July 12, 2016 — A woman who did not re-grow her hair after undergoing breast cancer chemotherapy with Taxotere has filed a lawsuit against Sanofi-Aventis for failing to warn about the risk.
The lawsuit (PDF) was filed on June 28 in the U.S. District Court for the Northern District of Illinois (Case No. 1:16-cv-6754).
The plaintiff, Renita Johnson, is a woman from Illinois who underwent a lumpectomy to remove breast cancer in October 2011. Afterward, she met with her oncologist to discuss treatment options to prevent the cancer from coming back.
Until recently, Johnson had no reason to suspect that Taxotere was responsible for her baldness. The FDA did not add warnings to the label until December 2015. The label on Taxotere now states:
“In most cases, normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”
In the last few months, dozens of lawsuits have been filed by people who accuse Sanofi-Aventis of downplaying the risk of permanent hair loss from Taxotere. Before the warnings were updated, the label reassured women that “hair generally grows back” after treatment.
In clinical trials, 9.2% of women with breast cancer who received Taxotere, Cyclophosphamide, and Adriamycin (TAC regimen) had hair loss that persisted in the 10-year follow-up period.
In 2009, the FDA warned the drug-maker about “false and misleading” ads for Taxotere that did not include risk information. The agency also warned Sanofi-Aventis against promoting Taxotere as superior to Taxol.
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