Aims To evaluate a possible positive association between tamoxifen tre
atment and the risk of developing idiopathic venous thromboembolism (V
TE) in women with breast cancer in the absence of clinical risk factor
s for venous thromboembolism other than breast cancer itself. Methods
Using information from the large UK-based General Practice Research Da
tabase, we identified, within a cohort of more than 10 000 women with
breast cancer, all women who developed a first-time diagnosis of deep
vein thrombosis or pulmonary embolism of uncertain cause between Janua
ry 1, 1991 and December 31, 1996. In a case-control analysis, we compa
red their tamoxifen exposure experience prior to the thromboembolic ev
ent with that of a randomly selected group of control women with breas
t cancer who were matched to cases on age, year of the breast cancer d
iagnosis and calendar time. Results We identified 25 cases of idiopath
ic VTE and 172 controls, all of whom had boast cancer, but were otherw
ise free from other risk factors for VTE. Past tamoxifen exposure was
not materially associated with an elevated risk of developing VTE, and
we therefore combined never and past users as reference group. The re
lative risk estimate of VTE for current tamoxifen exposure, as compare
d with never and past use combined, was 7.1 (95% CI 1.5-33), adjusted
for body mass index, smoking status and hysterectomy status. High body
mass index was an independent predictor of VTE itself. Conclusions Ou
r study provides evidence that current use of tamoxifen increases the
risk of idiopathic venous thromboembolism.