Sanofi's chemotherapy drug, Taxotere, is the most widely used breast cancer drug in its class. Doctors prescribe it to as many as 75 percent of breast cancer patients in the U.S. Studies show the drug is effective at extending survival. But, breast cancer survivors who used the drug are finding out they may have an unwanted and disfiguring side effect: permanent hair loss, also called alopecia.
Taxotere (docetaxel) is a chemotherapy drug sold by Sanofi-Aventis. It was originally approved by the U.S. Food and Drug Administration in 1996. Since then, the agency approved the drug to treat a variety of cancers. It is one of the most popular drugs used to treat breast cancer.
About 3 million women in the U.S. are living with breast cancer, according to Breastcancer.org. In 2016, roughly 300,000 women will be diagnosed with the disease. Oncologists use Taxotere in a vast majority of breast cancer patients. Some sources state that up to 75 percent of these women will receive Taxotere as a form of treatment. According to Sanofi, the drug is the most prescribed in its class.
In studies, Taxotere performed better than other drugs in extending survival of breast cancer patients. However, the drug may also have a distressing side effect for breast cancer survivors: permanent hair loss, also called alopecia. In women, the side effect is particularly disfiguring.
Now, Sanofi is facing a growing number of lawsuits filed by women who say the company never warned about the severity and permanence of hair loss. The women claim if they had known the potential for permanent alopecia, they might have made a different choice for treatment.
How Does Taxotere Work?
Like other types of chemotherapy drugs, Taxotere works by stopping cells from dividing and multiplying. Normal, healthy cells stop dividing when they are around similar cells. Cancer cells are damaged and no longer have the ability to stop dividing. This is how cancer continues to spread. Chemotherapy drugs like Taxotere attack the cancer cells’ DNA or RNA so the tumor can no longer copy itself and spread.
Along with another chemo drug called Paclitaxel, Taxotere belongs to a specific class of drug called a taxane. Taxanes are made from plant alkaloids. Specifically, Taxotere is made from the bark of the Pacific Yew tree. It works by inhibiting microtubules within cancer cells. Microtubules are necessary for cell division and replication. When the cell can no longer divide or replicate, it dies.
The FDA approved this drug to treat:
- Breast cancer
- Non-small cell lung cancer
- Advanced stomach cancer
- Head and neck cancer
- Prostate cancer
Permanent Hair Loss Linked to Taxotere
While chemotherapy is known to cause hair loss, most cases resolve in 3-6 months after the treatment is finished and hair completely regrows. Hair loss following chemotherapy is one of the most distressing side effects of treatment. Studies show it has a direct impact on quality of life. Permanent hair loss can be devastating.
Some studies now show that Taxotere can cause permanent, irreversible alopecia. All body hair is affected, including eyebrows, eyelashes and pubic hair.
- The GEICAM 9805 funded by Sanofi, revealed that about 9.2 percent of patients suffered hair loss that lasted 10 years or longer, according to data presented in the lawsuit of Ami Dodson.
- Another study conducted by Dr. Scot Sedlacek of the Rocky Mountain Cancer Centers showed that Taxotere could cause 6 percent of women to suffer permanent alopecia.
- A 2012 study published in the Annals of Oncology by Kluger et al. followed 20 women. 19 of the 20 women who received Taxotere had permanent hair loss including eyebrow and eyelash loss. One patient treated for reoccurring breast cancer previously underwent chemotherapy with different drugs and had complete hair regrowth. After she received Taxotere, she suffered permanent hair loss.
“Considering the increasing role of taxane-based therapies in adjuvant treatment, physicians and patients should be aware of this new distressing side-effect,” wrote authors in the Kluger at al. study.
In addition to the risk of permanent hair loss, this drug has a number of other side effects. Many of these are reversible, though in some cases these complications can be fatal.
The following side effects occurred in more than 30 percent of patients:
- Fatigue and weakness
- Fluid retention
- Hair loss
- Mouth sores
- Nail changes (nails may discolor or fall off)
- Peripheral neuropathy (numbness, tingling in fingers and toes usually associated with nerve damage)
The following side effects occur in 10 to 29 percent of patients:
- Muscle, joint or bone pain
- Low platelets
- Liver problems
Toxic death occurred in about 2 percent (19 out of 965) of metastatic breast cancer patients using Taxotere, according to Warnings and Precautions section of the medication insert. The deaths occurred at a dose of 100 mg/m2. Death occurred in 11.5 percent (7 out of 61) of patients with other tumor types with abnormal liver function.
FDA Black Box Warning
There is a black box warning, the FDA’s most serious warning, for the following conditions:
- Toxic death
- Hepatoxicity (kidney damage)
- Hypersensitivity reactions (rash, low blood pressure and fatal anaphylaxis)
- Fluid retention
The FDA also issued a safety announcement on June 20, 2014 for the alcohol content of the drug. Taxotere can cause feelings of intoxication after treatment and should avoid driving or operating machinery for at least one to two hours after an infusion. Drinking alcohol or taking pain relievers or sleep aids may worsen the effects.
Dosage and Administration
There is no oral pill form of Taxotere, and it is given intravenously. One day before therapy starts, patients take corticosteroid pills to reduce fluid retention and allergic reactions to the drug. This continues for three days. Depending on a patient’s height, weight, type of cancer and general health, the doctor will determine the dose and schedule of chemotherapy.
Average Dosage in Breast Cancer Patients
According to the drug’s medication insert, the average dose range is:
- 60 mg/m2 to 100 mg/m2 intravenously over one hour every three weeks. This recommended dose is specifically for patients with locally advanced breast or metastatic breast cancer whose tumors did not respond to other types of chemotherapy.
- For cancer that has spread to the lymph nodes, but is still operable, the dosage increases to 75 mg/m2 administered 1 hour after taking other chemotherapy drugs called doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses.
Your doctor may adjust the dose or stop treatment if:
- The patient develops febrile neutropenia, a condition with a high fever and other signs of infection. This happens when white blood cell counts drop very low because of chemotherapy.
- The patient develops severe skin reactions.
- The patient experienced severe nerve damage called peripheral neuropathy. This is usually numbness, weakness or pain in the hands or feet.
- The patient develops a sore, inflamed mouth and lips that interfere with the ability to talk, eat or sleep.
Doctors will first try to reduce the dose, but if the symptoms worsen or continue at lower doses, the treatment should be discontinued.
In case of a possible overdose, patients need to be monitored and given granulocyte-colony stimulating factor (G-CSF). G-CSF is a protein that causes the bone marrow to produce stem cells and white blood cells and release them into the blood stream. These cells will help prevent infection and fever.
In animal studies, mice died after a dose about 4.5 times a human dose of 100 mg/m2. Male and female rats died at a human dose of 100 mg/m2.
According to the medication insert, two overdoses were reported in patients. Both patients experienced asthma, skin reactions and tingling or prickling of the skin. But, they both recovered.
Hair Loss Lawsuits
As a result of the hair loss side effects of Taxotere, several women are coming forward and filing lawsuits against Sanofi. They say the drug maker failed to warn them of the serious side effect and hid it from the public.
In addition, lawsuits accuse Sanofi-Aventis of failing to disclose research from their company-sponsored GEICAM 9805 study that provided evidence of permanent hair loss. The company also failed to provide instructions on how to reduce the risk of permanent alopecia.