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Taxotere

 

Taxotere and Permanent Hair Loss

Were you or a loved one prescribed Taxotere for chemotherapy treatment after diagnosis of breast cancer?  Did you or your loved one experienced permanent hair loss (lasting at least 6 months after completion of chemotherapy)? You may be entitled to financial compensation for your injuries.

What is Taxotere?

Originally manufactured by Sanofi-Aventis, Taxotere (docetaxel) is a chemotherapy drug used to treat breast cancer, as well as other forms of cancer. The drug is part of class of drugs called taxanes and works as an anti-mitotic. This means it interferes with cellular division, thus stopping breast cancers. Given that roughly 300,000 women are diagnosed with breast cancer every year, it was a huge money-maker for Sanofi. The company made more than $3 billion from Taxotere in 2009 alone. Sanofi no longer has patent protection for the drug, so other companies can offer generic forms.

Taxotere is typically given with other drugs like cisplatin, fluorouracil, capecitabine, cyclophosphamide and doxorubicin to treat breast cancer and increase patients’ survival rates. Taxotere is a favorite of doctors - being the most prescribed taxane for breast cancer treatment. Based on the typical treatment plan, it’s also a favorite of many patients.

Taxotere, like many chemotherapy drugs, is given intravenously. However, Taxotere infusion lasts only one hour and is only administered once every 3 to 4 weeks. Other taxanes, like paclitaxel (also known as Taxol and Onxol), must be given weekly and the infusions take several hours. Given this, women often prefer Taxotere, even though studies have proven that paclitaxel works just as well with less serious side effects. Despite this fact, Sanofi marketed Taxotere as more effective than paclitaxel. Also worth noting is that doses of paclitaxel can be lower than those of Taxotere with the same effect. The lower doses mean there are fewer serious side effects. Taxotere is also more expensive than paclitaxel.

What is the Problem with Taxotere?

Taxanes in general come with a long list of potential - and often very unpleasant - side effects, including:

  • Pain in muscles and joints
  • Constipation or diarrhea
  • Weakness and fatigue
  • Increased risk of infections
  • Fluid retention with weight gain, abdominal and/or ankle swelling
  • Anemia (low red blood cell count)
  • Leukocytopenia (low white blood cell count)
  • Sores in the mouth or throat
  • Nausea
  • Changes in the sense of taste
  • Changes in the color of fingernails or toenails
  • Peripheral neuropathy (numbness or pain in the extremities, often the feet)
  • Hair loss (all hair on the body, head and face)

Unfortunately for some breast cancer patients treated with Taxotere, there is one side effect that is actually disfiguring. Taxotere has been linked to permanent hair loss, also known as alopecia. This condition has lasted for a decade or longer in roughly 9% of women treated with Taxotere. It is true that the majority of women are willing to temporarily endure hair loss for a chance at beating breast cancer.

Alopecia takes this total hair loss to a new and disturbing level, though. The hair loss is permanent. While, as with other taxanes, there may still be patches of fuzz or random strands of hair left after treatment with Taxotere, the hair never regrows. Quite often, women who suffer from Taxotere-related alopecia shave their heads, as do many women who are treated with paclitaxel.

Again, similar to other women who deal with chemotherapy-related temporary hair loss, those with Taxotere-related alopecia seek out ways to hide their baldness, such as:

  • Hats
  • Scarves
  • Wigs
  • Expensive hair implants of the type usually used to treat male pattern baldness

Sadly, insurance companies consider all of these “remedies” to be cosmetic and so do not cover them. This leaves women who have fought - and beat - a deadly disease and who may have exhausted their financial resources due to treatment and co-pays to cover these expenses themselves. While there is some help for lower-income women, such as the National Alopecia Areata Foundation that operates a special fund to buy wigs for women who can’t afford them, there is a limit to the sources of help available.

Make no mistake: Taxotere-related alopecia is a disfiguring condition. Due to the strong media focus on how women should look and what makes women attractive, Taxotere-related alopecia can cause serious psychological trauma. Many women no longer feel attractive and many lose their spouses who can’t deal with the alopecia. This serious negative impact on body image can lead to depression, distress and a significant reduction in the quality of the breast cancer survivors’ lives.

Not only do women who suffer from Taxotere-related alopecia deal with these difficult after-effects, permanent hair loss is not a cosmetic issue. Every day, these brave women must look in the mirror and constantly be reminded of their battle with breast cancer. They are robbed of the chance to “move on,” to have closure and return to their normal lives.

FDA Action

In December 2015, the U.S. Food and Drug Administration (FDA) issued a warning via a safety information page disclosing the risk of permanent hair loss related to breast cancer treatment with Taxotere. Some women allege that Sanofi knew of the risk and warned other countries about it much earlier than 2015.

A lawsuit filed in March 2016 alleges that the company issued warnings to health care providers and breast cancer patients in Europe as far back as 2005 and those in Canada in 2012. However, Sanofi remained silent on the issue in the U.S. until about a month after the FDA’s warning. In fact, an article was published in the Globe and Mail in Canada in March 2010 reporting on women’s attempts to get Sanofi to tell them why it hid the risk of Taxotere-related alopecia.

Studies

Sanofi has no good answer for any of the women who have been permanently affected by Taxotere-related alopecia. Several studies, one sponsored by Sanofi, showed a link between Taxotere and permanent hair loss.

The GEICAM 9805 study was sponsored by Sanofi in the late 1990s. The results were available by 2005 and this study showed that 9.2% of women treated with Taxotere suffered permanent alopecia.

Another study, this one conducted by Dr. Scot Sedlacek from the Rocky Mountain Cancer Centers in 2006, showed similar results to the GEICAM 9805 study. Dr. Sedlacek’s study showed that treatment with Taxotere could cause over 6% of patients to suffer permanent hair loss.

In 2008, Lemieux et al. published a review of 38 articles dealing with the effects hair loss had on breast cancer patients. They examined issues such as quality of life as it related to body image, distress, anxiety, social functioning, sexuality, the ability to go back to work and self-esteem. The results of this review showed that “hair loss consistently ranked amongst the most troublesome side effects, was described as distressing, and may affect the body image.”

A 2012 study by Klugel et al. was published in the Annals of Oncology. This study tracked 20 breast cancer patients being treated with Taxotere. Every patient suffered permanent alopecia and all attempts at treating the condition were unsuccessful. The best outcomes were sparse, clumpy and incomplete hair regrowth.

When the authors compared the study participants to a healthy population of women, they found that the study participants exhibited “significant impairment” of the quality of their lives. Results showed that 40% of the participants suffered “severe impairment.” One woman went so far as to tell the authors that “‘she would have preferred not to receive any chemotherapy for her breast cancer’ rather than being affected by such a distressing and permanent side-effect.” Roughly 70% of the study participants covered their heads with scarves or wigs.

Yet another study, this one dealing with the differences in effectiveness and safety of Taxotere and paclitaxel, was published in Cancer Treatment Reviews. The study showed that Taxotere treatment didn’t have any better results or benefits than paclitaxel. It also showed that patients often became resistant to Taxotere, which meant their doctors had to continually prescribe higher, more toxic doses.

BreastCancer.org published a study in 2008 showing that more than 89% of the 5,000 participants who were treated with Taxol had a higher rate of survival than those who received Taxotere.

Taxotere and Permanent Hair Loss Lawsuits

Several lawsuits have been filed against Sanofi alleging that the company knew of the risk of Taxotere-related alopecia and withheld the information from health care providers and patients. The plaintiffs also allege that Sanofi lied by telling the public that the hair loss was not permanent. Other allegations include:

  • Selling Taxotere without proper testing
  • Failure to determine Taxotere’s safety
  • Making a dangerous drug
  • Downplaying the risks associated with Taxotere treatment

The Judicial Panel on Multidistrict Litigation (JPML) issued an order on October 4, 2016 that consolidated these lawsuits into a multi-district litigation (MDL). The purpose of the MDL is to handle all of the pre-trial proceedings (discovery, etc.) at one time, thus saving the parties time and money and avoiding the risk of contradictory pre-trial decisions. The MDL is being handled in the Eastern District of Louisiana, Judge Lance M. Africk presiding.

Don’t Wait! The Time is now to Seek Legal Assistance!

If you or a loved one has been diagnosed with permanent alopecia related to Taxotere treatment for breast cancer, now is the time to seek legal assistance. The Statute of Limitations, the time period during which you can file a lawsuit, may already be running. If you wait too long, you will be forever barred from seeking the justice you deserve. Contact the experienced attorneys at Justinian and Associates now for a free case consultation. We are experienced in dealing with dangerous drug lawsuits and MDLs and we will fight for you.

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