Deep vein thrombosis and pulmonary embolism reported in the Prescription Event Monitoring study of YasminŽ.
Pearce HM1, Layton D1,2, Wilton LV1,2and Shakir SAW1,2
1Drug Safety Research Unit, Southampton, UK
2University of Portsmouth, Portsmouth, UK
Summary
Aim: To evaluate cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) reported in a prescription event monitoring study of YasminŽ, 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 YasminŽ. Applying complete case analysis, the crude incidence rate was 13.7 cases per 10 000 women-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.
KEY WORDS - Oral contraceptives postmarketing, product surveillance, venous thrombosis.
