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.
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.
Authors: J P Vandenbroucke; J Rosing; K W Bloemenkamp; S Middeldorp; F M Helmerhorst; B N Bouma; F R Rosendaal Journal: N Engl J Med Date: 2001-05-17 Impact factor: 91.245
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