Lawsuits are being filed over Taxotere, a chemotherapy drug manufactured by Sanofi-Aventis. Plaintiffs allege that they were never warned about the risk of permanent baldness when taking the drug, claiming they would have considered a different option if they were fully informed. Taxotere was approved by the U.S. Food and Drug Administration (FDA) in 1996. It is a common treatment for breast cancer, and is also used for other types of cancer.
As with other chemotherapy drugs, Taxotere works by stopping the rapid growth characteristic of cancer cells. The drug is derived from the bark of the Pacific Yew tree and inhibits microtubules, proteins necessary for cell division and replication. Studies have shown that Taxotere is effective at extending patient survival. When it comes to a disease such as cancer, patient survival is naturally of utmost importance. Lawsuits filed over Taxotere focus on the lack of warning for permanent hair loss.
Chemotherapy is known to cause temporary hair loss. Most cases resolved in three to six months. The hair loss associated with Taxotere use, lawsuits allege, is permanent. Plaintiffs say they would have considered a different, equally effective drug if they knew about the risk of permanent hair loss.
A lawsuit was recently filed in San Diego alleging Sanofi-Aventis never warned about the risk of permanent hair loss with Taxotere. According to the lawsuit, the FDA issued a 2009 letter to the company citing “false or misleading statements concerning unsubstantiated claims of Taxotere’s superior efficacy.” The suit 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.
Patients who suffer from alopecia following the use of Taxotere experience hair loss on the entire body, including the eyebrows, eyelashes and pubic hair. Lawsuits cite data from the GEICAM 9805 study, which was funded by Sanofi, showing that 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.
In 2012, the Annals of Oncology published a study following 20 women who took Taxotere. Among them, 19 developed hair loss. According to the study, there was 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. The authors said 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,”