Women Were Never Warned About Risk of Permanent Baldness with Taxotere, Suits AllegeAug 1, 2016
Taxotere is a chemotherapy drug that is commonly used to treat breast cancer. Studies show that the drug, which is manufactured by Sanofi-Aventis, is effective at extending patient survival. However, some patients have taken issue with a particular side effect: permanent hair loss, or alopecia. In fact, Sanofi is facing a growing number of lawsuits alleging they failed to disclose this side effect.
The U.S. Food and Drug Administration (FDA) approved Taxotere in 1996. Similar to other chemotherapy drugs, it works by stopping uncontrolled cell growth. Taxotere is derived from the bark of the Pacific Yew tree and stops cells from dividing by inhibiting its microtubules, proteins essential to cell division and replication.
Hair loss is a known side effect of chemotherapy. In most patients, however, the hair regrows in three to six months. Plaintiffs filing Taxotere lawsuits allege they suffered permanent, irreversible baldness. They also allege that Sanofi never warned about the risk of alopecia, and claim that they would have considered a different treatment if they were fully informed of the risks.
The hair loss associated with Taxotere use affects all body hair, including the eyebrows, eyelashes, and pubic hair. Studies have shown that the drug may lead to permanent hair loss in some patients. According to data from the GEICAM 9805 study, which was funded by Sanofi, 9.2 percent of patients taking the drug suffered from hair loss lasting at least 10 years. In another study conducted by a researcher at the Rocky Mountain Cancer Centers, six percent of women taking Taxotere suffered alopecia.
The Annals of Oncology published a 2012 study showing that 19 of 20 women taking Taxotere suffered hair loss. The authors made note of one woman who previously underwent chemotherapy with different drugs to treat recurring breast cancer. Without other medications, she suffered hair loss that resolved. After taking Taxotere, her hair loss was permanent. The authors indicate that it was important to be aware of these risks, stating "Considering the increasing role of taxane-based therapies in adjuvant treatment, physicians and patients should be aware of this new distressing side-effect."
In San Diego, a lawsuit was recently filed on behalf of a woman who alleges she was never warned about the risk of permanent baldness with Taxotere. According to the lawsuit, the FDA issued a 2009 letter to Sanofi alleging, "false or misleading statements concerning unsubstantiated claims of Taxotere’s superior efficacy." The lawsuit claims that Sanofi knew about the risk of permanent baldness since 2005, citing data from one of the company's own studies. The lawsuit also points out 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.