Aim: 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.