April 7, 2017 — French health regulators are investigating Taxotere after five people died of neutropenic enterocolitis, which is caused by the drug’s most common side effect.
Taxotere (docetaxel) is a chemotherapy drug made by Sanofi Aventis. The company is accused of failing to warn about side effects in 800 lawsuits involving women who went permanently bald after treatment.
France’s top health agency ANSM warned that neutropenia is the most frequently reported side effect of Taxotere, but the number of deaths was unusual and alarming. Even so, ANSM is not banning Taxotere yet. The agency’s director told Medscape:
A risk–benefit assessment will need to be made if it is decided to withdraw docetaxel from the market, to suspend its marketing. This is presently being looked at.”
Neutropenic enterocolitis is a known side effect of Taxotere, estimated to occur in 1 in 10,000 patients. It causes severe inflammation of the intestine and it is associated with neutropenia (low white blood count).
The five fatalities all occurred after August 2016 and involved patients between 46 and 73 year old who used a generic version of Taxotere. The product lot in question tested negative for any abnormalities.
The Institut Curie in France has stopped using Taxotere and switched to Taxol (paclitaxel). Both belong to the taxane class of chemotherapy drugs, but Taxotere is more potent than Taxol.
Taxotere is also more likely to cause side effects like permanent hair loss. Women in hundreds of lawsuits say they would have chosen Taxol if they had known Taxotere might cause them to suffer baldness.
Taxotere is recommended for women with fast-growing metastatic breast cancer. However, studies show that up to one-third of breast cancers are slow-growing and do not need aggressive treatment. The number of Taxotere lawsuits tripled since December 2016, with most of the lawsuits centralized in MDL No. 2740 in Louisiana.
Sanofi Aventis is accused of failing to warn American women about the risk of baldness until December 2015. The warning labels on Taxotere in Canada were updated in 2005 and in Europe in 2012.
Sanofi got more bad news in January, when a federal judge in Pennsylvania refused to dismiss a whistleblower lawsuit filed by a former sales representative. The company is accused of training reps to downplay the risk of side effects from Taxotere.
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