title: [Venous thromboembolism and combined oral contraceptives. Reported adverse reactions indicate at least similar risk with the most recent contraceptive pills].
abstract: Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such as venous thromboembolism (VTE), are seldom disclosed until a COC has been on the market for some time. Two new COCs, Yasmin and Cilest have recently been launched in several European countries with expectations of being safer than older COCs. Utilising data from spontaneous reporting of ADRs to the Medical Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest was estimated and compared with VTE incidence for a second (Follimin) and a third generation (Desolett) COC. The reported VTE incidence for Yasmin and Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000 users per year, respectively. The differences were, however, not statistically significant. We conclude that the risk of VTE associated with the most recent COCs is at least similar to that of older COCs.
authors.affiliation: Läkemedelsverket, Uppsala. Helle.Kieler@mpa.se
authors.forename: Helle
authors.initials: H
authors.lastname: Kieler
authors.forename: Ingemar
authors.initials: I
authors.lastname: Persson
authors.forename: Viveca
authors.initials: V
authors.lastname: Odlind
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D005260:Female; D006801:Humans; D012307:Risk Factors; D012449:Safety; D020246:Venous Thrombosis / Q000139:chemically induced*
chemical_list: D003277:Contraceptives, Oral, Combined