Patients who are diagnosed with breast cancer are faced with 6-9 months of treatment in the initial phase after diagnosis, including surgery, radiation, and chemotherapy, followed by hormone therapy. Choices of treatment modalities depend on the particular type of cancer and the stage at which the cancer is caught. Chemotherapy has been one of the standard treatment modalities for breast cancer since the early 1990s, when it was discovered that a molecule isolated from the Yew tree can affect cancer cells in such a way as to effectively combat the disease. The first such chemotherapy agent, known as Taxol, was discovered through research conducted on behalf of the National Cancer Institute, and it created a treatment revolution.
What is Taxotere®
Taxotere® (doxetaxel), manufactured by Sanofi-Aventis, is a second newer and doubly potent chemotherapy drug, that was approved by the FDA in 1996 for treatment of breast cancer. From the outset, Sanofi-Aventis promoted Taxotere® aggresively, suggesting (arguably without evidence) that because it was twice as potent as Taxol, it was also twice as effective, and it quickly captured a large portion of the market.
Taxotere® lost its patent protection in March 2011, and generic versions of the drug have been manufactered since then. In addition to other manufacturers, Taxotere® is still being manufactured by Sanofi-Winthop Industries and Winthrop US, entities that are related to Sanofi-Aventis.
How It is Used
Chemotherapy drugs eliminate cancerous cells by stopping the division of cells, and attacking the RNA or DNA that instructs the cells how to multiply by essentially dividing. If cells cannot divide and increase in number, they simply expire. Classified as a plant alkaloid chemotherapy drug, Taxotere® destroys the cells in different phases of their division, so that they cannot spread and grow. Generally, Taxotere® is used by patients who endured previous sessions of chemotherapy without success and are in advanced stages of the disease, or when the cancer has metastasized.
Like all drugs, Taxotere® causes a host of side effects, including low white blood cell and platelet count, fluid retention, peripheral neuropathy, nausea, diarrhea, vomiting, mouth sores, hair loss (otherwise known as alopecia), lethargy, infections, nail changes, and muscle/bone/joint pain. Patients may require frequent blood tests to ensure that their liver has not sustained excessive damage from the chemotherapy treatments. Like other chemotherapy agents, Taxotere® has always been known to cause temporary hair loss – but hair was expected to grow back in a period of months after the chemotherapy treatment ended. This is something all patients and all doctors know about – indeed, even non-patients know that chemotherapy agents caused temporary hair loss.
Drug Hazards: Permanent Hair Loss
But for a woman, temporary hair loss is nothing like permanent hair loss.
In 2009, a warning about permanent hair loss after treatment was added to labels in Europe and in 2011, a warning about permannet hair loss after treatment was added to labels in Canada. But not the United States.
In 2012, a report published in the Annals of Oncology concluded that severe and permanent hair loss was a side effect of the sequential FEC-docetaxel regimen that was being used for early breast cancer adjuvant treatment.
In 2014, a National Cancer Conference presentation concluded that 15% of women using Taxotere® would be expected to experience permanent hair loss.
Sanofi-Aventis’ own internal studies – dating back to the 1990s – show that the company was aware that up to 10% of patients would be affected.
Despite these studies, Sanofi-Aventis downplays the risk and fails to transparently disclose the statistics available to them, stating that they are unable to disclose how many Taxotere® patients were affected by permanent alopecia and implying that it was a very rare phenomenon.
On December 11, 2015, the FDA ordered Sanofi-Aventis to update its label to include the risk of permanent alopecia. Under the approved new language, the last line in a sub-section called Cutaneous in the Post-Marketing Experiences section of the label reads, “Cases of permanent alopecia have been reported.” In the section on common side effects in the Patient Information booklet, there is a sentence that reads, “hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”
Filing a Taxotere® Lawsuit
Current litigation alleges that the manufacturer Sanofi-Aventis knew about the permanent alopecia risk for cancer patients who used Taxotere®, and failed to warn patients and physicians. Moreover, the manufacturer promoted the drug as superior to other chemotherapy drugs when, in fact, they are equivalent medications, and that the alternatives do not contain the added risk of permanent hair loss.
Permanent baldness may rob you of your confidence and self-esteem, making socializing and even working a challenge due to the level of psychological distress you may experience. If you are a breast cancer survivor who sustained permanent alopecia after taking Taxotere® for your chemotherapy treatment, you may be eligible to file a claim.
Dangerous Drug Lawyers at Williams Cedar Will File a Taxotere® Lawsuit to Recover Compensation on Your Behalf
Our dangerous drug lawyers at Williams Cedar will support you after suffering from injuries due to Taxotere®. We will hold the manufacturers who failed their consumers responsible. Call us today at 215-557-0099 or contact us online to schedule a consultation with a skilled member of our legal team. Our offices are located in Philadelphia and Cherry Hill, New Jersey, and we serve clients throughout the country.