A woman from Mississippi who permanently lost her hair after being treated with Taxotere has filed a lawsuit against Sanofi-Aventis.
The lawsuit was filed in the U.S. District Court for the Southern District of Mississippi (Jackson Division) on June 2, 2016 — Case No. 3:16-cv-00412.
The plaintiff, Christine Tolefree, was diagnosed with cancer in her right breast in May 2014. When discussing treatment, she was never warned her about the risk of permanent baldness from Taxotere.
Almost everyone who goes through chemotherapy loses their hair, but permanent hair loss is not normal. After undergoing chemotherapy with Taxotere, her hair did not grow back and she continued to suffer from disfiguring baldness in early 2016.
Taxotere is a powerful chemotherapy drug made by Sanofi-Aventis that was approved for breast cancer in 1996. It is more potent than other taxane-based drugs, such as Taxol, but also more toxic.
In 2005, a study found that 9.2% of patients treated with Taxotere, Adriamycin, and Cyclophosphamide (TAC regimen) had hair loss that persisted during the 10-year follow-up period. Other studies have estimated a 3-6% risk of permanent baldness from Taxotere.
The FDA updated the label on Taxotere to include permanent alopecia in December 2015. Evidence of the side effect had been growing for over a decade.
Before the updates, Sanofi-Aventis reassured women that hair “generally grows back” after treatment. Now the label says, “In some cases (frequency not known) permanent hair loss has been observed.”
The FDA has also issued warnings to Sanofi-Aventis for “false and misleading” ads for Taxotere that overstated its benefits and minimized risk information.
Source: A Head of Our Time