June 16, 2016 — A woman from Mississippi who did not re-grow her hair after undergoing breast cancer chemotherapy with Taxotere has filed a lawsuit against Sanofi-Aventis.
The lawsuit (PDF) was filed by Christine Tolefree in federal court in Mississippi on June 2 — Case No. 3:16-cv-00412.
She was diagnosed with breast cancer in May 2014. When discussing treatment options with her oncologist, she was never warned about the risk of permanent hair loss from Taxotere.
Like dozens of other women, Tolefree still suffers from disfiguring baldness. Most people go bald during chemotherapy, but permanent hair loss is not a normal or common side effect.
In 2009, the FDA warned Sanofi-Aventis for overstating the benefits of Taxotere and minimizing important risk information. The agency updated the label on Taxotere to include “permanent alopecia” in December 2015.
However, evidence linking Taxotere and alopecia has been growing for years. In 2005, a clinical trial found that 9.2% of women who were treated with the TAC regimen (Taxotere, Adriamycin, and Cyclophosphamide) had hair loss that persisted in the 10-year follow-up period. Other studies have estimated a 3-6% risk.
Until recently, the label on Taxotere reassured women that hair “generally grows back” after completing treatment. The label has since been revised to say, “In some cases (frequency not known) permanent hair loss has been observed.”
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