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Taxoterelinked to permanent hair loss in women

Taxotere Lawsuit

Taxotere is a popular chemotherapy drug that is commonly prescribed to breast cancer patients. Taxotere has been linked to alopecia, a disease which causes permanent hair loss.  Taxotere manufacturer, Sanofi, failed to warn consumers of all the risks associated with the chemotherapy drug, in some cases even hiding research and evidence from the public. There is currently a Taxotere lawsuit filed on behalf of all women who developed alopecia or experienced similar adverse effects as a result of Taxotere.

 

What is Taxotere?

 Taxotere (active ingredient: docetaxel) is manufactured by Sanofi-Aventi. Taxotere was first approved by the FDA in May 1996. Taxotere is used to treat an array of cancers but is most commonly prescribed to treat patients with locally advanced or metastatic breast cancer, which had progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy. Taxotere is also used as an adjuvant treatment in combination with doxorubicin and cyclophosphamide for individuals with operable node-positive breast cancer. The drug works in stopping the spread of cancerous cells by cutting off the dividing and multiplying of cells in and around a cancerous clump. Taxotere falls under a specific class of chemotherapy treatments called taxane drugs – made from plant alkaloids.

Taxotere has also been approved to treat non-small cell lung cancer (NSCLC), prostate cancer, head and neck cancers, and stomach cancer (gastric adenocarcinoma).

Taxotere is primarily used to treat women with breast cancer. Taxotere is the most prescribed drug in its class (taxane) – some sources estimate that 75% of breast cancer patients will receive Taxotere as a form of treatment.

Unlike similar chemotherapy drugs with weekly treatment plans, Taxotere’s treatment plan runs at three-week intervals. Fewer trips to the doctor for treatment makes Taxotere more attractive to both patients and doctors.

Taxotere has also been approved for administration outside of the hospital (in 60-100 mg/m2 doses). Similar chemotherapy treatments require hospitalization to cope with extended infusion times.

Common side effects include:

–        Diarrhea –        Peripheral neuropathy
–        Fatigue –        Muscle, joint and bone pain
–        Fluid retention –        Low platelets
–        Temporary Hair loss –        Liver problems
–        Infections –        Nail changes (discoloration)
–        Mouth sores –        Nausea

As is warned on the Taxotere label, toxic death occurs in around 2% of metastatic breast cancer patients and about 11.5% of patients with other tumor types with abnormal liver function who are using Taxotere.

 

Taxotere- Dangers, Side Effects and Injuries

Along with the more common side effects, there are also more life-threatening adverse effects associated with Taxotere.

Taxotere carries a black box warning for several known adverse health effects associated with the drug.

These black box adverse health effects include:

  • Toxic Death– increased risks for patients with abnormal liver function, patients prescribed higher doses, patients suffering from NSCLC and prior platinum-based therapy recipients.
  • Hepatotoxicity– liver damage caused by chemical exposure due to Taxotere treatment. Common in patients with abnormal liver function or elevated LFT, hepatotoxicity can because severe complications and even be life-threatening
  • Fluid Retention– Taxotere’s label warns that the condition may reach severe levels for some patients
  • Neutropenia– Low neutrophils (specific white blood cell) count, making patients more likely to contract bacterial infections. If gone untreated, these bacterial infections can cause severe health conditions and even death. Patients with neutrophil counts under 1500 cells per 3 cubic millimeters of blood volume are more susceptible to develop neutropenia and are advised against using Taxotere unless necessary. Doctors are advised to frequently check blood counts for these patients who do use Taxotere.
  • Hypersensitivity Reactions– including but not limited to rash, low blood pressure, and fatal anaphylaxis. Patients who received dexamethasone premedication are most susceptible to developing these conditions.

 

Side effect not included on Taxotere label – Alopecia

The Taxotere label does mention temporary hair loss as a known side effect of the drug, as is the case with most chemotherapeutic treatments. Studies find that among all of the side effects associated with chemotherapy, temporary hair loss has the greatest impact on a patient’s quality of life.

While the label does make patients aware of the potential risk of temporary hair loss, it fails to warn about the possibility of permanent hair loss.

Alopecia is a permanent and irreversible hair loss disease which affects all body hair, including eyebrows, eyelashes, facial hair, and pubic hair. Multiple studies have found that Taxotere use can result in alopecia, although it is not labeled a known side effect.

Evidence of alopecia occurring in Taxotere patients includes:

  • Documents from Sanofi funded GEICAM 9805 study – which was presented as evidence in an ongoing litigation against Sanofi, that reveal that around 9.2% of patients suffered hair loss that lasted more than a decade.

 

  • 2006 study conducted by the Rock Mountain Cancer Centers – found that Taxotere caused 6% of women to suffer permanent alopecia.

 

  • 2012 study published in the Annals of Oncology – of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for reoccurring breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth. But after using Taxotere, she suffered from permanent hair loss.

Alopecia can severely affect a person’s quality of life, affect body image, jeopardize well-being, and cause depression and distress. For women who already have to struggle with the burden of breast cancer and chemotherapy, developing alopecia can be devastating.

For breast cancer survivors, alopecia is more than a cosmetic effect. The disease is a constant reminder of these women’s struggles to fight breast cancer. The 2012 study published in the Annals of Oncology found that women who suffered from alopecia due to Taxotere suffered “significant impairment” to their quality of life.

 

Taxotere Lawsuit

 A growing number of women and their families have begun filing lawsuits against Taxotere manufacturer Sanofi, claiming that the manufacturer was aware of the increased risks of alopecia but failed to warn consumers. The plaintiffs also claim that Sanofi hid data and research that linked Taxotere to these unlabeled adverse side effects.

In fact, Sanofi did warn consumers outside of the U.S. that Taxotere could be linked to “permanent hair loss” and even “alopecia” but failed to warn U.S. consumers

Evidence presented in current litigations against Sanofi indicate that the manufacturer tried to downplay the known risks in order to get the drug approved in 1996. The plaintiff makes accusations of employee training that incorporates teaching misrepresentation of safety and effectiveness, and alleged illegal payments in the form of “kickbacks” to doctors who prescribed Taxotere.

The lawsuit goes on to claim that Sanofi actually misled the U.S. public through advertising and marketing that assured Taxotere users that hair loss was only temporary and that there was no threat of permanent hair loss.

Sanofi also failed to recognize in-house data collected from the GEICAM 9805 study, which indicated that around 9.2% of patients suffered hair loss that lasted more than 10 years. Sanofi did not recognize the findings of Dr. Scott Sedlack of the Rocky Mountain Cancer Centers, whose findings indicated that 6% of women using Taxotere developed permanent alopecia.

While studies indicate that Taxotere is an effective chemotherapeutic treatment, the lawsuit complaint argues that other treatments, which are at least as effective as Taxotere, do not subject consumers to the same risks of permanent hair loss.

 

Timeline of Taxotere approvals, studies, and Taxotere Lawsuit

May of 1996 Initially approved for use by the FDA.
June of 1998 Approved for first-line treatment of metastatic breast cancer in subjects whose disease has recurred despite adjuvant therapy.
December of 1999 Approved for use as an injection to treat patients suffering from locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
August of 2004 Approved for use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of women with operable node-positive breast cancer.
May of 2004 Approved for use in combination with prednisone for the treatment of metastatic, androgen-independent prostate cancer.
October of 2006 Approved for use in combination with cisplatin and fluorouracil for patients being treated for inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).
March of 2006 Approved for use in combination with cisplatin and fluorouracil for patients being treated for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy.
December of 2006 Study conducted by the Rock Mountain Cancer Centers – found that Taxotere caused 6% of women to suffer permanent alopecia.
December of 2010 Release of documents from Sanofi funded GEICAM 9805 study –revealed that around 9.2% of patients suffered hair loss that lasted more than a decade.
May of 2012 Study published in the Annals of Oncology – of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for reoccurring breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth. But after using Taxotere, she suffered from permanent hair loss.
June of 2014 FDA issues a safety communication about the potential for patients to experience intoxication during or after the use of Taxotere due to the presence of ethanol in docetaxel.
December of 2015 Consumer warning of potential side effect of alopecia included on the Taxotere label for the first time.
October of 2016 33 lawsuits consolidated in the Eastern District of Louisiana as the initial Taxotere MDL.
January 28 of 2019 first Taxotere lawsuit trial scheduled for hearing in the Eastern District of Louisiana.

Do you qualify to participate in the Taxotere lawsuit?

 Currently, there is a multidistrict litigation consolidated in the Eastern District of Louisiana. The Taxotere lawsuit is comprised of women who developed alopecia after using Taxotere.

If you currently suffer from a permanent hair loss disease and were previously prescribed Taxotere, contact the office of TorHoerman Law for a free no obligation evaluation and Taxotere lawsuit consultation today.

Our firm works on a contingency basis, so we are just as dedicated as you are of making sure that you are fully compensated for your Taxotere injuries. Our dedicated team of pharmaceutical lawyers will be here to help you every step of the way, answer any questions you may have and walk you through the steps of your Taxotere lawsuit.

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