What is Taxotere?
Taxotere, known generically as docetaxel, is a chemotherapy drug approved to treat breast cancer. It is also approved to treat non-small cell lung cancer, advanced stomach cancer, head and neck cancer, and metastatic prostate cancer, and is being investigated as a treatment for other cancers including small cell lung cancer, ovarian cancer, bladder cancer and pancreatic cancer, soft tissue sarcoma, and melanoma.
Taxotere is manufactured by Sanofi-Aventis, and is in a class of drugs called taxanes. Taxotere chemotherapy is administered intravenously through a vein. The dosage given depends on each patient’s height and weight, her general health, and the type of cancer or condition being treated. Typically, the higher the dosage, the more severe the Taxotere side effects.
Sanofi-Aventis promoted the efficacy of Taxotere in treating cancer, but the company failed to inform the Food and Drug Administration (FDA), health care providers, and patients that clinical trials showed that permanent hair loss – called alopecia – was observed in a number of the patients taking Taxotere.
Taxotere Side Effects
The most common Taxotere side effects include low white blood cell counts, which can increase the risk for infection, and low red blood cell counts, or anemia. Other side effects include:
- Fluid retention with weight gain, swelling of the ankles or abdominal area
- Peripheral neuropathy, causing numbness in the fingers and toes
- Mouth sores
- Hair loss, which may be permanent
Taxotere Hair Loss
Hair loss during chemotherapy is not uncommon and in many cases it is expected. Hair growth returns after treatment. But patients treated with Taxotere were not warned they might never regrow their hair even after stopping treatment. This reported hair loss affects all body hair, including eyebrows, eyelashes, and pubic hair.
Misleading the Public
But in 2009, the Food and Drug Administration (FDA) slapped Sanofi-Aventis with a warning letter when it found that the company was misleading the public by suggesting that Taxotere was safer or more effective than another cancer treatment, paclitaxel.
“FDA is not aware of substantial evidence or substantial clinical experience to support the claims made in the carrier regarding Taxotere’s level of efficacy or superiority to paclitaxel,” the warning letter stated. Sanofi-Aventis also didn’t warn that hair loss with Taxotere could be permanent, only informing users that “hair generally grows back” after completing treatment.
Taxotere and Hair Loss
Sanofi-Aventis knew as early as the 1990s that Taxotere could cause permanent hair loss based on results of its own clinical trial, called GEICAM 9805, which showed 9.2 percent of study participants treated with a combination of drugs including Taxotere suffered persistent hair loss over a 10-year follow-up period. Since then, more studies have shown similar results.
In February 2012, the journal Annals of Oncology published research following 20 women who had been treated with Taxotere, 19 of whom had permanent hair loss, including eyebrows and eyelashes. The researchers concluded, “physicians and patients should be aware of this new distressing side effect.”
In December 2015, the FDA ordered Sanofi-Aventis to change Taxotere’s label to warn patients of permanent hair loss.
Permanent hair loss is a devastating side effect, especially for women, and many have filed lawsuits against Sanofi-Aventis for failing to warn doctors or their patients of the risks with using Taxotere chemotherapy.
In October 2016, 33 Taxotere lawsuits from 25 districts were consolidated into a multidistrict litigation (MDL) in the Eastern District of Louisiana. Since then, the Taxotere MDL has grown to more than 2,000 cases. The first four bellwether trials are scheduled for 2019, with the first expected to begin in January.
Permanent hair loss is an extremely debilitating condition. Attorneys with Beasley Allen Law Firm are currently investigating cases of permanent hair loss in women who have been treated with Taxotere. Fill out the contact form on this page for a free consultation and to see if you may be entitled to compensation.