Permanent alopecia (hair loss) is a rare but devastating side effect of Taxotere. In recent years, a number of lawsuits have been filed by women who say Sanofi-Aventis failed to warn about the risk until the FDA required label changes in December 2015.
What is Alopecia?
Hair loss is also known as alopecia. Anti-cancer drugs destroy all rapidly-growing cells, including hair follicles and cancer cells. Alopecia begins within 7-10 days of the first treatment and increases during the first month or two. The amount of alopecia varies by patient and some chemotherapy drugs cause more than others. In most cases, hair starts growing back within 3-6 months after the last treatment ends.
What is the problem?
Taxotere is a “last resort” medication for people with locally advanced or metastatic breast cancer when other chemotherapy treatments have failed. It is very potent, but the problem is that it is also very toxic.
Hair loss is one of the most common side effects of chemotherapy, but permanent alopecia is not. Unfortunately, recent studies suggest that Taxotere (docetaxel) may increase the risk of alopecia.
Permanent alopecia can have a devastating effect on a patient’s self-esteem and quality of life. Recent studies have found that nearly half of women consider alopecia to be the most traumatic side effect of chemotherapy, and 8% would refuse chemotherapy over fears of hair loss.
FDA Adds Permanent Alopecia to Taxotere Label
In December 2015, the FDA updated the label on Taxotere to include warnings about permanent alopecia. Within months, Sanofi-Aventis was hit with several lawsuits from women who say they were not adequately warned about this side effect.
Studies Link Taxotere and Alopecia
Plaintiffs say Sanofi-Aventis knew or should have known about the risk of permanent alopecia long before the FDA update. In the late 1990s, the drug-maker sponsored a study known as GEICAM 9805. By 2005, the study found that 9.2% of patients suffered permanent alopecia.
In 2006, Dr. Scott Sedlacek of the Rocky Mountain Cancer Center conducted another study that found 6.3% of breast cancer patients grew back less than 50% of their hair after being treated with a combination of Taxotere (docetaxel), Adriamycin (docorubicin) and Cytoxan (cyclophosphamide).
Taxotere Alopecia Lawsuits
In March 2016, a woman who experienced permanent hair loss filed a Taxotere lawsuit (PDF) against Sanofi-Aventis in federal court in Illinois. She says she would have considered other chemotherapy treatments had she been adequately warned about the risk of permanent alopecia:
“Although women might accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer, this was not the case. … [T]here were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia as does Taxotere.”