The Truth About TAXOTERE
Taxotere is a chemotherapy drug manufactured and marketed by Sanofi-Aventis that is commonly used in the treatment of certain cancers, including breast cancer. Taxotere received FDA approval in 1996 for breast cancer treatment and has since been used by many patients for cancer treatment. However, Sanofi-Aventis failed to warn doctors and patients of the risk of permanent hair loss. Had Sanofi-Aventis properly warned doctors and patients, they could have chosen an equally effective alternative medication that did not carry this risk. In December 2015, the FDA updated the label to include the warning about the risk of permanent hair loss.
Before December 2015, the Taxotere label misled patients and doctors in stating that “hair generally grows back” after all treatments are completed. For almost 20 years, from 1996, when the FDA first approved Taxotere to 2015, when the FDA changed the label, patients were misinformed about the true risks of the drug. In fact, patients were told the exact opposite – that hair generally grows back. The overwhelming weight of evidence suggests that Taxotere leads to permanent hair loss.
In 2006, oncologist Dr. Scot Sedlacek studied Taxotere’s effect on 112 patients. The results showed an estimated 6.3% suffered permanent hair loss. In 2010, doctors at Boston University and Tufts University reviewed the case of women with permanent hair loss citing Taxotere as the “implicated agent.” Another study in 2011 in England and Italy looked at the charts of 8,430 patients treated for Alopecia (hair loss) over a span of seven years. Only seven were determined to have chemotherapy induced permanent hair loss. Five of those seven patients were treated with Taxotere. Also in 2011, French physicians reported in the Annals of Oncology that there was a “comprehensive series of patients with permanent diffuse and irreversible scalp alopecia and body hair loss” after undergoing chemotherapy treatment that included Taxotere.
Sanofi-Aventis was aware of the risk because its own studies showed that 9% of patients experience permanent hair loss. Indeed, in Europe, Taxotere’s marketing information referenced possible “persistent alopecia” since 2005. These same warnings were not used in the United States until 2015.