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Taxotere Baldness Lawsuit

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Permanent baldness is a rare but serious side effect of the chemotherapy medication Taxotere. Sanofi-Aventis is facing a growing number of lawsuits for downplaying this risk, despite their own studies estimating that up to 9% of patients experience persistent hair loss.

Overview

Chemotherapy medications cause baldness because they destroy all rapidly-growing cells, including cancer cells as well as hair follicles. Temporary hair loss is a normal side effect of cancer treatment, but permanent baldness is not.

Permanent Baldness Added to Taxotere Label

Sanofi-Aventis, the manufacturer of the breast cancer drug Taxotere (docetaxel), is accused of misleading patients and the medical community about the risk of permanent baldness. Until recently, the Prescribing Information (PDF) reassured patients that “hair generally grows back” after completion of treatment. After dozens of women did not re-grow their hair, the FDA updated the label on Taxotere to include permanent baldness (also known as alopecia).

Evidence Linking Taxotere and Baldness

Taxotere is a “last resort” medication for women with severe metastatic breast cancer after other treatments have failed. Taxotere is very powerful, but also very toxic, especially when combined with other chemotherapy medications.

In the 1990s, Sanofi-Aventis sponsored a study known as GEICAM 9805 that found 9.2% of women (49 patients) experienced permanent baldness after they were given Taxotere plus doxorubicin and cyclophosphamide.

Another study published in 2006 by Dr. Scott Sedlacek of the Rocky Mountain Cancer Center found that up to 6.3% women who were given Taxotere experienced persistent baldness, especially when they were also given doxorubicin and cyclophosphamide. He concluded:

“Such an emotionally devastating long-term toxicity from this combination must be taken into account when deciding on adjuvant chemotherapy programs in women who likely will be cured of their breast cancer.”

Warning Signs & Symptoms

Hair loss typically begins within 1-2 weeks of starting cancer treatment and increases during the first couple months. Hair should start growing back within 3-6 months of starting treatment. Patients may experience:

  • Sensitive scalp and itching
  • Finding hair on the pillow in the morning
  • Hair falling out in clumps
  • Hair loss when shampooing or brushing
  • Gradual thinning hair, especially at the crown
  • Changes in texture or color of regrown hair
  • Regrown hair is shorter (stops growing at 10-cm)

Taxotere Baldness Lawsuits

Breast cancer patients who experienced permanent baldness after treatment with Taxotere have filed lawsuits accusing Sanofi-Aventis of downplaying the risk. One lawsuit (PDF) was filed in federal court in Illinois in March 2016. The plaintiff is a woman with breast cancer who suffered from disfiguring permanent alopecia after receiving Taxotere in 2005. According to the complaint:

“Thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning. … Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

 

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