Parker Waichman LLP

Taxotere and the Risk of Alopecia

The U.S. Food and Drug Administration (FDA) approved Taxotere as a chemotherapy drug in 1996. Taxotere is manufactured by Sanofi-Aventis and is commonly used to treat breast cancer, as well as other cancers. Some patients taking Taxotere have reported experiencing permanent hair loss, or alopecia. In December 2015, the FDA warned that Taxotere was linked […]

The U.S. Food and Drug Administration (FDA) approved Taxotere as a chemotherapy drug in 1996. Taxotere is manufactured by Sanofi-Aventis and is commonly used to treat breast cancer, as well as other cancers. Some patients taking Taxotere have reported experiencing permanent hair loss, or alopecia. In December 2015, the FDA warned that Taxotere was linked to cases of permanent alopecia. The drug label was updated to reflect this information.

Chemotherapy itself can lead to hair loss. This is because chemotherapy drugs such as Taxotere target rapidly dividing cells in the body, which stops the growth of cancer cells as well as other fast-growing cells such as hair follicles. In most cases, hair loss from chemotherapy is transient. Taxotere use has been linked to cases of permanent baldness.

Sanofi-Aventis is facing lawsuits filed by patients who allege that they were never warned about the risk of permanent hair loss with Taxotere. One lawsuit, recently filed in San Diego, alleges that the company has been aware of the risk of baldness since 2005. The complaint cites data from one of the company’s own studies to support this claim. The lawsuit also alleges that Sanofi was aware of warnings for permanent baldness in Canada and Europe, but the label in the United States was not updated until last January.

Sanofi funded a study called the GEICAM 9805 study, which found that 9.2 percent of patients taking Taxotere suffered from hair loss lasting at least 10 years. A researcher at the Rocky Mountain Cancer Centers also published a study, finding that six percent of women experienced alopecia.

The Annals of Oncology published a study evaluating hair loss in women using Taxotere. The authors noted “Considering the increasing role of taxane-based therapies in adjuvant treatment, physicians and patients should be aware of this new distressing side-effect,” Of the 20 women who took Taxotere in the study, 19 developed hair loss. Researchers noted one woman who previously underwent chemotherapy with different drugs to treat recurring breast cancer; she had suffered temporary hair loss in the past. After taking Taxotere, the hair loss was permanent.

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