Taxotere is a chemotherapy drug used in the treatment of various types of cancer. It is linked to many serious side effects, including five potentially life-threatening conditions contained in a black box warning on the drug’s label. Also, Taxotere has been found to result in permanent hair loss.
Chemotherapy drugs such as Taxotere are very strong cancer treatments used to target and kill cancer cells. Because of the amount of toxins pumped into the body during the course of treatment, the drugs are often associated with several side effects, including the most commonly recognized side effect of hair loss. Other side effects can be serious and even life-threatening.
Drug labeling for Taxotere contains a boxed warning, also called a black box warning (a very serious type of warning), that includes five different serious side effects and complications associated with use of the chemotherapy drug. In addition to those black box warnings, Taxotere has been linked to a long list of other serious side effects as well, ranging from skin reactions and impaired eyesight to leukemia and fetal harm and/or death.
Taxotere has also been linked to permanent hair loss affecting patients’ scalps and body hair, including eyebrows and eyelashes. The hair loss is distressing to patients who may survive their cancer diagnosis but will have to learn to cope without hair. The hair on the head and body often does not grow back, even months to years after treatment with Taxotere has ended.
Several postmarketing studies have linked Taxotere to hair loss, also called alopecia. While hair loss is usually a common side effect associated with most cancer treatments, the patient typically does not experience a complete loss of hair and the hair that is lost generally regrows after a period of time following chemotherapy. But with Taxotere, complete hair loss has been shown to be permanent. One study found that the drug’s adverse effect was irreversible in 95 percent (19 out of 20) of the women observed.
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Alopecia can be characterized by round patches of hair loss (alopecia areata), which can lead to total hair loss in some instances (about 7 to 25 percent of cases), or complete hair loss on the scalp and body (alopecia universalis or alopecia totalis), also referred to as the advanced form of alopecia areata. Taxotere is most commonly linked to alopecia universalis (AU), which can also result in the loss of one’s eyebrows and eyelashes.
The exact cause of alopecia universalis is unknown. But it is believed to be an autoimmune reaction in which a person’s immune system mistakenly attacks the hair follicles. The condition’s onset may be a combination of environmental factors, such as the use of Taxotere, as well as genetic influence. This also means that just because a person has a genetic predisposition to develop AU, it may not ever occur without an environmental trigger to set it off. With patients receiving chemotherapy, the drug can result in harm to the cells that make hair, thereby causing the patient’s hair to fall out. This hair loss may occur just two to three weeks after starting chemotherapy.
Environmental factors, other than Taxotere, that may trigger the development of AU include:
AU can affect men, women and even children. There is no cure for AU, and while hair regrowth may occur on its own, even after many years, only about 10 percent of individuals affected by AU (without the use of Taxotere) will experience a full recovery.
Alopecia universalis (AU) is characterized by the complete loss of hair, including hair on both the head and body. Therefore, hair loss is usually the only symptom experienced by the patient. However, some patients affected by AU may also experience a burning or itching sensation.
In some cases, AU can also be associated with other conditions including:
Anxiety, personality disorders, depression and paranoid disorders are also more common in patients with different forms of alopecia areata.
Total hair loss seen in patients with AU can occur within six months after the onset of symptoms.
There is no one treatment that has been found to be most effective in treating patients with alopecia universalis (AU), and there is currently no cure for the condition. Managing AU can therefore present a challenge to doctors and patients alike.
Injectable steroids, medicines applied to the skin and ultraviolet light therapies are the most common treatments used for hair loss. Wigs may be used to hide the physical aspect of hair loss.
Although several treatments, including those mentioned above, have been proposed, no therapy is currently approved by the U.S. Food and Drug Administration (FDA) to treat AU.
Some therapies being explored include:
One class of drugs called JAK inhibitors, including Tofacitinib and Ruxolitinib, has been shown in several studies to be effective in treating alopecia areata and AU. But these medications have not yet been FDA-approved for use in skin conditions.
In small studies, other treatments have been reported to sometimes be effective in treating alopecia areata, but overall results vary.
These treatments include:
There is also an emotional aspect to hair loss in patients with alopecia universalis (AU), especially in those who also have cancer. Although the loss of hair by itself is not life-threatening, it can significantly impact a patient’s quality of life. Support for patients undergoing chemotherapy is especially important.
Some steps that can be taken to ease the discomforts associated with the loss of hair include:
Cold caps are tightly fitting hats filled with gel that’s chilled. The cap is strapped onto the head before, during and after chemotherapy and may help some patients to keep some of their hair.
The cold temperature of the caps causes the blood vessels beneath the skin in the scalp to narrow, thereby reducing the amount of drug exposure to the hair follicles. In theory, the less chemotherapy drug contaminating the hair root, the less likely the hair is to fall out.
While some doctors are concerned about the effectiveness of chemotherapy medicines in being able to reach and kill cancer cells in the scalp in patients wearing these tight caps, several European studies, including a 2013 German study, have found that the cooling cap does not increase a patient’s risk of metastasis in the scalp.
Taxotere is also associated with several other serious, potentially fatal, side effects and complications of treatment. The drug label contains a handful of black box warnings in addition to warnings related to the possibility of other serious side effects.
Serious side effects of Taxotere include:
Taxotere is also found to contain alcohol, which may affect a patient’s central nervous system. Taxotere used during pregnancy can cause serious injury and death to the fetus.
The label advises that treatment-related deaths increase with abnormal liver function, at higher doses, and in patients with non-small cell lung cancer (NSCLC) and prior platinum-based therapy (a specific class of cytotoxic chemotherapy drugs derived from the element platinum) in recipients receiving Taxotere at 100 mg/m2.
Certain medications, such as Taxotere, when taken in overdoses or sometimes when taken within therapeutic dosing ranges, can injure the liver. Chemical damage to the liver is called hepatotoxicity. Taxotere’s label advises that administering the drug to patients with elevated LFT (or liver function test) levels can increase the risk of severe or life-threatening complications; and further, that LFTs should be obtained before each treatment cycle.
The liver is primarily responsible for filtering wastes and toxic substances from the body. Chemotherapy drugs, such as Taxotere, can cause the organ to function less efficiently due to the added stress on the organ to filter the extra toxins. When these toxins accumulate in the body faster than the liver can eliminate them, liver damage can occur.
Symptoms of liver damage may include:
Liver damage cannot be cured or reversed once it occurs. However, certain medications, such as diuretics to reduce fluid accumulation and swelling, along with lifestyle changes, may assist in easing symptoms associated with the condition.
An abnormally low concentration of neutrophils (a type of white blood cell) in the blood characterizes this condition, causing patients to become more susceptible to bacterial infections that, without immediate medical treatment, can become fatal. The label advises that Taxotere should not be administered in patients with neutrophil counts under 1500 cells per 3 cubic millimeters (mm3) of blood volume. Physicians should obtain frequent blood counts to monitor for this condition in patients being treated with Taxotere.
Signs and symptoms of neutropenia may include:
Treatments for neutropenia and its symptoms often result in their own side effects as well, such as bone pain, headache, joint pain, weakening of the bones, inflammation of the blood vessels, an enlarged spleen, kidney disease and rashes.
A low white blood cell count resulting from Taxotere use can cause additional complications for cancer patients in their treatment options and outlook.
Not only is the development of neutropenia during chemotherapy possibly life-threatening, but it can result in a decision to reduce the intensity of cancer treatment. This can put a patient’s outlook for recovery and survival at risk.
Patient factors that might influence the development of drug-induced neutropenia include age, other existing health conditions and serum albumin (protein) levels.
Patients treated with Taxotere are especially at risk of experiencing hypersensitivity reactions during the first and second infusions. A reaction can occur within a few minutes after receiving a Taxotere infusion.
These reactions may include:
Severe hypersensitivity has been reported even in patients premedicated with three days of corticosteroids (dexamethasone), according to the drug’s label. Patients who have severe reactions should immediately stop taking the drug and seek immediate medical attention.
Anaphylaxis can affect several organs, systems and parts of the body, resulting in symptoms that can develop quickly, usually within seconds or minutes.
These symptoms may include:
This condition may occur despite dexamethasone (used to treat inflammatory conditions) and may be severe, according to Taxotere’s drug label.
When fluid retention occurs, it usually begins in the lower extremities of the body (peripheral edema), including the feet and ankles. As the condition progresses, the accumulation of fluid may become generalized throughout the body with an average weight gain of about 4 to 5 pounds.
Common treatments for fluid retention include the use of oral diuretics and restricting a patient’s salt intake.
In 92 breast cancer patients using corticosteroids, 6.5 percent experienced severe fluid retention. Nine of the 92 patients (9.8 percent) had to discontinue treatment with Taxotere due to the fluid retention. The condition was sometimes slowly reversible in such patients, taking about 16 weeks from the last infusion with Taxotere to completely resolve.
Please seek the advice of a medical professional before making health care decisions.
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.
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