Drug maker Sanofi-Aventis has been hit with yet another Taxotere lawsuit, this time in Colorado. Like other legal cases involving the chemotherapy medication, this complaint claims that Sanofi-Aventis concealed information about the drug’s association with permanent alopecia (hair loss).
Brought to market in 1996, Taxotere belongs to a powerful class of cancer drugs called taxanes. It is used in conjunction with other chemotherapy agents to treat several types of cancer, including locally advanced or metastatic breast cancer after prior chemotherapy attempts have failed. While many chemotherapy drugs are known to cause temporary hair loss, the U.S. prescribing information for Taxotere was updated just last year to note that cases of permanent alopecia have been reported among patients treated with the medication.
According to a complaint filed in the U.S. District Court, District of Colorado on March 30th, Melissa F. Leith, was administered Taxotere from February 2013 through April 2013 as part of her breast cancer treatment. Since then, she has suffered from disfiguring, permanent alopecia. The complaint alleges that neither Leith nor her doctors were told that Taxotere-related hair loss could be permanent. Since alternative and equally effective medications were available, Leith asserts that she was deprived of a chance to make an informed decision about her treatment.
“Before Defendants’ wrongful conduct resulted in thousands of women being exposed to the side effects of docetaxel (TAXOTERE), there were already similar products on the market that were at least as effective as docetaxel (TAXOTERE) and did not subject female users to the same risk of disfiguring permanent alopecia as does docetaxel (TAXOTERE),” the complaint states.
The lawsuit claims that Sanofi-Aventis was aware for years that Taxotere could cause long-term hair loss, but did nothing to warn patients or doctors. Among other things, the complaint cites a 2005 Sanofi-sponsored study known as EICAM 9805, which found that almost one out of every 10 patients who received Taxotere experienced hair loss for up to a decade or more. The following year, a Denver-based oncologist reported that 6.3% of patients he treated with Taxotere suffered permanent alopecia.
Finally, Leith claims that Sanofi did advise regulators elsewhere, including those in the European Union and Canada, that Taxotere was associated with an increased risk of permanent hair loss. However, the drug’s U.S. label included only a generic, vague, and insufficient warning that “hair generally grows back” after taking Taxotere.