Taxotere Deaths Under Investigation in France
French health regulators are investigating Taxotere after 5 people died of neutropenic enterocolitis, aside effect that is estimated to occur in 1 in 10,000 patients. It is caused by neutropenia (low levels of infection-fighting white blood cells). Neutropenia is the most frequently reported side effect of Taxotere.
800 Taxotere Lawsuits Centralized in MDL
Around 800 Taxotere lawsuits have been filed nationwide as of April 2017. The litigation has been growing since October 2016, when judges centralized 33 cases in Multi-District Litigation (MDL No. 2740) in Louisiana. By mid-December 2016, there were more than 250 lawsuits pending in the MDL. Hundreds of new lawsuits were filed over the holidays, nearly tripling the size of the MDL to 705 lawsuits by January 2017.
Taxotere (docetaxel) is an intravenous chemotherapy drug that stops cancer cells from growing and dividing. It is used alone or in combination with other medications. It is normally administered intravenously once every three weeks.
Taxotere and Breast Cancer
Taxotere is primarily used to treat breast cancer. It is used alone for locally advanced or metastatic breast cancer after other chemotherapy treatments failed. It is also used with doxorubicin and cyclophosphamide for operable node-positive breast cancer.
What Other Types of Cancer Does Taxotere Treat?
- Non-Small Cell Lung Cancer (NSCLC)
- Hormone Refractory Prostate Cancer (HRPC)
- Gastric Adenocarcinoma (GC)
- Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN):
Taxotere and Hair Loss
Taxotere can cause hair loss (also known as alopecia). Patients may lose all of their hair, including eyebrows, eyelashes, and body hair. Hair loss typically begins about two weeks after the first treatment. It should start regrowing within 3-6 months after the last treatment ends.
For some patients, hair loss is the most distressing side effect of cancer treatment. In 2010, a study found that 47% of women consider hair loss to be the most traumatic side effect of cancer treatment. The study also found that 8% of women will refuse cancer treatment over fears of hair loss.
What is the problem?
Sanofi-Aventis, the French manufacturer of Taxotere, is under fire from a group of women who accuse the company of failing to warn about permanent hair loss. They say the Prescribing Information (PDF) does not include adequate warnings. In fact, it says the opposite: “Once you have completed all your treatments, hair generally grows back.”
FDA Updates Label to Include Permanent Hair Loss
In December 2015, the FDA updated the label on Taxotere to warn that cases of permanent alopecia had been reported in post-marketing experience.
Taxotere Hair Loss Lawsuits
Sanofi-Aventis is facing a growing number of lawsuits (PDF) from women who were diagnosed with permanent alopecia after undergoing chemotherapy for breast cancer. According to one recent lawsuit:
“Although women might accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer, this was not the case. … [T]here were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia as does Taxotere.”
On March 30, a woman from Colorado with breast cancer who developed permanent hair loss after undergoing chemotherapy with Taxotere filed a lawsuit (PDF) (Case No. 1:16-cv-00714). Click here to read more.
In March 2016, a lawsuit (PDF) was filed by a woman from California who experienced permanent hair loss after undergoing chemotherapy with Taxotere. The lawsuit was filed in the U.S. District Court for the Northern District of California on March 14 (Case No. 4:16-cv-01251). Click here to read more.
In January 2016, a woman from Ohio has filed a lawsuit (PDF) accusing Sanofi-Aventis of failing to warn that Taxotere causes permanent hair loss, also known as alopecia. 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.”
Studies Linking Taxotere and Alopecia
GEICAM 9805 is a clinical trial sponsored by Sanofi-Aventis in the 1990s to study Taxotere in combination with Adriamycin (docorubicin) and Cytoxan (cyclophosphamide). Taxotere was shown to be highly-effective at treating metastatic breast cancer, but 9.2% of patients (49 women) experienced hair loss that persisted during a 10-year follow-up.
Another clinical trial called TAX316 investigated the risk of hair loss in 744 women with breast cancer who were given Taxotere vs. 736 women who were given another chemotherapy regimen. After an 8-year follow-up period, hair loss persisted in 3.9% of women on Taxotere.
In 2006, a study presented by Dr. Scott Sedlacek of the Rocky Mountain Cancer Center found that 6.3% of women who were given Taxotere, Adriamycin, and Cytoxan grew back less than half of their hair.
Other studies have investigated dozens of case reports linking Taxotere and permanent hair loss. One study published in 2012 reported 20 cases of the side effect in women who were treated for breast cancer. Another study published in 2011 found that in some cases, scalp hair grew no longer than 10-cm and had an altered texture.
Will My Hair Grow Back?
Almost all cases of hair loss are temporary. Hair usually starts growing back a couple weeks after the last treatment. However, about 3% of patients who are given Taxotere could experience persistent or permanent hair loss, according to the manufacturer. The risk is higher when Taxotere is used in combination with other chemotherapy drugs, with some studies suggesting the risk could be as high as 6-10% of patients.
Can Hair Loss Be Prevented?
Cold caps — tightly-fitting, chilled hats — are sometimes used during chemotherapy to reduce hair loss. By constricting blood vessels in the scalp, cold caps reduce the amount of chemotherapy drugs that reach the hair follicle.
Why Does Hair Loss Occur?
Chemotherapy stops all rapidly-dividing cells, including healthy cells and cancer cells. Hair follicles are some of the fastest-growing cells in the body. As chemotherapy destroys cancer cells, it also destroys hair cells. This causes hair loss all over the body, not just on the scalp.
What Should I Do?
Do not avoid chemotherapy treatment with Taxotere due to the risk of hair loss. Before starting treatment, talk to your doctor about what to expect. Discuss practical issues like preventing hair loss, caring for your scalp, and your feelings about losing your hair. Each person will find their own way of dealing with treatment, but it can be helpful to talk to other people who have gone through the same experience.
For women who are likely to be cured of their breast cancer, there may be other treatments that do not have the same risks. Taxotere is a powerful drug meant for severe breast cancer, but it is also very toxic. This is why it is a “last-resort” medication that is only used after other treatments have failed, and usually in combination with other chemotherapy drugs.
- April 2016 — Taxotere recalled in the U.K. because a software failure during production may have allowed ethanol (alcohol) to evaporate, which could increase the concentration and potentency of Taxotere in the vial. About 0.09 of the 4 ml vials could be affected. Click here to read more.
- March 2001 — Taxotere recalled in the United States after one report of a 20-mg vial of Taxotere that was mislabeled as a “diluent” vial. Aventis Pharmaceuticals believes the incident is isolated. No adverse events were reported.