Deep vein thrombosis and pulmonary embolism reported in the Prescription Event Monitoring Study of Yasmin®

Article date: July 2005

By: Hilary M. Pearce, Deborah Layton, Lynda V. Wilton, Saad A. W. Shakir, in Volume 60, Issue 1, pages 98-102

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.

DOI: 10.1111/j.1365-2125.2005.02373.x

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