Taxotere (docetaxel) is an intravenous chemotherapy drug that is part of a drug class known as taxanes. These are diterpenes produced by Taxus plants that have a taxadiene core. Taxotere was originally manufactured by the New Jersey pharmaceutical company Aventis, which is now called Sanofi-Aventis after a 2004 merger with Sanofi-Synthélabo. Taxotere was developed from the bark of the Pacific Yew tree. It was originally approved by the U.S. Food and Drug Administration (FDA) in 1996 after its clinical trials showed that the drug increased survival compared to other drugs. The drug was approved for locally advanced or metastatic breast cancer.
Breast cancer is one of the most common types of cancer and affects about 300,000 women annually. Before 2009, most breast cancer patients were being treated with Taxotere, making it the most prescribed chemotherapy drug in the U.S. at that time. Taxotere has also been used off-label for non-small cell lung cancer, gastric adenocarcinoma, hormone-refractory prostate cancer, and head and neck squamouscell carcinoma.
How Does Taxotere Work?
Cancer cells are abnormal cells that divide and multiply. Taxotere is a mitotic inhibitor, meaning that it works by interfering with the way the cells divide (mitosis). Specifically, this drug works by freezing microtubules in a cancer cell. Microtubules form an integral part of a cell’s skeleton, which is like a system of ligaments and muscles, but without bones. Microtubules give the cell its shape and stability and prevent it from collapsing and being damaged by external pressure and over-expansion. Theyassemble and disassemble during a cell’s growth cycle.
Taxotere binds to microtubules and causes them to stabilize in a way that blocks a cell’s growth cycle. This prevents the nucleus of the cell from diving and eventually kills the cell. The rate of cell division depends on the type of cancer cell, and doctors give chemotherapy in cycles to disable the cell’s reproductive process. In some cases, doctors combine chemotherapy drugs for maximum benefits.
Taxotere is administered through an IV for one hour every three weeks. Because the medication can cause severe allergic reactions, oral corticosteroids may be administered to minimize rashes, swelling, and other reactions during treatment. Also, the patient should only receive the drug in a facility because it can cause complications such as anaphylaxis, which may cause shock, difficulty breathing, or vomiting. The dose may be adjusted depending on the severity of the side effects.
Taxotere Side Effects
Most patients tolerate Taxotere treatment quite well. According to the label, however, the chemotherapy drug has some side effects, which vary in the degree of severity. Reactions can occur immediately after the dose or a few days later. Many Taxotere side effects are acute and treatable. The reactions can resolve on their own after treatment is over, but in most cases, doctors manage them with premedication. Either way, the chemotherapy medication can cause a few long-term side effects.
When Sanofi-Aventis began marketing Taxotere, it touted the chemotherapy medication as more effective than its competitor Paclitaxel (Onxol, Taxol). However, Taxotere has been linked to a greater number of side effects and has been shown to be more dangerous. Additionally, Paclitaxel is cheaper than Taxotere and can be used at lower doses, which means that it produces less severe adverse reactions. A study published in Cancer Treatment Reviews found that Taxotere often led to drug resistance and required doctors to prescribe higher doses.
One of the serious side effects of Taxotere is neutropenic enterocolitis, an acute condition affecting immunocompromised patients. It is characterized by transmural inflammation of the cecum, which is a pouch or large tube-like structure located at the end of the large intestine. While this condition is rare, it is life-threatening.
Other commonly reported side effects of Taxotere include:
- Low blood cell count
- Fluid retention
- Skin reactions
- Nail disorders
- Hair loss
In addition, Taxotere carries a black box warning that lists five severe or fatal complications: liver toxicity, low blood cell counts, fluid retention, hypersensitivity reactions, and toxic death.Up to 21,037 adverse events were reported to the FDA Adverse Events Reporting System from 2003 to June 2018. Of those reports, 3,000 resulted in deaths, and 17,346 were reported as serious.
Fluid retention is one of the more frequently reported side effects of the drug. The drug causes fluid buildup around the lungs and heart and in the limbs. In most cases, fluid retention is mild to moderate. Treating physicians typically give patients corticosteroids in order to prevent swelling, but fluid can buildup even after premedication. According to the drug’s label, about 6 out of 92 patients experience severe fluid retention even after taking corticosteroids. In such cases, doctors have had to draw out excess fluid from the body. Fluid retention is sometimes slow to reverse and can take about 16 weeksfrom the last treatmentto completely resolve.
Low White Blood Cell Count
Also known as neutropenia, low white blood cell count can affect patients treated with Taxotere.A more serious version is called febrile neutropenia, which is usually accompanied by fever. This condition can be serious enough to cause severe infections that require hospitalizations. Typically, white blood cell count drops in about 2 weeks after a patient receives their first chemotherapy drug.
Taxotere often triggers infusion reactions within minutes of hours of receiving the drug. Doctors usually administer glucocorticoids and antihistamines before the infusion to minimize the risk of these reactions. Some patients may experience life-threatening reactions even after premedication. Researchers think that the solvent in the infusion plus docetaxel may be causing allergic reactions. Typical infusion reactions include itching, flushing, fever, shortness of breath, and hypersensitivity reactions such as skin problems, cardiorespiratory arrest, angioedema, difficulty breathing, and wheezing.
Skin and Nail Reactions
Taxotere can cause skin reactions, including swelling and redness of the arms and legs accompanied by skin peeling. Patients with liver problems are at increased risk of severe skin toxicity. Symptoms of skin reactions typically start with tingling in the soles and palm, followed by swelling, tenderness, and blistering. Some patients may only experience skin reactions at the IV infusion site. Reaction reports indicate severe itchiness on the face, arms, feet, hands, and chest. The reported reactions happened within a week after the first treatment and were generally not disabling. In most cases, the reactions subsided before their next treatments. In clinical trials, 15 women stopped using Taxotere because of adverse skin reactions.
In addition to skin problems, Taxotere can also cause nail infections, abnormal thickening of the nails, splintering, and separation of the nail from the nail bed. Patients can use frozen gloves to reduce blood flow to the nail area. This may help delay symptoms or provide relief if they do occur.
According to a study published in the European Journal of Cancer, about 15% of breast cancer survivors who underwent Taxotere chemotherapy reporters peripheral neuropathy within 1-3 years after treatment. Peripheral neuropathy occurs when the peripheral nerves outside of the brain and spinal cord malfunction because they’re damaged.Major symptoms include tingling, numbness, and loss of reflexes in the hands and feet. Many survivorsreported that neuropathy had a significant negative impact on their quality of life. But, compared to other drugs in the same class, the side effects were much less common with Taxotere.
Studies show less than 10% of women who received Taxotere suffered the most serious neuropathy, and the severity of the side effect increased with the dose. So far, physicians have not found a lasting solution for this type of neuropathy. So they tend to watch for the symptoms during treatment and adjust the dose or delay treatment if the side effects are severe. Some doctors may prescribe an anticonvulsive to help reduce symptoms.
Symptoms of Alcohol Intoxication
In June 2014, the FDA warned that Taxotere contains alcohol, which can leave patients with symptoms of alcohol intoxication after treatment. The manufacturer revised the drug’s label to warn physicians and patients about the risk. Taxotere manufacturers use ethanol to dissolve the active ingredients so it can be administered intravenously. As such, patients should not drive or operate machinery on the day of treatment. Also, sleep aids, pain relievers, and other medications may interact with alcohol and make the effects worse.
Taxotere and Permanent Hair Loss
While chemotherapy drugs are intended to interfere with the division of malignant cancer cells, they also affect the reproduction of other fast-growing cells, including hair follicles.This is why hair loss is a common side effect experienced by cancer patients undergoing chemotherapy. It is the price that a person pays for getting rid of cancer. Most individuals grow their hair back within 3 to 6 months after treatment is stopped. However,studies have found that 8% percent of breast cancer patients treated with Taxotere experienced permanent hair loss. Although most patients go in for treatment, knowing that they will potentially lose their hair, they still have a traumatic experience when it starts to fall off. And this worsens when they learn that their hair is never coming back.
The Psychological Impacts of Permanent Hair Loss
Numerous studies have investigated the negative setback in the lives of patients with chemotherapy-induced alopecia. Research has shown that survivors face poor body image, anxiety, low self-confidence, and low self-esteem. It also affects their sexuality and social functioning. Many are never able to return to work or their life before treatment. In a smaller study, only small improvement was observed in a handful of patients who underwent treatment to stimulate hair growth. One study highlighted that an individual’s hair is a significant part of one’s identity. Due to the inability to reverse hair loss, about 40% of patients reported that they had an incredibly poor quality of life and most of them chose to wear a scarf or wig to cover their incomplete and sparse hair regrowth.
A few oncologists who understand the risk of permanent alopecia argue that breast cancer patients should worry abouthaving the disease cured at the earliest opportunity than preserving their hair. But the issue of permanent hair loss has a serious psychological aspect because most cancer survivors, hair regrowth symbolizes their victory over the illness. So, when the hair does not grow back, they may feel as if they’re experienced delayed recovery and may still be perceived as being ill, according to a study by the Rocky Mountain Cancer Centers. As such, physicians should take into account the emotionally devastating side effects of chemotherapy when deciding on the agents to use.
Sanofi’s Marketing Failed to Warn About the Potential for Alopecia
Taxotere manufacturers never mentioned the potential for alopecia until 2013, more than 15 years after the first introduction of the chemotherapy drug. But the manufacturers knew about the risk of permanent hair loss even before the drug was introduced on the market. In 1998, Sanofi funded a research study, which showed a high risk of alopecia for patients treated with Taxotere. This study, called GEICAM 9805, was not published until 2010.
The study was based on the effectiveness of Taxotere against fluorouracil (Adrucil), which is also a chemotherapy drug. Both drugs were administered in combination with two other chemotherapy drugs; cyclophosphamide and doxorubicin. While the study found that Taxotere was more effective in reducing the size of the tumor and achieving remission, researchers noted that it was more toxic. At the end of the study, it was revealed that about 96 percent of women involved in the study experienced hair loss after treatment.
Even with the knowledge about Taxotere’s connection to alopecia, the drug manufacturer continued to market the drug and claiming that it was more effective and safer than other, less toxic chemo drugs. The FDA determined that these claims were false and unsubstantiated. Studies conducted in Europe and other countries, however, disapproved the claims, and warnings began to pop up as the drug was being marketed in the U.S. Still, Sanofi did not provide this information to American oncologists and patients. In 2018, it was revealed that the drugmaker had issued a warning about permanent hair loss in the European Union and Canada in 2005. However, U.S. doctors and patients were not given the warning until 2015. Why?
The answer may not be clear, but the difference is that the U.S. healthcare system runs for the benefit of large companies, unlike those systems in other parts of the world. And the FDA has increasingly become indebted to the interests of private companies. So as the manufacturer’s marketing claims spread, the use of Taxotere in the U.S. expanded, with some doctors even prescribing it for cervical cancer and ovarian cancer patients.
FDA Taxotere Warnings
The FDA issued two warnings to Sanofi-Aventis over the marketing of Taxotere. In 2002, the agency warned the manufacturer over its promotion of Taxotere for lung cancer. In addition, the FDA issued a warning in 2009 related to the company’s promotion of Taxotere, saying that the commercials overstated the survival benefits of the drug and implied that survival depended on Taxotere treatment, while also minimizing the serious risks associated with the drug.
In a whistleblower lawsuit, a former salesperson for the company alleges that the drug was illegally marketed as the best breast cancer treatment and that Sanofi paid “kickbacks” to doctors to encourage them to prescribe it. The defendant requested the federal court in the Eastern District of Pennsylvania to dismiss the whistleblower lawsuit, but the request was denied, and the case is still ongoing.
Following Taxotere’s striking downfall, thousands of women who suffered permanent hair loss have brought a lawsuit against Sanofi-Aventis. The lawsuits are claiming that the drug maker lied about the efficacy of Taxotere and intentionally concealed the fact that it was strong. The former breast cancer patients even allege that Sanofi-Aventis offered training and bribes to employees to continue misinterpreting the effectiveness and safety of the drug. Many of the claimants also allege that the company failed to properly test the drug before releasing it to the market.
The evidence brought forth by claimants shows a very strong link between Taxotere and permanent hair loss. It’s also pretty obvious that the drug maker knew about the drug’s potential to cause alopecia but deliberately concealed the information for over 10 years. The primary ground in Taxotere mass torts in the issue of damages. In most other dangerous drug lawsuits, claimants suffer serious physical injuries such as strokes and heart attacks. By contrast, plaintiffs in Taxotere mass torts only lost their hair.
Many people may think of hair loss as somewhat trivial in comparison to organ damage or a heart attack. Other people think that breast cancer survivors should be grateful that they’re alive and get over their irreversible alopecia. But permanent hair loss can be emotionally and mentally devastating. Hair may not have so much meaning to some people, but for most of us, it is an integral part of our identity.
The bottom line is, permanent hair loss can have severe effects on the psyche, and those effects can last a lifetime. Most plaintiffs in the Taxotere litigation say that they might have chosen a different drug if they had known there was a risk of permanent hair loss. In fact, the drug manufacturershould have warned them about as early as 2005, when the labels of products in Canada and Europe were revised.
A Multi-District Litigation (MDL) is a special process in the federal court system, where a high number of pharmaceutical or product liability cases get consolidates together and assigned to one judge. An MDL can constitute hundreds or thousands of related cases.An MDL for the Taxotere permanent hair loss lawsuits and mass torts was formed in October 2016. Given similar questions of fact raised in the lawsuits, all Taxotere cases in Federal Courts are centralized in the Eastern District of Louisiana before Judge Jane Triche Milazzo. The MDL also includes over 350 cases that were granted mass tort status in the New Jersey Supreme Court in August 2018. The defendants in the Taxotere cases include Sanofi-Aventis (the manufacturer), Pfizer, Accord Healthcare, Hospira Worldwide, Sandoz, Sun Pharmaceuticals, and Actavis, all of which distributed or sold the drug under a license or in generic form.
The size of the MDL continues to grow exponentially.When it was established, there were about 5,500 cases. A year later, almost 2,000 claims were filed. As of August 2019, there are over 9,100 cases claiming that high-potencyTaxotere left women with permanent, disfiguring alopecia after breast cancer treatment.The judge established a bellwether program to help involved parties to have an idea of how juries are likely to respond to evidence.The first bellwether trial was scheduled for May 2019 but was later postponed to September 16, 2019.No settlement has been made, and the drug manufacturer has not announced any intentions to settle the cases. The highly anticipated verdicts will give a better insight into the potential value of Taxotere cases.
Find a Taxotere Mass Tort Near Me
Putting a monetary value on intangible losses is a great challenge in injury lawsuits and torts. Losses such as emotional distress, anxiety, and pain and suffering are considered to be “non-economic” damages.” It is difficult to put a dollar value on mental anguish, but it’s nevertheless a factor that can diminish a person’s quality of life in the same manner as a debilitating injury.
If you were previously prescribed Taxotere and suffered permanent hair loss, you may be able to join a mass tort to fight and seek damages for the psychological harm that was done to you. The dedicated dangerous drugs experts at Consumer Alert Now can review your case, answer your questions, and walk you through the steps of the Taxotere mass tort. We can connect you to experienced attorneys who can help you hold Sanofi accountable for what they did and what they failed to do.
Call us today at 800-511-0747 or contact us online to learn more about Taxotere mass torts, or to set up a free consultation.