April 29, 2016 — In an effort to promote the chemotherapy drug Taxotere as superior to its competitors, Sanofi-Aventis may have downplayed severe side effects like permanent hair loss.
Warnings about permanent hair loss were added to Taxotere labels in Europe and Canada in 2005 and 2012, respectively. However, it was not until December 2015 that permanent alopecia was added to the label in the United States.
After Taxotere was approved in 1996, Sanofi-Aventis aggressively marketed it as superior to Taxol (paclitaxel). These claims were unsubstantiated and recent studies have found mixed results.
In 2008, a study published in the New England Journal of Medicine found no differences in survival between breast cancer patients who were treated with Taxol compared to Taxotere.
In 2009, the FDA sent a warning letter (PDF) about “false and misleading” marketing claims for Taxotere. According to the FDA:
“[Taxotere ads] misleadingly overstate the survival benefits of Taxotere and imply that survival depends on treatment with Taxotere, while also minimizing the serious and potentially life-threatening risks associated with the drug by omitting some risk information and presenting other risk information in an inconspicuous manner.”
Sanofi-Aventis is now facing a growing number of lawsuits from women who were not warned about the risk of permanent hair loss. The company conducted clinical trials in the 1990s in which 9.2% of women who were given Taxotere, Adriamycin, and Cyclophosphamide for breast cancer developed hair loss that persisted during the 10-year follow-up period.
The original label for Taxotere falsely reassured women that “hair generally grows back” after treatment ends. The label now states, “In most cases, normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”
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