Side Effects of Taxotere Chemotherapy

Survivors Say Taxotere Causes Permanent Alopecia

A decade of medical research suggests the same thing. But in a series of breaking lawsuits, breast cancer survivors claim they were never warned of the devastating side effect. Between 6% and 15% of Taxotere patients may develop permanent hair loss, and you could be entitled to financial compensation.

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Like most chemotherapy drugs, Taxotere can cause any number of adverse side effects, some of which can be just as debilitating as the effects of cancer itself. Chemicals designed to treat cancer cells are relatively non-specific in their effects. While we look to these agents primarily for their ability to kill cancer cells, most actually kill all active cells, cells capable of dividing and growing.

Thus most of chemotherapy’s side effects occur because the chemicals involved are damaging healthy cells, along with those that have mutated to divide uncontrollably, which we commonly term “cancerous.” On this count, Taxotere is no different.

Common Side Effects Of Taxotere

Taxotere is most commonly used as an adjuvant therapy, in combination with other chemotherapy agents, to kill off breast cancer cells that remain after surgery. The drug has also been approved to treat advanced-stage or metastatic breast cancers, as well as lung, prostate and stomach cancers.

Most chemotherapy drugs, including Taxotere (active ingredient: docetaxel), can cause the following side effects:

• Fatigue, or excessive exhaustion
• Pain, including headaches, pain in muscles and pain in the stomach. Nerve damage, a condition known as neuropathy and discussed in more detail below, can also occur.
• Nausea and vomiting. Nausea and vomiting is so common in chemotherapy patients that chemo drugs are classified in part by how likely a patient is to experience the symptoms. Female patients are generally considered more likely to experience nausea and vomiting after receiving a chemo agent.
• Mucositis. Where healthy cells are concerned, chemotherapy treatments tend to damage cells that divide very quickly, including the epithelial cells lining a patient’s gastrointestinal tract. Mucositis is what happens when these cells break down, leaving the mucous membranes lining a patient’s mouth and throat vulnerable to sores, ulcers and infection.

Often painful, mucositis may also make it more difficult to eat, leading to nutritional imbalances. Mucositis has been implicated as a potential cause of dysgeusia, a complete loss of taste sensation often reported by chemotherapy patients. In breaking down epithelial cells that line the intestines, chemotherapy agents like docetaxel may also cause diarrhea.

• Anorexia. Most chemotherapy patients, more than 50% according to the University of Pennsylvania, experience some level of food aversion or loss of appetite. Mucositis and nausea are likely causes of these chemo-related side effects, collectively referred to as anorexia. Over time, chemotherapy-induced anorexia can result in unintended weight loss and malnutrition.
• Erythema, a condition characterized by a painful redness in the skin of the hands and feet. Erythema may be accompanied by blistering, but it need not be. Desquamation, in which the skin peels off, often follows. Researchers aren’t sure why chemo drugs can cause erythema, although some studies suggest that skin on the hands and soles of the feet absorbs chemotherapy agents more readily, leading to direct toxicity.

Nail disorders have also been linked to many chemotherapy drugs, including Taxotere. Hypo or hyperpigmentation, changes in nail color have been reported, as have cases of onycholysis, in which the nail separates from the nail bed completely.

• Fluid retention, when liquids build up in the body, which can cause “edema,” or swelling. In Taxotere patients, edema usually begins in the lower limbs, but can become generalized.
• Hypersensitivity reactions, or allergic reactions, marked by generalized rashes, low blood pressure and difficulty breathing. Cases of fatal anaphylaxis, allergic reactions that result in shock, have been reported in patients taking Taxotere. Prior to being infused with the drug, patients should be given an oral corticosteroid, which reduces inflammation.

Blood-Related Side Effects

Chemotherapy treatments like Taxotere inhibit the ability of cancer cells to reproduce, but they also prevent healthy cells from dividing. This undesirable, though currently inevitable, side effect is perhaps most pronounced in the case of cells in the bone marrow, which produce new blood cells. Without a fully-functioning production system, many chemotherapy patients experience a cluster of blood disorders, all caused by decreased levels of white, red or colorless blood cells:

• Thrombocytopenia, a condition marked by low levels of blood platelets. Platelets are uncolored blood cells that gather around sites of injury to promote clotting. People with thrombocytopenia may bruise easily, bleed for longer than normal, suffer from excessive fatigue or experience abnormally heavy menstruation. Internal bleeding is possible, but usually occurs only in patients with severely low platelet counts.
• Neutropenia, a low blood concentration of neutrophils, a type of white blood cell. Neutrophils are the body’s main defense against infection. Neutropenia is observed in almost all patients receiving Taxotere.
• Leukopenia is a reduction in white blood cells generally. Although low levels of circulating neutrophils are common in leukopenia, other types of white blood cells, like lymphocytes and basophils, may also be deficient.
• Anemia, a decrease in either red blood cells themselves or hemoglobin, a molecule that brings oxygen from the lungs to body tissues. In cases of anemia, a patient’s organs and body tissues can be “starved” of oxygen, leading to fatigue, shortness of breath and wooziness.

Low white and red blood cell counts are very common in Taxotere patients, affecting more than 30% of patients, according to http://chemocare.com. Neutropenia and leukopenia specifically put many chemo patients at an increased risk for developing infection.

Eye Disorders

Cystoid Macular Edema, or CME, is a condition in which small pockets of fluid, which closely resemble cysts, build up in the eye’s retina. Most commonly, CME results in blurry or impaired vision. According to Taxotere’s labeling information, cases of CME have been reported among patients taking docetaxel. Physicians are asked to discontinue treatment if symptoms of CME arise.

Nervous System Disturbances

Prepared for intravenous administration, Taxotere contains ethanol, more commonly known as alcohol, which can cause central nervous system disturbances in some patients.

Before 2014, the drug’s warning label carried no mention of this risk. But on June 20, 2014, the US Food & Drug Administration revised the labeling for every docetaxel product, informing patients and physicians that the chemical’s alcohol content “may cause patients to experience intoxication or feel drunk during and after treatment.” Patients should not drive, or take part in other activities that may be dangerous, for “one to two hours” after receiving an infusion of docetaxel.”

Peripheral neuropathy, a collection of symptoms caused by nerve damage in the arms and legs, can also occur. Since these nerves lie far away from the brain and spinal cord, they are often classified as part of the “peripheral” nervous system. While chemotherapy-induced peripheral neuropathy, or CIPN, is fairly common, it can be disabling for patients. Nerves are responsible for a host of sensations and physical capabilities. Thus damage to nerves can result in a wide range of symptoms:

• Pain, either intermittent or chronic
• Tingling, burning or numbness
• Difficulty using fingers
• Impairment of reflexes
• Increased sensitivity to temperature or pressure
• Asthenia, an abnormal weakness. In clinical trails, almost 15% of metastatic breast cancer patients taking Taxotere experienced severe asthenia.
• Constipation or incontinence (the peripheral nervous system is instrumental in controlling bowel and bladder function)
• Trouble maintaining balance
• Stumbling or tripping over objects, and the resultant risk of sustaining a serious fall
• Alterations in blood pressure

Severe instances of CIPN can go beyond pain and coordination issues, affecting heart rhythms and blood pressure. Organ failure and paralysis are rare, albeit devastating, risks.

Toxic Deaths

In clinical trials, docetaxel has been “associated with deaths considered possibly or probably related to treatment,” according to Taxotere’s FDA approved warning label. These deaths have been tentatively linked to liver function. In patients being treated for metastatic breast cancer, death occurred in 2% of patients with normal liver function. Among patients with abnormal liver function, 11.5% of patients died.

Again, most chemotherapy treatments come with serious side effects, complications that many patients, not a small sub-set, will experience. But in treating cancer, a disease almost universally fatal if left untreated, risk and benefit decisions are highly complex, and many patients are willing to overlook severe side effects in the search for a treatment that will stop their cancer from spreading.

Pharmaceutical manufacturers, however, aren’t allowed to make those risk-benefit decisions for patients. In marketing their products, drug companies must publicize every known risk, so physicians and patients are able to make their own well-informed treatment decisions. That’s not just ethical common sense; it’s federal law.

Taxotere & Hair Loss

In a series of recent lawsuits, patients say Taxotere’s manufacturer, a French company called Sanofi, actively concealed its knowledge of one major risk: permanent hair loss.

Hair loss, or alopecia, is common during regimens of chemotherapy, as chemo agents attack healthy cells that divide rapidly. Hair follicles, according to BreastCancer.org, “are some of the fastest-growing cells in the body.”

While the rate and extent of hair loss varies widely based on which chemo drugs are being used, most patients will have lost some or all of their hair within a few weeks of beginning treatment. Hair loss can be slow or abrupt, incomplete or complete. Patients taking Taxotere frequently report hair loss that resembles male pattern baldness.

Despite being common, and perhaps the most recognizable side effect of chemotherapy, hair loss can be extremely depressing for patients. Hair, especially for female patients, carries great cultural and personal significance. Many women consider their hair a fundamental aspect of their identity, and its loss can initiate a period of grieving, anxiety and social withdrawal. Some breast cancer survivors, including the women interviewed for Dr. T.G. Freedman’s 1994 study, say losing their hair was more difficult psychologically than losing a breast.

Differences Between US, European Labeling Raise Questions

Luckily, alopecia is usually temporary, with hair slowly returning to its normal growth rate after treatment has ended. When Taxotere was first approved, in 1999, the drug’s warning label suggested as much:

“Loss of hair occurs in most patients taking Taxotere (including the hair on your head, underarm hair, pubic hair, eyebrows, and eyelashes). Hair loss will begin after the first few treatments and varies from patient to patient. Once you have completed all your treatments, hair generally grows back.”

In the European Union, however, Taxotere’s labeling bore a very different warning, mentioning “non-reversible” and “persisting” cases of alopecia on multiple occasions. The drug’s European label began listing reports of permanent alopecia, hair loss lasting as long as 10 years and 5 months after the end of treatment, at least as early as 2005.

But in the US, Taxotere’s label actually became less specific over time. In 2010, any mention of how long hair loss would persist was mysteriously removed from the chemical’s US labeling, including the statement that “once you have completed all your treatments, hair generally grows back.” Instead, the 2010 label mentioned only “hair loss” under the drug’s “most common adverse reactions,” with no details on how long hair loss generally lasted.

It was only in 2015, at the urging of the US Food & Drug Administration, that Sanofi added a reference to “cases of persisting alopecia” to Taxotere’s US warning label. Recent research, beginning in 2006, has shown that the drug’s risk of lifelong hair loss may be far higher than was once believed. Today, women have begun to step forward, claiming Sanofi failed to warn them of this potentially devastating side effect.