Docetaxel, sold under the brand name Taxotere, a chemotherapy drug used to treat breast, lung, prostate, stomach, and head and neck cancer, is already being sued by more than 700 patients in the United States over allegations that the drug causes permanent alopecia, or hair loss. Now this same drug is facing even more allegations of serious side effects.
US Recall News reports that the French National Drug and Health Product Safety Agency (ANSM) is investigating Taxotere/docetaxel in response to a report that shows the drug connected to five deaths in only six months. Patients using a generic version of docetaxel died of neutropenic enterocolitis, also known as typhlitis, which is an inflammation of the cecum, a part of the large intestine that is located near the appendix. It is associated with a low level of neutrophil granulocytes (the most common form of white blood cells) in the blood; docetaxel kills these types of white blood cells. This condition can lead to death as it can cause bowel perforation and sepsis.
Medscape reports that all of the fatal cases were connected to generic docetaxel manufactured by Indian pharmaceutical company Accord Healthcare (Intas Pharmaceuticals). The ANSM has already determined that this generic version “is fully in accordance with the standards,” and the quality of the docetaxel lots was approved.
In light of that information, the ANSM launched a pharmacovigilance investigation of all docetaxel-based therapies, the results of which are expected to be released on March 28, 2017.
“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,” explained ANSM head Dr. Dominique Martin.
Meanwhile, the Institut Curie, in Paris, decided not to wait on the ANSM recommendation and has already replaced docetaxel with paclitaxel.
“As a precaution, given the occurrence within an unusually short period of time, of these two similar cases at the Institut Curie and those at other health care facilities in France, the Institut Curie has stopped using docetaxel to treat breast cancer. It has been replaced with paclitaxel,” reads the press release dated Feb. 16, 2017.