FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Jury Clears Sanofi of Liability for Hair Loss From Taxotere Therapy

Oct. 11, 2019

A bellwether trial jury in Louisiana cleared Sanofi of liability over claims that it failed to issue adequate warnings that its chemotherapy drug Taxotere (docetaxel anhydrous) could cause permanent hair loss.

Hundreds of cancer patients sued the drugmaker in a Louisiana federal court for damages in 2016 alleging that the chemotherapy caused their hair loss to be permanent. In December 2015, the FDA required the company to update the drug’s prescribing information to include the risk of persistent alopecia (hair loss) among the drug’s common side effects. 

The bellwether case was filed by Barbara Earnest, who took the drug for breast cancer. Earnest alleged that it prevented her hair from growing back and that she now has permanent hair loss on her head, eyebrows, eyelashes and other areas. Earnest also alleged that Sanofi failed to warn her doctor about the risk of permanent hair loss associated with the drug.

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