A growing number of product liability lawsuits over Taxotere hair loss are being filed in courts throughout the U.S., alleging that women who underwent breast cancer chemotherapy involving the drug have been left with permanent alopecia, which has continued for years after hair was expected to regrow.

Taxotere (docetaxel) is a cancer drug approved by the FDA in May 1996, as a more potent version of another breast cancer treatment that was already on the market.

Although Sanofi-Aventis suggested that Taxotere was superior to lower potency taxane-based drugs, the lawsuits allege that it is actually no more effective than the earlier treatment options, yet carries a high risk that users may be left with permanent hair problems; a risk that is not associated with other breast cancer drugs.

One of the latest cases against Sanofi-Aventis was brought last week by Yvonne Bemiss, alleging that the drug maker not only failed to warn about the potential link between Taxotere and hair loss side effects that may continue for years after treatment is over, but actively hid the risks from the medical community in its effort to promote their newer drug.

According to the complaint (PDF) filed in the U.S. District Court for the Eastern District of Louisiana on May 17, Bemiss underwent chemotherapy including use of Taxotere after she was diagnosed with ductal carcinoma of the right breast in early 2010. Although it was expected that her hair would regrow during the months following chemotherapy, Bemiss indicates that she continues to experience problems with hair loss years later, indicating that she was unaware of the risk associated with Taxotere until this year, when other lawsuits and various reports started to become public.

The case is joins of a growing number of Taxotere hair loss lawsuits filed in courts throughout the U.S., each involving similar allegations that safer alternative breast cancer treatments were available, which do not carry the same risks, yet Sanofi-Aventis pushed doctors to use their high potency drug and withheld information about the risk of permanent hair loss.

Bemiss and other plaintiffs point to a study published in 2005, known as GEICAM 9805, which found that nearly 10% of patients who took Taxotere suffered permanent hair loss that continued for over 10 years after treatment. The manufacturers were aware of that study, as well as published of observations by a Denver-based oncologist in 2006, which indicated that more than 6% of his Taxotere patients suffered permanent hair loss.

“Defendants have chosen to withhold this information in the United States despite advising physicians, patients, and regulatory agencies in other countries, including the European Union and Canada, that Taxotere causes an increased risk of permanent disfiguring hair loss,” the lawsuit states. “Defendants instead continued to warn or advise physicians, healthcare providers, patients and Plaintiff in the United States only with the generic, vague, and insufficient warning that ‘hair generally grows back’ after taking Taxotere.”

Bemiss presents claims of design defect, inadequate warning, and breach of warranty.

Tags: Alopecia, Breast Cancer, Chemotherapy, Hair Loss, Sanofi-Aventis, Taxotere