Five patients in France have died from neutropenic enterocolitis following treatment with a generic version of Taxotere (docetaxel). The fatalities have prompted the French National Drug and Health Product Safety Agency (ANSM) to launch an investigation, while the Institute Curie in Paris is using paclitaxel in place of docetaxel as a precautionary measure.
Neutropenic enterocolitis occurs when a part of a large intestine called the cecum becomes inflamed. If not treated immediately, the condition may result in bowl perforation or death.
All five fatalities occurred since August 2016 in patients (ages 46 to 73) who had been treated with a version of docetaxel manufactured by Accord Healthcare. According to a report published by MedScape, neutropenic enterocolitis is the most common adverse effect observed with docetaxel. However, the number of deaths reported in France over such a sort period of time is unusual
No issues have been found as to the quality of the docetaxel lots implicated in the fatalities, and testing has not uncovered any issues with the generic version of Taxotere. For now, ANSM is not recommending that marketing of docetaxel be suspended.
“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,” ANSM general director Dominique Martin explained, according to MedScape.
Taxotere was approved by the U.S. Food & Drug Administration (FDA) in 1996 to treat breast cancer, and is now indicated for the treatment of head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer. The first generic version of docetaxel was approved by the agency in 2012.
Hundreds of Taxotere lawsuits have been filed in U.S. courts on behalf of patients who allegedly experienced permanent alopecia due to its use. While hair loss is a typical side effect of chemotherapy, plaintiffs pursuing these claims allege that alopecia from Taxotere is more likely to be permanent compared to other, equally as effective agents. Mention of permanent alopecia as a possible Taxotere side effect was only added to drug’s U.S. labeling in December 2015. However, plaintiffs contend that Sanofi-Aventis has long provided information regarding the potential for permanent hair loss to individual patients and regulatory agencies overseas.
The majority of Taxotere hair loss claims have been centralized in a federal multidistrict litigation that is now underway in the U.S. District Court, Eastern District of Louisiana. Court documents indicate that 837 cases were pending in the Eastern District of Louisiana as of February 17, 2017.