Deep Vein Thrombosis and Pulmonary Embolism Reported in the Prescription Event Monitoring Study of Yasmin

Br J Clin Pharmacol. 2005 Jul;60(1):98-102. doi: 10.1111/j.1365-2125.2005.02373.x.

Abstract

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.

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Contraceptives, Oral, Combined / adverse effects*
  • Drug Prescriptions
  • Female
  • Humans
  • Pulmonary Embolism / chemically induced*
  • Risk Factors
  • Surveys and Questionnaires
  • Venous Thrombosis / chemically induced*

Substances

  • Contraceptives, Oral, Combined