Official warnings on thromboembolism risk with oral contraceptives fail to inform users adequately.
Following the 1995 "pill scare" relating to the risk of venous thrombosis from taking second- or third-generation oral contraceptives, the Committee on Safety of Medicines (CSM) withdrew their earlier recommended restrictions on the use of third-generation pills and published recommended wording to be used in patient information leaflets. However, the effectiveness of this wording has not been tested. An empirical study (with 186 pill users, past users, and non-users) was conducted to assess understanding, based on this wording, of the absolute and relative risk of thrombosis in pill users and in pregnancy. The results showed that less than 12% of women in the (higher education) group fully understood the absolute levels of risk from taking the pill and from being pregnant. Relative risk was also poorly understood, with less than 40% of participants showing full understanding, and 20% showing no understanding. We recommend that the CSM revisit the wording currently provided to millions of women in the UK.
Berry
Dianne C
DC
Department of Psychology, University of Reading, Reading, UK. D.C.Berry@Reading.ac.uk
Raynor
D K
DK
Knapp
Peter
P
Bersellini
Elisabetta
E
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D004345:Drug Industry; D004739:England; D005260:Female; D006801:Humans; D008875:Middle Aged; D010353:Patient Education as Topic; D012308:Risk Management; D020246:Venous Thrombosis / Q000139:chemically induced*
D003277:Contraceptives, Oral, Combined