Taxotere Permanent Hair Loss Lawsuit

Santa Clara, CA: 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.

The FDA first approved Taxotere in 1996 to treat metastatic and adjuvant breast cancer. Of approximately 2.8 million American women with a history of breast cancer, about 75 percent (more than 2 million women) were prescribed Taxotere to treat their symptoms. Breast cancer is the most common form of cancer in American women, with 183,000 new cases diagnosed each year, and nearly 45,000 subjects die.

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.

In April 2009 the FDA issued a warning letter for a reprint carrier citing a study in the Journal of Oncology, which compared the efficacy of Taxotere and Taxol (brand name for paclitaxel) in treating breast cancer. The agency warned Sanofi of the following:
 

• Promotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience. Furthermore, promotional materials are misleading if they contain representations that the drug is better or more effective than has been demonstrated by substantial evidence or substantial clinical experience.

In a 2010 press release, Sanofi-Aventis reported that Taxotere has been used worldwide to treat more than 1.5 million patients, 100,000 of whom were participants in clinical trials. Five years later, the FDA issued another warning that "Cases of permanent alopecia have been reported". Before the FDA's update in 2015, the Taxotere label stated that hair generally grows back"after completing treatment. But Sanofi's studies indicated that 3 percent of patients experienced persistent or permanent hair loss.
  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: "uch 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.
  Taxotere chemotherapy patients claim that Sanofi-Aventis failed to warn about the risk of permanent baldness, and in doing so, patients were deprived of making an informed decision to choose other chemotherapy drugs, just as effective as Taxotere, without the risk of alopecia. Women in particular who are living with this avoidable condition feel like they are still having to fight cancer.

According to the UK's Mirror.co (Nov 2015), Sanofi said the following: "Hair loss can affect some patients taking anti-cancer medications such as Taxotere. All clinicians are required to discuss the benefits and risks of any treatments with their patients. If any cancer patient has any concerns about hair loss they should discuss it with their clinician." One breast cancer survivor, whose hair didn't grow back six months after receiving Taxotere, told The Mirror that she would "rather have lost my breast than lost my hair."

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 FDA issued a warningin December 2015). Sanofi-Aventis is a French multinational pharmaceutical company based in France.
 

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Last updated on Apr-27-20