Update: Court Overseeing Taxotere MDL Convenes “Science Day”
March 31, 2017 – The court overseeing the Taxotere litigation in the Eastern District of Louisiana will hold a “Science Day” on May 3 to discuss medical and scientific issues related to the litigation. The event is intended to provide a sort of tutorial so that the court can learn more about the case and the science involved. Cross-examination is forbidden, and transcripts of the proceedings are not shared with the parties.
Taxotere (generic: docetaxel) is a chemotherapy medication used to treat several types of cancer. The drug is most often prescribed for the primary treatment of breast cancer; however, it may also be used as part of a combination regimen to treat secondary breast cancer, non-small cell lung cancer, head and neck cancer, stomach cancer and prostate cancer.
Taxotere is classified as a cytotoxic medication, which means that it is damaging and toxic to cells. Although the drug is used to kill cancerous cells, it can also kill off healthy cells in the body. Taxotere is made by Sanofi SA, and was approved by the U.S. Food & Drug Administration (FDA) in 1996.
What’s the Problem?
Taxotere has recently been linked to permanent hair loss, also known as permanent significant alopecia or PSA. Temporary hair loss is a common side effect of chemotherapy treatment, but permanent alopecia is not. Lawsuits on behalf of breast cancer survivors are now being filed against Sanofi-Aventis, alleging that the company failed to adequately warn the public and medical communities about the risk of permanent baldness with Taxotere.
Taxotere Side Effects
The most serious and devastating side effect associated with Taxotere is permanent hair loss or alopecia. Other side effects linked to the drug include:
- Bone, muscle or joint pain
- Fatigue and weakness
- Fluid retention with weight gain
- Swelling of the ankles or abdominal area
- Low red blood cell count (anemia)
- Low white blood cell count
- Mouth or throat sores
- Nail changes (color changes to your fingernails or toenails)
- Peripheral neuropathy (numbness in your fingers and toes)
- Taste changes
Taxotere Hair Loss Studies
There are currently about 2.8 million women living in the U.S. who have a history of breast cancer, according to breastcancer.org. Of these, approximately 75% underwent chemotherapy treatment with Taxotere. The following studies have identified links between the use of Taxotere and the development of permanent hair loss:
- A February 2012 study published in the Annals of Oncology found that Taxotere is associated with an increased risk of permanent alopecia. Researchers looked at 20 female breast cancer patients who took docetaxel (the active ingredient in Taxotere) for chemotherapy and subsequently developed permanent hair loss. Mineral deficiencies and thyroid disorders were ruled out as contributing factors, and all but one of the test subjects had no history of alopecia.
- At the 2014 NCRI National Cancer Conference, researchers presented evidence indicating that permanent hair was a side effect in 10-15% of cancer patients treated with Taxotere. “Long term significant scalp alopecia (here lasting for up to 3.5 years following completion of chemotherapy) may affect 10-15% of patients following docetaxel for EBC [early breast cancer],” the researchers said. “This appears to be unrelated to other patient and treatment characteristics. ”
- A 2008 study published in the New England Journal of Medicine (NEJM) found no significant difference in survival rates between cancer patients treated with Taxotere and those taking Taxol (generic: pacitxel), another chemotherapy drug that has not been linked to permanent alopecia.
- Sanofi’s own internal studies indicate that up to 10% of patients treated with Taxotere would suffer permanent hair loss.
What is Alopecia?
Alopecia is a potential side effect of chemotherapy and radiation therapy, according to the American Society of Clinical Oncology (ASCO). There are several different forms of the condition:
- Alopecia Areata Patchy – The most common variation of the disease, alopecia areata presents as round, smooth patches of various sizes.
- Alopecia Areata Totalis – Presents as total hair loss on the scalp.
- Alopecia Areata Universalis – The rarest form of alopecia, which presents as the loss of hair over the entire scalp and body.
Managing Hair Loss During Chemotherapy
Management of hair loss during chemo focuses on the patient’s comfort, safety and protection from the sun. According to the Cleveland Clinic, the following options are available for coping with hair loss during cancer treatment:
- Short hair – You may want to cut your hair short if you are experiencing alopecia during chemotherapy. Since hair often does not fall out evenly, some patients find that losing short hair is less distressing or embarrassing. Other patients may wish to shave their hair completely off until treatment is complete.
- Wigs – If you are interested in wearing a wig during chemo, you may want to purchase it before you lose any hair. This way you can find the best match for your natural hair style and color. Many insurance companies will pay for a wig, and there are hair stylists who specialize in wigs for alopecia.
- Caps / Scarves – Some cancer patients find that the easiest, most comfortable option for dealing with hair loss are caps and scarves. A wide range of these products are available exclusively for people undergoing chemotherapy.
- “Look Good, Feel Better” – Program sponsored by the American Cancer Society (ACS) that addresses ways to tie scarves and make yourself look and feel better while experiencing hair loss during and after chemotherapy.
Has Taxotere Been Recalled?
To date, there has not been a recall of Taxotere related to alopecia. However, in December 2015, the FDA did acknowledge that the drug could cause permanent hair loss, and this warning will now be placed on Taxotere labels.
Are Lawsuits Being Settled?
The taxotere litigation is still in its early stages, and no large settlements have been reached over injuries allegedly caused by the drug. However, our lawyers are actively pursuing litigation in the discovery stage, and we are continually uncovering more information about the link between Taxotere and alopecia. Contact us today to learn more about your legal rights.
Is There a Class Action?
No class action lawsuit has been filed in the Taxotere litigation to date. However, patients who experienced permanent alopecia or balding after taking the medication may be able to pursue a settlement through the filing of an individual lawsuit. If our lawyers find that you have a legitimate claim, you may be entitled to compensation to help with medical expenses, lost wages, pain and suffering, and more.
As of July 2016, at least 33 lawsuits have been filed against Sanofi-Aventis alleging that Taxotere causes permanent hair loss or baldness in patients treated with the drug, most often in women undergoing breast cancer treatment. On July 22, attorneys for 2 of the plaintiffs requested that all federal Taxotere lawsuits be consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana. As of this writing, a ruling on that request has not been given.
Taxotere lawsuits allege that Sanofi-Aventis failed to adequately warn doctors and patients about the increased risk of permanent alopecia associated with Taxotere use during chemotherapy. The complaints argue that had the manufacturer properly warned of this risk, patients would have opted to take Taxol, another chemotherapy medication that does not cause permanent hair loss.
Taxotere Alopecia Lawsuits Centralized in Louisiana
October 7, 2016 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered all federal lawsuits alleging permanent hair loss or “alopecia” from Taxotere to be consolidated into a multidistrict litigation (MDL No. 2740) for pretrial handling in the Eastern District of Louisiana. At least 33 federal complaints pending in 16 states accuse Sanofi-Aventis of marketing Taxotere as superior to other chemo treatments, despite having knowledge that it could cause permanent hair loss.
1996 – Taxotere first approved by the U.S. Food & Drug Administration (FDA)
1998 – Approval received as first-line treatment
Drug receives approval as a first-line treatment for metastatic breast cancer in patients whose disease has recurred despite adjuvant therapy.
2001 – Voluntary recall issued
Voluntary recall issued for Taxotere Injection Concentrate 20-mg active and diluent vials. Affected lot numbers included: 0P273 (active), which was packaged together with diluent vials with lot numbers 0T446 and 0T449.
2008 – New England Journal of Medicine study published
Study published in the New England Journal of Medicine (NEJM) finds no significant difference in survival rates between cancer patients treated with Taxotere and those taking Taxol (generic: pacitaxel).
2012 – Annals of Oncology research published
Research published in the Annals of Oncology identifies an association between Taxotere and permanent alopecia. This is the first study to find a link between Taxotere and permanent hair loss.
2014 – Evidence presented at National Cancer Conference
Evidence presented at the National Cancer Conference indicating that 10-15% of cancer patients treated with Taxotere will suffer permanent hair loss. “Long term significant scalp alopecia (here lasting for up to 3.5 years following completion of chemotherapy) may affect 10-15% of patients following docetaxel for EBC [early breast cancer],” the researchers said. “This appears to be unrelated to other patient and treatment characteristics. ”
2015 – Hair loss and baldness reports acknowledged by FDA
FDA acknowledges reports of permanent hair loss and baldness in chemotherapy patients treated with Taxotere. The agency’s announcement preceded a label change for the product, noting the possibility of permanent hair loss.
2016 – Woman files lawsuit against Sanofi SA
A California woman files a lawsuit against Sanofi SA alleging that it knew about an increased risk of permanent hair loss and other serious side effects with Taxotere, but went to great lengths to hide the problem and promote the drug’s alleged superiority. The complaint is: Dodson v. Sanofi SA, et al., case number 3:16-cv-01251.
2016 – United Kingdom’s MHRA issues recall
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issues a recall for one batch of Taxotere over a potential risk that the solution may contain over-concentrated amounts of the drug’s active ingredient, docetaxel.
- “U.S. Breast Cancer Statistics”. Breastcancer.org. May 11, 2016.
- “Permanent scalp alopecia related to breast cancer chemotherapy by sequential fluorouracil/epirubicin/ cyclophosphamide (FEC) and docetaxel: a prospective study of 20 patients”. Annals of Oncology. May 9, 2012.
- ”Long Term Hair Loss in Patients with Early Breast Cancer Receiving Docetaxel Chemotherapy”. 2014 NCRI Cancer Conference. November 2-5, 2014.
- ”Weekly paclitaxel in the adjuvant treatment of breast cancer”. New England Journal of Medicine (NEJM). April 17, 2008.
- ”Hair Loss or Alopecia”. American Society of Clinical Oncology (ASCO). March 2015.
- ”Chemotherapy for Breast Cancer”. Cleveland Clinic. September 23, 2013.
- ”Look Good Feel Better”. Personal Care Products Council Foundation. 2015.
- ”Taxotere (docetaxel) injection concentrate”. U.S. Food & Drug Administration (FDA). December 2015.