Docetaxel (Taxotere) is a chemotherapy drug originally approved by the US Food and Drug Administration (FDA) in 1996 for the treatment of breast cancer, but has since been granted expanded indications for treatment of head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer.
Chemotherapy has long been associated with temporary hair loss. Taxotere, however, has been linked with permanent hair loss in a growing number of patients and plaintiffs who have filed Docetaxel side effects lawsuits.
Taxotere gained a foothold in the chemotherapy sector as an effective treatment for breast cancer and other indications, with the added benefit of fewer treatments overall within a slightly compressed treatment window – without any additional side effects, or so it was claimed. Patients encountered hair loss, which is normal during chemotherapy, but with the expectation that hair would, in most cases, grow back – a widely-held expectation.
Taxotere patients, however, found to their chagrin that Docetaxel hair loss turned out to be permanent in many instances. In rare cases – including one in Canada – hair loss has extended to all areas on the human body where hair is normally found, including eyebrows.
Taxotere hair loss plaintiffs assert that Taxotere manufacturer Sanofi SA, based in France, was aware as early as the late 1990s that research existed suggesting a 9.2 percentage of Taxotere patients having experienced hair loss lasting for a period of years – up to a decade – following treatment with Taxotere.
Plaintiffs assert that warnings on the product label prior to 2015 were “generic, vague and insufficient” with an indication that “hair generally grows back.”
Plaintiffs assert it wasn’t until December, 2015 – just over a year ago – that product labels noted any risk for permanent Taxotere alopecia (hair loss) in the US. It is alleged that warnings about the potential for permanent hair loss were available in Europe for some time prior to the US product label update.
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While the FDA mandated Sanofi SA to update the Taxotere product label in the US with the potential for permanent hair loss, the regulator previously warned in June of 2014 that Taxotere is formulated with alcohol. Thus, patients using intravenous Taxotere had the potential for experiencing symptoms of intoxication during treatment, and following.
It should be noted that a Pretrial Order issued by the US District Court, Eastern District of Louisiana on January 11 of this year clarifies that the scope for multidistrict litigation over Taxotere alopecia will encompass both generic versions of Docetaxel, as well as medication branded as Taxotere.