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About Taxotere

taxotereChoosing the right combination of drugs is never easy for chemotherapy patients and their doctors due to the number of side effects associated with cancer treatment. The matter is further complicated when drug manufacturers are not candid about known risks associated with their products. Research has shown that 3-16% of Taxotere users have suffered permanent hair loss, but the label did not always contain this particular warning.

A number of former Taxotere users say that the emotional damage stemming from permanent baldness is “worse than cancer” and are filing lawsuits against manufacturer Sanofi-Aventis.

Docetaxel (sold as Taxotere or Docecad) is a well-established chemotherapy drug first approved by the FDA in 1999 for the treatment of advanced or metastatic breast, head, neck, gastric, hormone-refractory prostate, and non-small-cell lung cancers. The ingredients interfere with cancer cell division processes and can be used as a single agent or in combination therapy. The World Health Organization has put it on their “Model List of Essential Medicines.”

What are the side effects of docetaxel?

Like most drugs targeting advanced cancers, docetaxel comes with a long list of side effects. Nearly all users will experience some hair loss, low white blood cell counts and anemia with use. More than half of docetaxel patients stop menstruating during therapy, retain fluid, and suffer random bouts of temporary hearing or vision loss. Diarrhea, mouth swelling and sores, nausea, insomnia, and nail changes affect nearly half of all users.

Ten percent of patients suffer more severe hypersensitive reactions like hemorrhages, gastrointestinal cramping, throat pain, rashes, fever, chills and chest tightness. Risk of death from complications of Taxotere is less than 2%, but a 2012 study published in the Journal of Clinical Oncology found that newer cancer drugs like Avastin, Taxotere and Sutent carry a slightly higher risk of serious side effects than older drugs.

Docetaxel hair loss

Can Taxotere cause permanent hair loss?

Yes, according to the manufacturer’s own studies, 3% of users experienced long-term alopecia (baldness). Reports of Taxotere hair loss rose as high as 6.3% when used in combination with other drugs like Adriamycin (doxorubicin) and Cyclophosphamide, according to a study by the Rocky Mountain Cancer Centers in Colorado. 

Can Taxotere hair loss be treated?

No – so far there is no effective therapy for chemotherapy-induced hair loss. A 2012 study of twenty Taxotere patients published in the Annals of Oncology found that the hair loss from Taxotere use had “distressing psychological consequences in the patients’ lives,” and could not effectively be treated with vitamins, minoxidil, psoralen, ultraviolet A therapy or spironolactone. 

What does the FDA say about Taxotere and hair loss?

In December 2015, the FDA acknowledged that “cases of permanent alopecia have been reported.” Prior to a label change, official prescribing information stated: “Loss of hair occurs in most patients taking Taxotere (including the hair on your head, underarm hair, pubic hair, eyebrows, and eyelashes). Hair loss will begin after the first few treatments and varies from patient to patient. Once you have completed all your treatments, hair generally grows back.”

Taxotere lawsuits

The first Taxotere lawsuits have started showing up in courts around the country, following the FDA announcement and label change. The lawsuits are based on the grounds that the manufacturer “failed to warn” physicians and patients of “known risks” associated with Taxotere. While it is not illegal to release a drug with side effects to market, manufacturers are legally bound to notify the public of the risks, so patients and their doctors can make informed decisions regarding treatment.

However, in light of the fact there are comparable therapies that do not have permanent baldness as a side effect, some plaintiffs are also contending that Taxotere has a “defective design” – that its increased potency causes an unnecessary toxicity. The reason many patients choose Taxotere over Taxol is to have four cycles instead of twelve. Yet, a 2008 study published in the New England Journal of Medicine identified better outcomes in patients taking Taxol (paclitaxel) than those using Taxotere. A year later, the FDA warned Sanofi-Aventis that they must cease promoting the “superior efficacy” of their product, in light of these findings.

At this time, there have been no Taxotere settlements. It could take several years for individual hearings to go before a judge or for coordinated litigation to prompt settlement talks. Each state has its own statute of limitations for filing a product liability lawsuit, which is why it’s crucial to speak with an attorney about legal options as soon as possible.

Docetaxel permanent alopecia resources