The study was published in the BMJ Open this month and was titled: ‘Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents‘.
Dr Victoria Cornelius (former member of the Medstats team, now at Imperial College) lead the study, along with Dr Kun Liu (Medstats member), Prof Janet Peacock (Medstats member) and Dr Odile Sauzet (associate member of the MedStats team).
This paper was dedicated to Kun Liu, our dear colleague, who sadly died in December 2015.
The comparison review study found notable variation in the product information sheets that list and describe adverse events for drugs between the UK and US versions. The authors suggest that this has implications for what is recognised as an adverse event and information which is given to patients.