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).
Need a Texas Taxotere Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with permanent baldness, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Frequently Asked Questions
Taxotere and Hair Loss
Why does Taxotere make your hair fall out?
What can I expect during treatment?
Does Taxotere cause permanent hair loss?
What studies have linked Taxotere and permanent baldness?
Does Taxotere Always Cause Hair Loss?
Have Taxotere lawsuits been filed?
Has the FDA issued warnings about Taxotere marketing?
Did Sanofi-Aventis fail to warn about hair loss?
Why are Taxotere lawsuits being filed?
Has Taxotere been recalled?
What damages could I receive?
Is there a Taxotere class action lawsuit?
How long do I have to file a Taxotere lawsuit?
How long will my Taxotere lawsuit take?
How much will this cost?
Will I have to go to trial?
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.
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.
- 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.
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
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.
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 hair loss is not.
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.
In December 2015, the FDA updated the label on Taxotere to include permanent alopecia. Before the updates, the label reassured women that “hair generally grows back.”
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.”
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.
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.
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.
Yes. 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.”
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.
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.
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.
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.
- Medical expenses
- Permanent injuries
- Loss of income or decreased earning ability
- Physical and emotional pain and suffering
- And more
There are no class action lawsuits against Taxotere for hair loss victims, and it is unlikely that this litigation will be resolved in a class action. Instead, individual lawsuits are being filed by victims who have hired their own lawyer.
In October 2016, judges centralized 89 federal Taxotere lawsuits involving permanent hair loss in a Multi-District Litigation (MDL No. 2740) in the U.S. District Court for the Eastern District of Louisiana under Judge Lance M. Africk.
Every state has a “statute of limitations” on when a lawsuit can be filed. It ranges from one year to several years after the date of an injury. After this time-limit has expired, it is much more difficult for an injured person to seek compensation. This is why it is essential to contact a lawyer as soon as you think you have a case.
Every case is unique and it is difficult to determine how long it will take to resolve. Some cases settle in a matter of months, while others take years to go through settlement negotiations or a jury trial.
The Clark Firm, LLP handles personal injury claims on contingency-fee, which means that our fee is a percentage of the recovery we obtain for you.
Most of the personal injury cases handled by our law firm are settled out of court. However, there are occasions when it is in the plaintiff’s interests to take the case to trial.
Need a Taxotere Lawyer in Texas?
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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Taxotere lawyers for a free lawsuit review.