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Taxotere (docetaxel) is a popular chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) in 2004 for the treatment of operable node-positive breast cancer. It was subsequently expanded to treat head and neck cancer, prostate cancer, and non-small cell lung cancer.
Approximately 300,000 women are diagnosed with breast cancer in the U.S. each year, and doctors prescribe Taxotere to treat the majority these cases. Taxotere is the most prescribed drug in its class, making over $3 billion for manufacturer Sanofi-Aventis in 2009 before the company lost patent protection.
Taxotere also brought about a troubling adverse reaction: permanent hair loss, otherwise known as Taxotere alopecia. Although the Taxotere label has always contained information about hair loss, there was no suggestion that the side effect could be permanent.
In December 2015, the FDA issued a warning and a subsequent update to the Taxotere boxed warning regarding the drug’s potential for permanent hair loss, and the agency approved the following language for the Taxotere label: “Cases of permanent alopecia have been reported.”
A number of clinical studies have linked Taxotere to permanent hair loss, including:
Breast cancer survivors and their families are filing lawsuits against Sanofi-Aventis, making allegations that the company failed to warn them of the risk associated with Taxotere and hid research linking the drug to its serious side effects.
Approximately 60 Taxotere lawsuits representing women from around the country have been filed in the city of St. Louis. In addition, there are currently more than 30 Taxotere lawsuits pending in 16 federal courts that make similar allegations, including:
The lawsuits also allege that Taxotere maker Sanofi-Aventis warned in its marketing materials that hair loss following chemotherapy is a common side affect, but permanent alopecia is not. The plaintiffs claim that had they known about this side effect of Taxotere, they would have opted for the less potent but equally effective chemotherapy drug Taxol, which has not been linked to permanent hair loss.
Women from the U.S., Canada, the United Kingdom, and France who have formed a support group called, “A head of Our Time” took the chemotherapy drug Taxotere and insist that they were never warned of permanent hair loss. They also charge that the company misled them by assuring them that their hair would grow back after chemotherapy, although it has not.
Permanent hair loss is more than cosmetic – it can have a major effect on a woman’s mental health. The breast cancer survivors, permanent hair loss is a constant reminder of their struggle – for them, life will never be the same and the loss is emotional, physical, as well as financial.
According to a 2004 study on the importance of hair conducted at Arizona State University, hair “is personal, growing directly out of our bodies. It is public, on view for all to see. And it is malleable, allowing us to change it more or less at whim. As a result, it’s not surprising that we use our hair to project our identity and that others see our hair as a reflection of our identity.” Said another way, when women lose their hair, they lose a part of their identity, and every aspect of their lives may be affected.