The chemotherapy drug Taxotere has been linked to five fatal cases of neutropenic enterocolitis, an inflammation of the mucosa of the small intestines and colon, the French National Drug and Health Product Safety Agency (ANSM) reports. As a result, the Institut Curie in Paris has stopped using the drug in favor of paclitaxel.
Neutropenic enterocolitis is also known as typhlitis, an inflammation that affects the cecum, a part of the large intestine near the appendix. It is associated with a low level of neutrophil granulocytes, the most common form of white blood cells. Taxotere targets and kills these types of cells. Neutropenic enterocolitis can be deadly if it perforates the bowel and leads to sepsis.
The five fatalities were reported since August 2016. The patients were between the ages of 46 and 73, and each were treated with a generic version of Taxotere, called docetaxel, as part of a combination therapy in the context of adjuvant or neoadjuvant treatment for breast cancer.
Taxotere is manufactured by Sanofi-Aventis. The generic docetaxel the patients received was manufactured by the Indian pharmaceutical company Accord Healthcare (Intas Pharmaceuticals). The ANSM reported that the quality of the docetaxel lot revealed no issues that would increase the risk of death in patients who received the product.
Taxotere is used to treat breast, lung, prostate, stomach and head and neck cancer. The drug is linked to permanent alopecia, or hair loss. At least 2,300 people in the U.S. are suing Sanofi-Aventis for failing to adequately warn of Taxotere side effects. The cases are consolidated into a multidistrict litigation under U.S. District Judge Kurt D. Engelhardt in the Eastern District of Louisiana.