Cancer patients shouldn’t avoid Taxotere due to the risk of permanent hair loss (alopecia). However, patients who went bald may be eligible to file a lawsuit. The manufacturer is facing over 700 lawsuits for failing to warn about this side effect until December 2015.
Taxotere Deaths Under Investigation in France
Health officials in Europe are investigating Taxotere after 5 people died of a severe intestinal inflammatory side effect called neutropenic enterocolitis. It is estimated to occur in 1 in 10,000 patients, and it is caused by neutropenia, or low numbers of infection-fighting white blood cells. Neutropenia is the most commonly reported side effect of Taxotere.
800 Taxotere Lawsuits Centralized in MDL
Around 800 Taxotere lawsuits have been filed as of April 2017. In October 2016, judges created a “mass action” to centralize 33 Taxotere lawsuits involving permanent hair loss into one court, under one judge. By mid-December 2016, 250 lawsuits were centralized in Multi-District Litigation (MDL No. 2740) in Louisiana. Hundreds of lawsuits were filed over the next few weeks, nearly tripling the size of the MDL.
What is Taxotere?
Taxotere (docetaxel) is a chemotherapy medication. It is typically given intravenously (IV) in a hospital once every three weeks, sometimes in combination with other drugs. The FDA has approved it to treat the following cancers:
- Breast cancer
- Lung cancer (non-small cell)
- Prostate cancer
- Gastric adenocarcinoma
- Head and neck cancer (squamous cell carcinoma)
FDA Updates Label to Include Permanent Alopecia
After receiving post-marketing reports of patients on Taxotere who developed permanent alopecia, the FDA ordered Sanofi-Aventis to updated the label in December 2015.
Studies Linking Taxotere and Permanent Alopecia
Taxotere is often given to breast cancer patients in combination with Adriamycin (doxorubicin) and cyclophosphamide, a regimen known as TAC chemotherapy. Several studies have compared the rate of permanent hair loss to women who were given FAC chemotherapy, which uses Fluorouracil instead of Taxotere.
In 2006, an independent study by Dr. Scott Sedlacek of the Rocky Mountain Cancer Center found that 6.3% of women who were given TAC grew back less than 50% of their hair. The following clinical trials estimated a 3-9% of women given TAC would experience persistent alopecia:
- GEICAM 9805 was a clinical trial that began the 1990s. By 2005, researchers were aware that 9.2% of patients (49 people) did not regrow their hair during a 10-year follow-up period. In comparison, 6.7% of women on FAC did not re-grow their hair after chemotherapy.
- TAX316 is a clinical trial that compared outcomes for 744 women with breast cancer who were given TAC vs. 736 women who were given FAC. Hair loss occurred in 3.9% of women on TAC vs. 2.2% of women on FAC during the 8-year follow-up period.
Taxotere and Hair Loss
Sanofi-Aventis, the manufacturer of Taxotere, is accused of failing to adequately warn about the risk of permanent hair loss. Until the label was updated in December 2015, the drug-maker reassured women that hair “generally grows back.” According to the original Prescribing Information (PDF) for Taxotere:
“Loss 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.”
Sanofi-Aventis is facing a growing number of lawsuits (PDF) from women who say the drug-maker did not adequately warn about the risk of permanent hair loss. One of the first lawsuits was filed in federal court in Illinois by a woman who says the drug-maker knew or should have known about the risk long before labels were updated.
On March 30, a breast cancer patient from Colorado filed a lawsuit (PDF) accusing Sanofi-Aventis of failing to warn about the risk of permanent hair loss from Taxotere. The woman was diagnosed with cancer in September 2012 and underwent chemotherapy that included Taxotere between February and April 2013. Click here to read more.
In March 2016, Sanofi-Aventis was hit with a federal lawsuit (PDF) in California by a woman who was diagnosed with permanent hair loss (alopecia) after undergoing chemotherapy with Taxotere. The lawsuit was filed in the U.S. District Court for the Northern District of California (Case No. 4:16-cv-01251). Click here to read more.
In January 2016, a breast cancer survivor from Ohio filed a lawsuit (PDF) against Sanofi-Aventis for failing to warn about the risk of permanent hair loss (alopecia) from Taxotere. According to the complaint: “Defendants preyed on one of the most vulnerable groups of individuals at the most difficult time in their lives. … Although alopecia is a common side effect related to chemotherapy drugs, permanent alopecia is not.”
What is the Risk?
Hair loss is a common side effects of chemotherapy, but permanent baldness is not. In general, only a small percentage of cancer experience persistent alopecia. Unfortunately, studies suggest that 3-10% of patients on Taxotere in combination with other chemotherapy drugs experience long-term hair loss.
Chemotherapy and Baldness
Chemotherapy medications destroy all rapidly-growing cells, including cancer cells and healthy cells. The problem is that hair follicles are some of the fastest-growing cells in the body. They divide every 24-72 hours. As chemotherapy destroys cancer, it also causes hair loss.
Cold Caps May Reduce Hair Loss
One way to reduce the amount of hair loss from chemotherapy is with a cold cap. Wearing a tight-fitting, chilled hat constricts blood vessels in the scalp and prevents chemotherapy drugs from reaching hair follicles. Recent clinical trials have also confirmed that scalp-cooling can prevent some hair loss from chemotherapy with Taxotere.
What Can I Expect?
Hair loss usually starts 10-14 days after starting treatment, continues during treatment, and starts growing back 4-6 weeks after the end of treatment. Talk to your doctor about what to expect from the specific chemotherapy drugs you are taking. It can also be useful to talk to other people who have gone through the same treatment.
In April 2016, Taxotere was recalled in the United Kingdom (U.K.) because a manufacturing error may have increased the potency of a small number of batches. A software failure may have allowed some ethanol (alcohol) to evaporate, which could increase the concentration of Taxotere in each vial. Only about 0.09% of the 4 ml vials are estimated to be affected. Click here to read more.
In March 2001, Taxotere was recalled in the United States because the active drug in 20-mg vials may have accidentally been labeled as a “diluent” vial. The recall was issued after one complaint about mislabeling, which drug-makers believe is an isolated event. No adverse events were linked to the problem.
- American Cancer Society: Caring for Patients With Hair Loss
- National Cancer Institute: Alopecia (Hair Loss)
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