Public recall detail

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

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Recall Safety notice
Quick summary

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

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

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

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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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.

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