Taxotere lawsuits involving the chemotherapy treatment’s alleged association with permanent hair loss are beginning to mount in courts around the U.S. One of the first such cases was filed earlier this year by an Ohio woman who has accused Sanofi-Aventis of concealing this devastating side effect from patients in the U.S.
Taxotere (docetaxel) was first approved by the U.S. Food & Drug Administration (FDA) in 1996 to treat patients with locally advanced or metastatic breast cancer after prior chemotherapy attempts had failed. Its approved indications have since been expanded to include head and neck cancer; gastric cancer, prostate cancer and non-small cell lung cancer.
In December, the FDA announced that the “Adverse Events” section of the Taxotere label had been updated to note that cases of permanent alopecia have been reported in patients treated with the drug. However, according to a Taxotere lawsuit filed in the U.S. District Court, Northern District of Ohio, on January 22, 2016, Sanofi-Aventis added a similar warning to the drug’s European label back in 2005. The Canadian label was updated four years ago.
“Although alopecia is a common side effect related to chemotherapy drugs, permanent alopecia is not,” the lawsuit states. “Defendants, through its publications and marketing material, misled Plaintiff, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back.”
According to court documents, the Ohio lawsuit was filed on behalf of a breast cancer patient who underwent Taxotere chemotherapy in 2004. She he was later diagnosed with permanent alopecia, a disorder in which the immune system attacks the hair follicles, causing the hair to fall out and preventing its regrowth.
The plaintiff alleges that the permanent hair loss she experienced due to Taxotere resulted in mental anguish and psychological damage so severe that she was unable to work. She also claims that the side effect was completely avoidable.
“Before Defendants’ wrongful conduct resulted in thousands of women being exposed to the side effects of TAXOTERE, there were already similar products on the market that were at least as effective as TAXOTERE and did not subject female users to the same risk of disfiguring permanent alopecia as does TAXOTERE,” the complaint asserts.
More than 2.8 million women have been treated for breast cancer in the U.S., and it is estimated that more than 75% have undergone Taxotere therapy as part of their treatment. As such, it is expected that the number of Taxotere lawsuit filings will increase.