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Taxotere

2017-05-24T10:20:06+00:00

What is Taxotere?

Taxotere is a chemotherapy drug approved by the FDA for the treatment of various cancers including – but not limited to – breast cancer, stomach cancer, non-cell small lung cancer, head and neck cancer, and forms of prostate cancer. Taxotere falls within the family of drugs referred to as taxanes and it administered intravenously to prevent cancer cells from multiplying.

The Risk – Permanent Hair Loss 

Taxotere, a chemotherapy drug commonly used to treat breast cancer, has been linked to permanent hair loss in breast cancer patients. Sanofi-Aventis, the drug’s manufacturer, is accused of failing to warn both patients and the prescribing physicians about the risks of permanent hair loss (alopecia) when taking the drug Taxotere. Although hair loss is common with chemotherapy, it is temporary, whereas Taxotere carries a risk of causing permanent hair loss. It was not until the FDA ordered Sanofi-Aventis in December 2015 to update Taxotere’s safety label to reflect risk of permanent hair loss that it was disclosed to the public.

The Argument

The victims, those who were prescribed the drug prior to December 2015, were not given the opportunity to choose an alternate drug to avoid the risk of permanent hair loss. The FDA ordered Sanofi-Aventis to update the label to include disclosure of this risk after receiving post-marketing reports of permanent hair loss from patients on Taxotere. However, prior to the update, the label on Taxotere stated that “hair generally grows back” once chemotherapy treatment has been completed. Research estimates that nearly 10 percent of Taxotere patients have experienced persistent or permanent hair loss.

Taxotere was originally marketed as a stronger and more effective alternative to Taxol, its rival. The medical community, over the last decade, has learned that this claim cannot be validated. In fact, in 2009, the FDA warned Sanofi-Aventis of the marketing materials where they were claiming Taxotere was superior to Taxol (paclitaxel) in the treatment of patients with locally advanced or metastatic breast cancer. The FDA’s letter declared that there was not “substantial evidence or substantial clinical experience to support these claims.” However, it is feared that doctors who were not aware of the lack of evidence supporting the claims may have continued to favor the drug in treating breast cancer patients without knowledge of the additional risk of permanent alopecia from Taxotere.

For some chemotherapy patients, the most traumatic side effect of cancer treatment is hair loss. Statistics show that this is especially true for female patients. Some women indicated that they would possibly reject lifesaving chemotherapy to avoid the associated temporary hair loss. Statistics have also shown that even temporary hair loss can cause both psychological damage and emotional distress for patients. It is widely believed that if patients had been informed of the life-altering risk, many would have chosen an alternative drug which did not carry the risk of permanent hair loss.

To learn more about the effects of Taxotere or to schedule a free consultation with one of our attorneys regarding your particular case, please contact us today.