Deep vein thrombosis and pulmonary embolism reported in the Prescription Event Monitoring Study of Yasmin.
OBJECTIVE
To evaluate cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) reported in a prescription event monitoring study of Yasmin, an oral contraceptive.


METHODS
Reports of DVT/PE and events suggestive of DVT/PE were followed up by questionnaire.


RESULTS
Thirteen cases (DVT five; PE eight), each with possible risk factor(s), were identified in 15 645 females using Yasmin. Applying complete case analysis, the crude incidence rate was 13.7 cases per 10 000 woman-years (95% confidence interval 7.3, 23.4).


CONCLUSIONS
Yasmin is associated with venous thromboembolism. An incidence rate has been calculated, but this may be subject to bias and should be interpreted with caution.
Pearce
Hilary M
HM
Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, UK.
Layton
Deborah
D
Wilton
Lynda V
LV
Shakir
Saad A W
SA
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D011307:Drug Prescriptions; D005260:Female; D006801:Humans; D011655:Pulmonary Embolism / Q000139:chemically induced*; D012307:Risk Factors; D011795:Surveys and Questionnaires; D020246:Venous Thrombosis / Q000139:chemically induced*
D003277:Contraceptives, Oral, Combined