing and administration recommendations of haloperidol. The MARC agreed that evidence from the literature suggests that oral or intravenous doses greater than 10mg per day are unlikely to provide further benefit and may increase the risk of adverse events. The MARC recommended that initial and maximum doses for haloperidol be reviewed and changes clearly outlined in the data sheets.

The MARC was provided with a review of statins and the risk of development of new-onset type 2 diabetes mellitus (T2DM). The MARC recommended that data sheets be updated to include information on those patients more likely to be at risk of developing T2DM. Further information relating to this matter can be found in this edition of Prescriber Update2.

The MARC reviewed a recent paper and a summary of published literature on hypnotic use and mortality. Additional information about this issue can be found in this edition of Prescriber Update3.

Further information about all of these issues is available from the MARC meeting minutes published on the Medsafe website

  1. Medsafe, Therapeutic Goods Administration. 2012. PML: a rare but serious disease. Prescriber Update 33(3): 21-23.
  2. Medsafe. 2012. Statins — A risk of diabetes mellitus? Prescriber Update 33(3): 24-25.
  3. Medsafe. 2012. Hypnotics: no time to be weary. Prescriber Update 33(3): 29.