Sanofi-Aventis is facing a new lawsuit filed over Taxotere, a chemotherapy drug used to treat breast cancer and other forms of cancer. The suit, filed on behalf of a Mississippi woman, alleges that the drug resulted in alopecia, or permanent hair loss. The suit focuses on the alleged lack of warning.
The plaintiff started taking Taxotere after she was diagnosed with Stage III breast cancer in 2013. Her treatment involved chemotherapy and a mastectomy of her right breast. The plaintiff began taking Taxotere around August 2013 and took five more rounds until December 2013.
Chemotherapy in general is known to cause hair loss, among other side effects. This is because chemotherapy agents target fast growing cells in the body. While it is administered in the hopes of killing rapidly growing cancer cells, it affects healthy fast-growing cells as well, such as hair follicles. Hair loss associated with chemotherapy is usually expected to be a temporary side effect, and most patients expect the hair to regrow once treatment is complete, the lawsuit alleges.
The lawsuit alleges that Sanofi-Aventis failed to tell the plaintiff or her health care providers about the risk of permanent hair loss with Taxotere. The complaint states that this side effect occurs in 3 to 8 percent of patients who use the drug. Sanofi-Aventis failed to disclose this information on the drug’s packaging, the lawsuit alleges.
The complaint states that women often choose Taxotere because the treatments are shorter, requiring only 4 to 6 treatments as opposed to 12. The plaintiff, however, alleges that she would have selected a different, equally effective option if she had known about the risk of permanent baldness. The lawsuit alleges that Sanofi-Aventis has known about the risk since 2005, citing a study showing that 9.2 percent of patients suffered alopecia for up to 10 years.
The suit also cites findings from a Denver oncologist who reported that 6.3 percent of his patients taking Taxotere suffered permanent baldness.
In response to the litigation, Laurent-Didier Jacobs, vice-president of medical affairs for Sanofi-Aventis Canada, said, “We fully understand that persistent alopecia may be a burden for patients, but still we consider it’s certainly something which is not life-threatening or is not something which impairs the likelihood of survival. Taking into account the benefit brought by this type of therapy, we think things should be put in perspective.”
Plaintiffs in the litigation assert that the issue stems from a failure to warn about the potential for permanent baldness, and not from the drug’s efficacy in terms of treating cancer. All drugs have side effects, and disclosing information about these side effects helps patients and their doctors make an informed decision by weighing the risks versus the benefits.