Taxotere (docetaxel) is an antineoplastic agent used as chemotherapy to treat a number of types of cancer. It is used in combination with other drugs such as cisplatin, fluorouracil, doxorubicin, cyclophosphamide and prednisone and is approved to treat:
- Breast cancer
- Non-small cell lung cancer
- Prostate cancer
- Gastric adenocarcinoma
- Head and neck cancer
Taxotere Side Effects
All medications carry side effect warnings. In most cases, drug side effects are mild to moderate and may go away with time. Taxotere is a medication used for chemotherapy treatment of cancer which are serious medical conditions. Most of the side effects of Taxotere may be more severe than those of other medications.
The common side effects of Taxotere may include:
- Difficulty breathing
- Constipation or diarrhea
- Nausea and vomiting
- Inflammation of the skin
- Inflammation of mucous membranes
- Muscle pain
- Loss of appetite
- Fluid retention
- Unusual or loss of sensations
- Hair loss
Some of the side effects of Taxotere may be treatable or reduced in severity with administration of other medications. Other side effects of Taxotere may be more severe or serious and result in permanent injury. The benefits of any chemotherapy treatment must be weighed against the risks which may include serious adverse events, some of which are life-threatening.
Serious adverse events caused by Taxotere may include:
- Liver impairment
- Hematologic effects
- Skin reactions
- Neurologic damage
- Eye disorders
Like many chemotherapy drugs, Taxotere carries serious “black box warnings” about side effects that may be caused by the medication. A black box warning is the most severe warning that can be issued by the U.S. Food and Drug Administration (FDA) and is required to be printed in a box enclosed by a thick, black border at the top of all prescribing information. Taxotere’s black box warning states that it may result in:
- Toxic death
- Liver toxicity
- Hypersensitivity reactions
- Dangerously low white blood cell counts
- Severe fluid retention
These side effects may increase the chance for treatment-related death, not related to the underlying cancer. Patients who receive higher doses, have abnormal liver function or who have been treated previously with a platinum-based chemotherapy drug may be more likely to experience these severe reactions which may be fatal.
Taxotere and Hair Loss
Hair loss is an unfortunate side effect of many chemotherapy drugs and cancer treatment. In most cases, hair that is lost during treatment for cancer will grow back within 3 to 6 months after the treatment is discontinued.
Patients who took Taxotere for treatment of breast cancer or other cancers were warned of temporary hair loss. Contrary to warnings however, between six and nine percent of patients who experienced hair loss during Taxotere treatment did not have hair growth return. These patients have permanent alopecia and may have experienced negative consequences due to that hair loss.
Patients who lose hair during chemotherapy often face psychological challenges, even when that hair loss is temporary. When hair loss has become permanent, patients may experience:
- Low self-esteem
- Poor body image
- Difficulty transitioning back to everyday life
- Loss of identity
Despite undergoing treatments to stimulate new hair growth, many patients only see a slight improvement and up to 7 in 10 may ultimately choose to wear a wig or scarf to hide their permanent alopecia.
Taxotere False Marketing
In 1998, a research study known as GEICAM 9805, funded by Sanofi, showed a potential for permanent hair loss associated with Taxotere use. The GEICAM study compared Taxotere against another chemo drug, fluorouracil, both used in combination with doxorubicin and cyclophosphamide.
Patients who were given Taxotere experienced greater success in treatment of their cancer but noted a greater amount of hair loss and other side effects. It was determined that the Taxotere combination may result in severe hair loss in 9.2% of patients. Despite this knowledge of potentially greater side effects including permanent baldness, Sanofi chose to market the medication as safer and more effective and pushed for more use in a greater variety of cancers.
Taxotere’s warning about alopecia or permanent baldness was not acknowledged by Sanofi until 2015, even though the company had known about the potential risk for many years.
Taxotere Lawsuits and Settlements
Drug maker Sanofi-Aventis is facing lawsuits filed by users of Taxotere for severe side effects like irreversible, permanent hair loss. Chemotherapy patients may have expected temporary hair loss but found that their hair did not grow back.
Federal Taxotere hair loss lawsuits have been consolidated into multidistrict litigation (MDL 2740) in U.S. District Court for the Eastern District of Louisiana. The MDL lawsuit may include 10,000 or more cases but other lawsuits may have been filed in local and state courts as well.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.