Little Consistency Among Leading Nations Regarding Drug Safety Warnings Interview with:

Dr Barbara Mintzes PhDAssociate Professor The University of Sydney Charles Perkins Centre and School of PharmacyFaculty of Medicine and HealthThe University of Sydney

Dr. Mintzes

Dr Barbara Mintzes PhD
Associate Professor
The University of Sydney Charles Perkins Centre and School of Pharmacy
Faculty of Medicine and Health
The University of Sydney What is the background for this study?  

Response: When medicines are approved for marketing, the information available on rare serious harmful effects, longer-term effects, and outcomes in vulnerable populations is often limited. New serious safety concerns often arise when a medicine is already on the market. In many cases these can be  managed for example through dose reductions or avoiding prescribing to at-risk patients. Drug regulatory agencies such as the US FDA often issue safety warnings to let health professionals and the public know  about new evidence of potential harm and often to provide advice on how to avoid this.

We were interested to know how consistent these warnings are between different countries. This is a research project funded by Australia’s National Health and Medical Research Council and the Canadian Institutes of Health Research. We examined warnings for medicines in Australia, Canada the US and the UK over a 10-year period, from 2007 to 2016 inclusive. We were looking at how often regulators issue the same warning if the drug is approved for marketing at the time.  Continue reading