While litigation over the side effects of Taxotere (aka docetaxel)—including alopecia, or permanent hair loss—have been going on for some time now, in October and November, updates were made to the warning labels for the product and new studies were done on its effectiveness, as we discuss below.
What Is Taxotere, And How Does It Work?
Taxotere is a chemotherapy drug approved by the Federal Drug Administration (FDA) to treat certain cancers, such as breast cancer, head cancer, neck cancer, non-small cell lung cancer, and prostate cancer. The drug works by exhibiting antineoplastic properties—binding to and stabilizing tubulin—and resulting in cell-cycle arrest and cell death. It is used either on its own or its combination for treating not only breast cancer, but also advanced adenocarcinoma of the stomach or gastroesophageal junction, non-small cell lung cancer, metastasized prostate cancer, and locally-advanced squamous cell carcinoma of the head and neck. One of the main purposes of the drug is to “make the chemotherapy process smoother” for those who are undergoing it. In other words, it is supposed to speed up the process of recovery so that patients do not have to go through cancer treatments as long, overall.
Common side effects of Taxotere include allergic reactions, fatigue, fluid retention, hair loss, low blood cell count, muscle pain, and nausea. Others include allergic reactions, anemia, bruising, diarrhea, discolored fingernails, fatigue, fluid buildup, hair loss, numbness, redness and peeling on hands and feet, soreness, sore mouth, tingling in the hands and feet, and watery eyes.
The company that produces the drug—Sanofi (also known as “Sanofi-Aventis”)—is currently facing close to 8,000 pending lawsuits over false marketing and the severe side effects associated with the drug. Although patients were warned about some side effects in taking the drug, a number have alleged that the company downplayed their severity and falsely marketed the drug as more effective than other chemotherapy treatments.
Severe Hair Loss & Alopecia Concerns
While hair loss is a common side effect of going through chemotherapy, permanent hair loss (i.e. alopecia) is not. Studies have demonstrated that Taxotere contributes to permanent hair loss in cancer patients, whereby—even after undergoing treatments to stimulate hair growth—very little improvement is seen. Specifically, women who have used Taxotere for six months now claim that this was long enough to leave them with permanent hair loss and alopecia—i.e. they can no longer grow new hair at all. The drug did not feature any sort of warning with respect to alopecia. As a result of this, these patients experienced significant trauma and negative impacts on the quality of life, including an increase in anxiety, low self-esteem, poor body image, and difficulties transitioning back into everyday life and/or work. 40 percent of patients who experienced alopecia as a result reported extremely poor quality of life, and 70 percent reported actively working to hide their alopecia.
Allegations: Hiding Information, Misleading Advertising, Inadequate Testing, Failure to Warn, and More
Even though Taxotere entered the market around 1995 and was approved by the Food and Drug Administration (FDA) in 2004, warnings about potential side effects including alopecia were not released by manufacturers until around 2015. This was still the case even though Sanofi funded a research study in 1998 that showed the potential for permanent baldness. That same study not only revealed that 9.2 percent of women in the study experienced hair loss due to the treatment, but that Taxotere was much more toxic than the alternative treatment regime—fluorouracil (Adrucil)—which many experts argue is superior to Taxotere. Still, manufacturers failed to notify American distributors in the U.S. Some even claim that they offered bribes and trained employees to actively misrepresent the drug’s effectiveness and safety; all while warnings began to pop up in other parts of the world, including Europe; and the use of Taxotere expanded and was also prescribed to patients with cervical and ovarian cancer; all because manufacturers of the drug continued to maintain that it was superior.
October 2018: New Warning Issued
On October 5, the FDA approved an update to the Warnings and Precautions section of the Taxotere drug label regarding risk of enterocolitis (inflammation of the mucosa of the colon and small intestine) and neutropenic colitis. The update recommends caution for patients with neutropenia, especially those at risk for developing gastrointestinal complications. It also notes that enterocolitis and neutropenic enterocolitis can develop at any time and could lead to death as early as the first day of symptoms. Any patients that exhibit symptoms of gastrointestinal toxicity are advised that they should be closely monitored.
This warning update arguably took a considerable amount of time, given that, in February 2017, fatal neutropenic enterocolitis, in conjunction with the use of docetaxel, was reported in patients in France. As a result, the Institute Curie in Paris stopped using docetaxel altogether and instead replaced it with paclitaxel.
November 2018: Mixed Results as Head & Neck Cancer Treatment
In addition, on November 7 of this year, medical sources reported that intensified treatment strategies including Taxotere for advanced head and neck squamous cell carcinoma (HNSCC) had “hit a miss” in randomized trials. The trial examined different strategies to improve outcomes with current therapeutic standards for locally advanced HNSCC. Investigators randomized the patients to standard treatment induction chemotherapy with Taxotere-cisplatin-fluorouracil, followed by radiotherapy. After a follow up of close to three years, the data showed no difference in improvement on progression-free survival (PFS) for the control group versus the group that received treatment.
Contact Our Attorneys to Discuss Your Taxotere Concerns
Individuals who have experienced harm from using Taxotere may be eligible to file claims against the manufacturer. Contact the Roger Ghai Law Offices to schedule your free case evaluation and find out more.