Cox 2 inhibitors - Media advisory 15 March 2005
Cox 2 inhibitors
Media advisory 15 March 2005
As indicated at a media conference earlier this month the Medicines Adverse Reaction Committee - MARC - is meeting today to determine its final recommendations to the Minister of Health on Cox 2 inhibitors. It will be considering new data submitted by pharmaceutical companies as well as research published since we gave our inital advice.
Please be advised that neither the committee nor the Ministry will be making any statement during or immediately following the meeting, as MARC's recommendations will go through normal process as outlined in the attch diagram.
In the interim Medsafe advises that the advice given to prescribers, and outlined in media statements still stands.
Process for MARC
Data submitted to Medsafe from sponsors
(i.e. pharmaceutical companies)
Studies published in the medical literature
Local and international reports of adverse events
Reviewed by MARC
Recommendations made by the committee
Minutes of meeting are recorded
MARC members and Chair ratify minutes
Medsafe reviews recommendations and provides
Recommendations as detailed in the minutes and Medsafe’s comments are forwarded to the Minister
Minister/Minister’s delegate accepts (or otherwise) the recommendations
Medsafe implements recommendations. This may include:
- regulatory action involving the product sponsors
- dissemination of information to prescribers
- provision of advice for consumers