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Health Canada Health products

FASLODEX (fulvestrant) - Risk of Unnecessary Therapy Modification due to Falsely Elevated Estradiol Levels

Issued October 18, 2016
Issue
Medical and scientific literature as well as post marketing reports suggest that fulvestrant can cross react with estradiol (E2) immunoassays due to structural similarity with estradiol. The false E2 positive assays may lead to misinterpretation of the menopausal status of women therefore putting patients at risk for unnecessary surgery or endocrine therapy modification.
Hazard description
Product safety