title: Reflections after the Diane affair.
abstract: 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. Pharmacovigilance not only has the aim to improve knowledge on risk of medicines, but also the aim of getting this knowledge into Health Care practice.
authors.affiliation: Netherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Kant
authors.forename: E
authors.initials: E
authors.lastname: van Puijenbroek
authors.forename: F
authors.initials: F
authors.lastname: van Hunsel
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D017373:Cyproterone Acetate / Q000009:adverse effects*; D004338:Drug Combinations; D004345:Drug Industry; D004997:Ethinyl Estradiol / Q000009:adverse effects*; D005260:Female; D005602:France; D006801:Humans; D060735:Pharmacovigilance; D013927:Thrombosis / Q000139:chemically induced* / Q000401:mortality / Q000517:prevention & control
chemical_list: D004338:Drug Combinations; D004997:Ethinyl Estradiol; D017373:Cyproterone Acetate; C032640:Cyproterone acetate, ethinyl estradiol drug combination
keywords: Diane-35; adverse drug reaction; cyproterone acetate; embolism; ethinyl estradiol drug combination; thrombosis