Chemotherapy Agent, Taxotere, Associated with Permanent Hair Loss. Taxotere (docetaxel) is a breast cancer medication marketed by Sanofi-Aventis and is often administered in collaboration with other cancer drugs. Since its approval by the U.S. Food and Drug Administration in 1996. Taxotere has also received clearance for head and neck, gastric, prostate, and non-small cell lung cancer. In December 2015, the drug label was updated to indicate that cases of permanent alopecia (hair loss) had been reported among chemotherapy patients treated with Taxotere. Over 250,000 cases of breast cancer are diagnosed annually; Taxotere is a chemotherapy agent used in 75 percent of all breast cancer patients.
Hair loss is a well-known side effect of chemotherapy and Taxotere is likelier to lead to permanent alopecia than other chemotherapy drugs. Personal injury law firm, Parker Waichman LLP, notes that individuals who experienced Taxotere hair loss may be eligible to file a Drug lawsuit.
Patients undergoing Taxotere treatment were led to believe that their potential Taxotere alopecia would be temporary; however, it seems that Taxotere may increase risks for permanent hair loss. In response, in December 2015, the U.S. Food & Drug Administration (FDA) updated the Taxotere label to warn about potential of permanent hair loss in the “Adverse Reactions” section that now states that, “Cases of permanent alopecia have been reported.”
A mounting number of women nationwide, from Canada, and from the United Kingdom are increasingly discussing their stories of Taxotere permanent baldness. One woman told The Globe and Mail in 2010 that, “They absolutely told me my hair will grow back,” adding that, “I will never be well of breast cancer because of this. My life is not over, but my life is drastically changed.”
Another breast cancer patient told the same media outlet that year that, “There never seemed to be any doubt that my thick, shoulder-length auburn hair-my crowning glory-would grow back” She said that, “I wore scarves and hats quite happily until I finished treatment in early 2006 and waited patiently for my hair to appear-yet it only came back in an extremely sparse way that resembles male-pattern baldness and means that I have to regularly shave my head because it looks even worse than having no hair at all.”
The women alleged to have never been warned about the potential for permanent hair loss with drug treatment, which did not enable them to make a more informed choice about their cancer treatment.
Also, recent research also suggests that Taxotere may lead to permanent alopecia in some patients. A 2013 survey conducted by the Clatterbridge Cancer Center in the United Kingdom found that permanent alopecia may impact 10-15 percent of breast cancer survivors who received treatment with Taxotere. In 2010, research published in the Journal of the American Academy of Dermatology pointed out that, “an increasing number of permanent chemotherapy-induced alopecia” were thought responsible due to Taxotere treatment. One study published by the Rocky Mountain Cancer Center revealed that 6.3 percent of Taxotere patients may experience the permanent reaction.
Taxotere Hair Loss Lawsuits Mounting
To date, scores of Taxotere hair loss claims are pending in the centralized proceeding underway in the Eastern District of Louisiana. Plaintiffs similarly allege that hair loss, which is a common side effect of chemotherapy, is likelier to be permanent with Taxotere when compared to other chemotherapy medications with similar efficacy. The multidistrict litigation (MDL) has been organized under District Judge Lance M. Africk.
Some argue that Sanofi-Aventis, knew about Taxotere’s permanent hair loss risk as far back as 2004. Plaintiffs allege that Sanofi-Aventis had long warned patients and the medical community in the European Union and in Canada that Taxotere may cause permanent, disfiguring hair loss, while American doctors and their patients were not warned for another ten year and the U.S. label then merely stated that “hair generally grows back” following the use of Taxotere.
Court records indicate that the proceeding’s first Status Conference convened November 10th and was followed by two new Orders being issued: One, dated November 16th, stipulates that applications for Special Counsel for Settlement Negotiations be emailed to chambers no later than December 5, 2016; the second, dated November 17th, established the litigation’s leadership structure, including Plaintiffs’ Liaison Counsel and the Plaintiffs’ Steering Committee.
In a recent lawsuit, a woman diagnosed with Stage 2 breast cancer in 2009 was treated with the chemotherapy drug, Taxotere. The woman, although cancer-free, remains permanently disfigured due to the chemotherapy agent. Her concern, and the concern of other women treated with Taxotere, is that there are other equally effective chemotherapy agents available that do not cause permanent hair loss. The woman said that, had she been aware of Taxotere’s permanent hair loss side effect, she would have chosen and alternate treatment. She said that her permanent hair loss is a constant reminder of her breast cancer fight.
An Oklahoma woman treated with the drug, who is also now cancer-free, was left with permanent hair loss. “I never was a girly girl,” she said. “My hair was the one thing I knew could make me look more like a girl.” She said she knew that when she went through breast cancer treatments in 2010 that chemotherapy would cause her thick brown hair to fall out. She believed her hair would grow back. “People look and they have a sympathy look,” she said. “I look like I have cancer,” despite that she has been cancer-free for nearly six years. She said she was advised that Taxotere would lead to permanent hair loss, but noticed a post on social media about permanent Taxotere hair loss.
For its part, Sanofi Aventis seems to be blaming the FDA for the amount of time it took to get a warning on the label. The drug maker wrote, in part to News 9, that, “As early as 2004, Sanofi submitted data about persistent alopecia (or hair loss) to the FDA as part of a proposed drug label update. In December 2015, following discussion between FDA and Sanofi, the label was updated to reflect that cases of permanent alopecia have been reported following use of the drug, although at an unknown frequency. We encourage you to speak with the FDA regarding the timeline of the label update.”
The media outlet contacted the federal regulators who responded by saying that it was not contacted until last year by about permanent hair loss associated with drug use. The FDA indicated that, after some research, it changed the warning label. The FDA would not comment on what occurred prior to 2015 and would only state that labeling updates are an ongoing process.