Taxotere Hair Loss in Canada

Taxotere (generic name docetaxel) is a chemotherapy drug used in the treatment of certain cancers, including breast cancer. One drug side effect includes permanent hair loss, called alopecia. Taxotere lawsuits have been filed against Sanofi-Aventis, the manufacturer, claiming the drug company failed to warn of Taxotere hair loss. Canadian women first reported Taxotere alopecia to Health Canada in 2010.

Health Canada approved Taxotere in 1995 to treat locally advanced or metastatic breast cancer and non-small cell lung cancer after failure of prior chemotherapy. According to Sanofi-Aventis, the manufacturer, the new drug submission was based on clinical trials involving more than 800 patients worldwide. In 2005 it received approval from the Canadian Health Protection Branch to treat metastatic prostate cancer in men. The FDA first approved taxotere in 1996.

In 2012 Health Canada was alerted by Sanofi-Aventis to the risk of permanent hair loss from Taxotere. (Sanofi-Aventis allegedly failed to notify the FDA until late winter in 2015.) In 2010, the Globe and Mail reported that three Canadian women lodged complaints of alopecia caused by Taxotere to Health Canada. One Canadian oncologist said that she gives her patients a choice of whether to undergo 12 cycles of Taxol with a “tiny” risk of permanent hair loss, versus four cycles of Taxotere and a heightened risk of permanent hair loss: fewer chemo treatments, but with a greater risk of Taxotere alopecia.

CBC News interviewed one of the three women who allegedly suffered permanent hair loss as a result of Taxotere. Cynthia MacGregor said she was not warned by her medical team that she could lose hair permanently. Instead, she expected her hair to grow back after Taxotere therapy, as was stated on a pamphlet she was given at Royal Victoria Hospital in Montreal where her treatment took place. The seven-page pamphlet was created by the Quebec Association of Pharmacists of Health Institutions and states: "Total loss of body hair will occur. However, don't worry — your hair will grow back.” ( McGregor’s complaint, along with two other Canadian patients, led to an investigation by Health Canada.)

The lawsuits filed against Sanofi-Aventis (the manufacturer of Taxotere) claim the company failed to warn of the increased risks of permanent alopecia (loss of hair). Taxotere chemotherapy patients claim that if the manufacturer had properly warned of the risks, patients would have been prescribed a different chemotherapy drug (such as Taxol), which is just as effective but does not result in permanent hair loss. Women in particular who are living with this avoidable condition feel like they are still having to fight cancer.

The side effect of persistent alopecia is listed on the product monograph since December, 2006, says Laurent-Didier Jacobs, vice-president of medical affairs for Sanofi-aventis Canada.

A Taxotere lawsuit was filed against Sanofi-Aventis in the U.S. District Court for the Northern District of Ohio. Hattie Carson, who was diagnosed with breast cancer in 2004 and underwent chemotherapy with Taxotere, claims that it caused her permanent baldness and the manufacturer failed to adequately warn female breast cancer patients and doctors about the risk of permanent baldness from Taxotere. Carson's lawsuit states that, “Although alopecia is a common side effect related to chemotherapy drugs, permanent alopecia is not. Defendants, through its publications and marketing material, misled Plaintiff, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back.”

Carson further claims that Sanofi-Aventis warned doctors and patients in Europe in 2005 and in Canada in 2012 about the risks of permanent hair loss from Taxotere side effects, but failed to provide such warnings to the U.S. patients and doctors until January 2016.

The BC Cancer Agency Cancer Drug Manual (May 2012 Revised: 1 April 2013, 1 July 20) states the following regarding Docetaxel:

Hair loss, including on the head, eyebrows, eyelashes, pubic area, and underarm, occurs in most patients. Alopecia has a sudden onset, and occurs 14-21 days after treatment has begun. Hair should grow back once treatment has been completed; however, cases of poor hair re-growth and/or persistent hair loss have been reported. Reports suggest some patients may experience prolonged hair loss lasting beyond 24 months, and possibly irreversibly.

When breast cancer is detected early on, or even if it is found to be in its late stages, chemotherapy drugs are generally considered one of the most common and effective forms of treatment. One of the most common treatments is the drug combination of Adriamycin and Taxotere. The chemo drug can also be prescribed to treat prostate cancer, non-small cell lung cancer, advanced stomach cancer and head and neck cancer. Taxotere (other brand names are Docefrez, and Docetaxel Injection) works by interfering with the growth and spread of cancer cells in the body.

Canada Breast Cancer Statistics – BC Cancer Agency

• A woman’s risk of developing breast cancer at any point in her lifetime is about one in nine, and 1 in 29 women will die from it
• In 2015, about 25,000 Canadian women will be diagnosed with breast cancer and 5,000 will die from it.
• Approximately 68 Canadian women will be diagnosed with breast cancer every day
• Approximately 14 Canadian women will be die of breast cancer every day

Canada Taxotere Statistics

• In 2009, about 10,000 patients, including an estimated 6,500 with breast cancer, were treated with Taxotere, according to the Globe and Mail.
• The side effect of persistent alopecia (hair loss) is suffered by about 3 per cent of patients who take Taxotere with other chemotherapy drugs, according to Sanofi-Aventis’ own studies. A different study suggests the incidence of persistent alopecia could be as high as 6 per cent.)
• Canadian hospitals and drug stores spent $70.4-million on Taxotere in 2009, according to IMS Health Canada, a private company that tracks prescription-drug sales.

2006: A study by Dr. Scot Sedlacek at the Rocky Mountain Cancer Centers in Colorado found that 6.3 percent of breast cancer patients grew back less than 50 percent of their hair after they were given Taxotere in combination with Adriamycin (docorubicin) and Cytoxan (cyclophosphamide). The study concluded: “Such an emotionally devastating long-term toxicity from this combination must be taken into account when deciding on adjuvant chemotherapy programs in women who likely will be cured of their breast cancer.”

2010:: A study by the Journal of the American Academy of Dermatology warned about “an increasing number of reports of permanent chemotherapy-induced alopecia,” and blamed Taxotere for some of the cases.

2013: A study published by the National Cancer Research Institute found permanent hair loss as a side effect in 10-15 percent of patients who took Taxotere.

Balding women from Canada, the US and Europe are calling themselves the “Taxotears”. They include one Taxoterrorist, the nickname for Ms. Ledlie, of Brittany, France. She posted pictures of her balding head on the Facebook page of the manufacturer, Sanofi. “We want every woman who’s been offered Taxotere to know it is a possibility, so it is her choice whether to take the risk or not,” Ms. Ledlie said.

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Last updated on Sep-9-16