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A chemotherapy drug, Taxotere has been prescribed to treat certain cancers, the most notable being breast cancer. However, in more recent years, researchers have discovered a correlation between Taxotere use and permanent hair loss, and in response, plaintiffs have come forward to file lawsuits against manufacturer Sanofi-Aventis.
Background
The FDA approved the drug generically known as docetaxel in 1996 to treat metastatic and adjuvant breast cancer. Since then, 75 percent of all breast cancer patients have taken it, while others diagnosed with prostate, non-small cell lung, head, neck, and advanced stomach cancer have also used it within their treatment plans. In all cases, Taxotere works by blocking the spread and growth of cancer cells within the body.
Yet, not long after the drug’s approval, multiple studies revealed a correlation between taxotere usage and permanent alopecia. The first, in fact, was the manufacturer’s own, titled GEICAM 9805. In it, Sanofi-Aventis sponsored a study that compared Taxotere to other chemotherapy drugs for metastatic breast cancer; while research began in the 1990s, a 10-year follow-up revealed 9.2 percent of patients experienced permanent hair loss.
By 2006, a study at Rocky Mountain Cancer Centers found that 6.3 percent of patients given Taxotere in combination with Adriamycin (docorubicin) and Cytoxan (cyclophosphamide) grow back less than 50 percent of their body hair.
In 2009, the FDA issued a warning concerning a reprint carrier, which cited a study in the Journal of Oncology that compared Taxotere to Taxol. The communication called out misleading promotional materials that claimed, without sufficient supporting evidence, one drug is safer than the other.
A year later, a study published by the American Academy of Dermatology supported these initial findings, citing the increasing number of patients complaining of permanent hair loss.
More studies fueled the fire over the next few years. A 2012 study in the Journal of Clinical Oncology pointed to a higher risk of serious side effects associated with newer cancer drugs, which included Taxotere. Researchers found more incidents of nerve damage, heart problems, diarrhea, skin issues, and high blood pressure, and discovered that patients given a newer chemotherapy drug were 40 percent more likely to die from a side effect than if they took a placebo. Then, in 2013, a study from the National Cancer Research Institute discovered that permanent alopecia may occur in anywhere from 10 to 15 percent of all patients given Taxotere.
By 2014, the FDA put out yet another warning, this time as the result of the growing reports concerning alopecia. As Sanofi’s drug label claimed hair would grow back, the government organization required the manufacturer to revise its warning to state that permanent alopecia is a potential side effect.
Lawsuits
In the claims filed so far, plaintiffs allege the lack of warning prevented them from making an informed decision regarding their healthcare. Further, they claim they’re living with an avoidable condition.
Along with these statements, lawsuits state that Sanofi made an effort to update doctors in Canada and Europe several years before the U.S., where doctors didn’t receive a formal warning until 2016.
