Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2005 Jul;60(1):98-102.
doi: 10.1111/j.1365-2125.2005.02373.x.

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

Hilary M Pearce  1 , Deborah Layton, Lynda V Wilton, Saad A W Shakir
Affiliations

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

Hilary M Pearce et al. Br J Clin Pharmacol. 2005 Jul.

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.

PubMed Disclaimer

References

    1. Vandenbroucke JP, Rosing J, Bloemenkamp KWM, et al. Oral contraceptives and the risk of venous thrombosis. N Engl J Med. 2001;344:1527–1535. - PubMed
    1. Kemmeren JM, Algra A, Grobbee DE. Third generation oral contraceptives and risk of venous thromboembolism: meta-analysis. BMJ. 2001;323:1–9. - PMC - PubMed
    1. The European Agency for Evaluation of Medicinal Products (EMEA) EMEA Committee for Proprietary Medicinal Products (CPMP) Public Assessment ReportCombined Oral Contraceptives and Venous Thromboembolism. http://www.emea.eu.int/pdfs/human/regaffair/0220101en.pdf 28 September 2001.
    1. Rosendaal FR, Helmerhorst FM, Vandenbroucke JP. Female hormones and thrombosis. Arterioscler Thromb Vasc Biol. 2002;22:201–210. - PubMed
    1. The European Agency for Evaluation of Medicinal Products (EMEA) EMEA Committee for Proprietary Medicinal Products (CPMP) Draft note for Guidance on Clinical Investigation of Steroidal Contraceptives in Women. http://www.emea.eu.int/pdfs/human/ewp/051998en.pdf 23 June 2004.

Substances