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Did Sanofi Warn About Hair Loss from Taxotere?

Did Sanofi Warn About Hair Loss from Taxotere?

April 29, 2016 — Sanofi-Aventis is accused of failing to warn about permanent hair loss from Taxotere in an effort to promote it as superior to other chemotherapy drugs for women with breast cancer.

Taxotere was approved for breast cancer in 1996. It was promoted as superior to its main competitor, Taxol (paclitaxel), despite a lack of evidence. In fact, a study published by the New England Journal of Medicine found the two drugs equally effective at improving survival for women with breast cancer.

In 2009, the FDA cited Sanofi for “false and misleading” marketing and issued a warning (PDF):

“[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.”

The FDA updated the label on Taxotere to include permanent alopecia in December 2015, a decade after warnings were added to labels in Europe. Labels were updated in Canada in 2012.

The original label in the United States also reassured women that “hair generally grows back” once they complete chemotherapy treatment. Sanofi-Aventis recently updated the label to warn: “In most cases, normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”

In clinical trials, researchers found that 9.2% of women with breast cancer who received Taxotere, Adriamycin, and Cyclophosphamide (TAC) experienced persistent hair loss during the 10-year follow-up period. Other studies have estimated that 3-6% of women who receive Taxotere could experience alopecia.

Do I have a Taxotere Lawsuit?

The Schmidt Firm, PLLC is currently accepting Taxotere induced injury cases in all 50 states. If you or somebody you know has been diagnosed with permanent hair loss, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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