The following is a list of frequently asked questions (FAQ) about Taxotere, a chemotherapy drug that has been associated with reports of permanent baldness (alopecia).
Frequently Asked Questions
Overview
What is Taxotere?
How does Taxotere work?
Who makes Taxotere?
What does Taxotere treat?
What are severe side effects of Taxotere?
What are common side effects of Taxotere?
Taxotere and Hair Loss
Why does Taxotere make your hair fall out?
What can I expect during treatment?
Does Taxotere cause permanent alopecia?
Is Taxotere hair loss permanent?
What studies have linked Taxotere and permanent baldness?
Does Taxotere Always Cause Hair Loss?
Can Rogaine Cure Taxotere Hair Loss?
Taxotere Warnings
Has the FDA issued warnings about Taxotere marketing?
Did Sanofi-Aventis fail to warn about hair loss?
Has Taxotere been recalled
What is Taxotere?
Taxotere is the brand-name for docetaxel, an intravenous (IV) drug. It belongs to the taxane family of chemotherapy medications, which also includes Taxol (paclitaxel).
How Does Taxotere Work?
Taxotere works by inhibiting tubilin, which is a protein that is essential for cell division. This prevents cancer cells from dividing and growing. It was developed from a compound found in needles of the European yew tree.
Who Makes Taxotere?
The pharmaceutical company Sanofi-Aventis makes Taxotere. It has been on the market since 1996 when it was approved for breast cancer. About 75% of breast cancer patients (more than 2 million women) have been given Taxotere.
What Does Taxotere Treat?
- Head and neck cancer: Taxotere was approved on October 18, 2006 for use in combination with cisplatin and fluorouracil for inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).
- Gastric cancer (stomach cancer): Taxotere was approved on March 22, 2006 for use in combination with cisplatin and fluorouracil for advanced gastric adenocarcinoma after prior chemotherapy failed.
- Breast cancer: Taxotere was approved on May 14, 1996 for locally advanced or metastatic breast cancer in patients who have progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy. Taxotere was also approved on June 22, 1998 for locally advanced or metastatic breast cancer in patients who failed prior chemotherapy. It is often used in combination with doxorubicin and cyclophosphamide for breast cancer, a combination known as TAC. Taxotere is also sometimes used with fluorouracil and cyclophosphamide (a combination known as FAC).
- Prostate cancer: Taxotere was approved by the FDA on May 19, 2004 for use in combination with prednisone (a steroid) for the treatment of advanced metastatic prostate cancer.
- Non-small cell lung cancer: Taxotere was given fast-track approval on December 23, 1999 for patients with advanced or metastatic non-small cell lung cancer. It was also approved on November 27, 2002 for use in combination with cisplatin.
What Are Severe Side Effects of Taxotere?
The Prescribing Information (PDF) for Taxotere has a “Black Box” warning label highlighting many severe and potentially life-threatening side effects. The label also includes Warnings & Precautions for severe side effects, including:
- Permanent alopecia
- Acute myeloid leukemia in patients treated with Taxotere in combination with doxorubicin and cyclophosphamide (TAC).
- Skin reactions, including severe skin toxicity, patchy redness, and swelling followed by skin loss can occur.
- Neurologic reactions, including loss of sensation, abnormal sensations, and pain.
- Eye disorders including Cystoid Macular Edema (CME).
- Physical weakness or lack of energy (asthenia)
- Alcohol intoxication can occur from injections of Taxotere, which can impair a person’s ability to drive or use machines.
- Pregnancy risks include fetal harm
What Are Common Side Effects of Taxotere?
The most common side effects of Taxotere are hair loss (alopecia), infections, low white blood cell count, low red blood cell count, hypersensitivity reactions, nerve damage, foul taste in the mouth, breathing trouble, constipation, weight-loss, nail disorders, fluid retention, physical weakness, lack of energy, pain, nausea, diarrhea, vomiting, skin reactions, and muscle pain.
Why Does Taxotere Make Your Hair Fall Out?
Chemotherapy drugs destroy all rapidly-dividing cells, including cancer cells and healthy cells. Hair follicles divide every 23-72 hours and they are destroyed during chemotherapy. Unlike cancer cells, hair follicles normally repair themselves, making side effects temporary. While temporary hair loss is a normal side effect of chemotherapy, permanent baldness is not.
What Can I Expect During Treatment?
During chemotherapy, it is normal for hair to fall out all over your body — scalp, eyelash, eyebrow, armpit, pubic, and other body hair. Hair loss typically starts within 2-4 weeks after you start treatment and increases during the first two months.
Hair may become slowly thinner or fall out suddenly in large clumps. You may notice hair on your pillow, in your comb, or in your sink and shower drain. You scalp may feel itchy or sensitive.
After treatment, hair loss may continue for a few weeks. It can take 3-6 months before hair begins growing back. When it does, the color or texture may be slightly different. It may be curlier than normal or gray until pigment cells regenerate.
Does Taxotere Cause Permanent Alopecia?
In December 2015, the FDA updated the label on Taxotere to include permanent alopecia — a decade after similar warnings were placed on Canadian drug-labels in 2005. Before the updates, the label reassured American women that “hair generally grows back.”
Is Taxotere Hair Loss Permanent?
During clinical trials, 74% of breast cancer patients on Taxotere experienced hair loss. The label now states that “In most cases, normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”
What Studies Have Linked Taxotere and Permanent Baldness?
In the 1990s, Sanofi-Aventis sponsored a study known as GEICAM 9805 to evaluate Taxotere in combination with other drugs for the treatment of metastatic breast cancer. By 2005, 9.2% of patients (49 women) had hair loss that persisted during the 10-year follow-up period.
Another clinical trial called TAX316 compared outcomes for 744 women with breast cancer who were given the TAC chemotherapy regimen (Taxotere, Adriamycin, and Cyclophosphamide). Outcomes were compared to 736 women who were given Fluorouracil instead of Taxotere (FAC chemotherapy). Hair loss occurred in 3.9% of women on TAC vs. 2.2% of women on FAC during the 8-year follow-up period. Click here to read more.
In 2006, Dr. Scott Sedlacek of the Rocky Mountain Cancer Center presented a study in which 6.3% of breast cancer patients who were given Taxotere, Adriamycin (docorubicin), and Cytoxan (cyclophosphamide) grew back less than 50% of their hair. According to the researchers:
“Such 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.”
In May 2015, Cancer Research published a study in which 10-15% of breast cancer patients who were given Taxotere self-reported permanent hair loss in questionnaires that were sent in October 2013. Of the respondents, 21 (15.8%) had significant scalp hair loss.
In 2012, a study published in the Annals of Oncology investigated 20 women who experienced permanent hair loss after being treated for breast cancer with Taxotere and fluorouracil/epirubicin/cyclophosphamide (FEC).
The researchers wrote that the women had scalp hair loss that resembled male-pattern baldness, and noted “distressing psychological consequences” in the patients’ lives. Treatments including vitamins, Rogaine (minoxidil), psoralen and ultraviolet A therapy, and spironolactone proved to be ineffective.
Does Taxotere Always Cause Hair Loss?
No. In clinical trials, hair loss occurred in 76% of patients with various types of cancer who were given only Taxotere at 100 mg/m2. Studies by Sanofi-Aventis estimate that 3% of patients experience permanent hair loss. However, the risk may be higher when Taxotere is combined with other chemotherapy drugs or administered at higher doses.
Can Rogaine Cure Taxotere Hair Loss?
No. Rogaine (minoxidil) does not cure chemotherapy hair loss from Taxotere, and neither do vitamins, spironolactone, or psoralen and ultraviolet A therapy, according to a study of 20 women published in 2012.
Has the FDA Issued Warnings About Taxotere Marketing?
Yes. In 2009, the FDA issued a Warning Letter (PDF) for three advertisements promoting Taxotere for breast cancer and lung cancer. According to the FDA:
“[Taxotere ads] misleadingly overstate the survival benefits of Taxotere and imply that survival depends on treatment with Taxotere, while also minimizing the serious and potentially life-threatening risks associated with the drug by omitting some risk information and presenting other risk information in an inconspicuous manner.”
In 2002, the FDA also issued a Warning Letter (PDF) to Aventis Pharmaceuticals for “false and misleading” marketing materials that promoted Taxotere for non-small cell lung cancer.
Did Sanofi-Aventis Fail to Warn About Hair Loss?
Taxotere labels in Europe and Canada were updated to include permanent hair loss in 2005 and 2012, respectively. Lawsuits now accuse the drug-maker of failing to provide adequate warnings in the United States until December 2015.
How Many Taxotere Lawsuits Have Been Filed?
As of January 17, 2017, there were a total of 705 Taxotere lawsuits pending in a centralized litigation in Louisiana. The size of this “mass-action” has grown rapidly since it was coordinated in October 2016.
One of the first lawsuits (PDF) was filed in January 2016 by a woman from Ohio who was diagnosed with permanent hair loss after undergoing breast cancer treatment with 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 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.”
Why Are Taxotere Lawsuits Being Filed?
Lawyers say Sanofi-Aventis knew or should have known about the risk of permanent hair loss, but failed to provide adequate warnings. They say patients may have chosen alternative chemotherapy drugs that do not cause permanent hair loss if they had been warned about the risk.
Has Taxotere Been Recalled as a Result of Permanent Hair Loss?
No. The FDA admits that Taxotere is associated with case reports of permanent alopecia, but a recall has not been issued. There could potentially be a recall in the future, but for now the FDA has simply updated warning labels.
In April 2016, Sanofi issued a recall for Taxotere in the United Kingdom (U.K.) because Ethanol may have evaporated from a small number of vials and increased the concentration of Taxotere in the solution. The estimated incidence is about 0.09% for the 4 ml presentation.
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