TAXOTERE

Taxotere is an intravenous chemotherapy drug developed and manufactured by Sanofi.[1] The FDA approved the drug in 1996 for the treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and prostate cancer.[2]

Taxotere is most commonly associated with the treatment of breast cancer.[3] Breast cancer is a very common form of cancer in the United States—estimated to effect approximately one in 8 American women.[4] There are currently around 3 million women in the United States living with breast cancer, and in 2016 alone, around 246, it is projected that 660 new cases of breast cancer will be diagnosed.[5]

Since its introduction to the American drug market, Taxotere has been an extremely popular choice for women undergoing breast cancer treatments and Sanofi promotes it as the most highly proscribed drug in its class.[6]

Taxotere works similar to other chemotherapy drugs in that it stops cancerous cells from dividing and multiplying by targets the cells’ DNA or RNA.[7] It belongs to a class of drugs called taxanes, which are diterpenes that were made from the bark of the Pacific Yew tree.[8]

Taxotere is typically considered a second line chemotherapy drug, i.e. used in combination with other medications after breast cancer patients did not respond to doxorubicin, which is an anti-cancer drug that works by interacting with DNA “in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase.”[9] It is also used to treat advanced stage breast cancer that has spread to new parts of the breast or the body after the patient has been treated with standard chemotherapy medications, along with early stage breast cancer that has yet to spread to the patients lymph nodes post surgery.[10]

Due to its popularity, Taxotere was a huge moneymaker for Sanofi, bringing the company over $3 billion in sales in 2009, which is the same year that the drug lost its patent protection.[11] Taxotere has been marketed as a more practical drug treatment for women with an active lifestyle since it requires patients to come in for treatment once every three weeks, whereas it’s popular competitor Paclitaxel requires a once weekly treatment schedule.[12] The typical dose of Taxotere ranges from 60 mg/m2 to 100mg/m2 for one hour every three weeks.

However, despite the promoted convenience of Taxotere, the drug has been linked to several side effects. Reported side effects include: low white blood cell count; fever; allergic reaction; fluid retention; rash; numbness in the hands and feet; nail changes; and most significantly, permanent hair loss.[13]

While temporary hair loss during chemotherapy treatments is a very common, many women that took Taxotere were not warned that taking the drug could experience alopecia areata, which is a type of hair loss that cannot be cured and occurs when a person’s immune system mistakenly attacks hair follicles.[14] Nonetheless, on Taxotere’s label warnings, Sanofi assured patients and doctors that while hair loss is a common and regrettable side effect, “hair generally grows back.”[15]  Specifically, Sanofi provided:

“[l]oss of hair occurs in most patients taking Taxotere (including the hair on your head, underarm hair, pubic hair, eyebrows, and eyelashes). Hair loss will begin after the first few treatments and varies from patient to patient. Once you have completed all your treatments, hair generally grows back.”[16]

Despite Saofi’s warning label, as early as the 1990s the company sponsored a GEICAM study to analyze the connection between Taxotere and alopecia areata.[17] By 2005, the GEICAM study revealed that 9.2% of patients using Taxotere suffered from hair loss that lasted 10 years or longer.[18]

A year later, in 2006, Dr. Scot Sedlacek, a researcher a the Rocky Mountain Cancer Center conducted a study that revealed that more than 6% of women suffer permanent alopecia areata while using Taxotere.[19] That same year, Taxotere received a black box warning from the FDA.[20]

In 2011, the Annals of Oncology published the findings of a study that concluded severe alopecia areata was a common complication among women using Taxotere for breast cancer treatment.[21] The study examined the effect of Taxotere on 20 patients and all 20 patients experienced the medical condition.[22] Additionally, a 2013 study by the National Cancer Research Institute found that 10-15% of patients who receive Taxotere as part of cancer treatment experienced permanent hair loss.[23]

Plaintiffs have filed lawsuits against Sanofi-Aventis alleging that the manufacturer intentionally deceived consumers and failed to make users fully aware of the risk of permanent hair loss associated with use of the drug.[24] Plaintiffs allege, among other things, that Sanofi-Aventis sold Taxotere without properly testing it, failed to determine whether the Taxotere was safe for women to use, sold Taxotere without disclosing the dangers or risks associated with the drug, and mislead the public in its advertising and marketing.[25] 

Plaintiffs allege that the permanent loss of their hair after completion of chemotherapy treatment have severely impacted their quality of life. Plaintiffs are quick to point out that the loss of hair is not just simply a vanity issue—it is leading to anxiety, body image issues, sexual dysfunction, and even an inability to return to work.[26] One woman said that her bald head and is a constant reminder to her past struggle with cancer and will always make her look like a cancer patient to the outside world.[27] As of June 2016, only individual Taxotere lawsuits were filed.[28]