Premium
Reflections after the D iane affair
Author(s) -
Kant A.,
Puijenbroek E.,
Hunsel F.
Publication year - 2014
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.12622
Subject(s) - pharmacovigilance , medicine , adverse effect , drug reaction , intensive care medicine , adverse drug reaction , reflection (computer programming) , pharmacology , drug , computer science , programming language
Summary The Pharmacovigilance Centre Lareb received 621 reports of possible adverse drugs reactions on Diane‐35 ® . Of all reports, 388 were received after media attention. Of the 309 reports of thromboembolic adverse drugs reactions, 18 cases were fatal. In 31 cases the thromboembolic adverse drugs reaction was initially not recognized as such. The analysis and the turmoil of the ‘Diane affair’ gave rise to the following reflections: Reflection 1. Continuous awareness and attention of risk of medicines is needed, also for known risks, for timely recognition of adverse drugs reactions. Reflection 2. Reporting side effects should be part of the professional attitude. Reports play a pivotal role in the detection of new adverse drugs reactions and the conditions under which known adverse drugs reactions occur. Reflection 3. Improvement of adequate use of drugs. Farmacovigilance not only has the aim to improve knowledge on risk of medicines, but also the aim of getting this knowledge into Health Care practice.