After being informed of the occurrence of 6 cases of enterocolitis (an inflammation of both the small intestine and the colon), 5 of which led to the death of patients with breast cancer and treated with docetaxel, the National Medicines Safety Agency (ANSM) opened a pharmacovigilance investigation.
This is in the process of being finalized and will be presented to the Technical Pharmacovigilance Committee on March 28.
The drug has not been withdrawn
The women who died as a result of their treatment ranged from 46 to 73 years old. They were treated with docetaxel, as monotherapy or in combination. Three deaths were recorded last August, a fourth in November 2016 and a fifth in February 2017.
“The quality of the drug batches was immediately checked and found to comply with the specifications of the marketing authorization (AMM)” underlines the ANSM in a letter to health professionals.
Read also: Breast cancer: one in two women suffers from the side effects of treatment
For now, drugs containing this molecule have not been suspended and “in the absence of additional investigative elements making it possible to assess the benefit / risk ratio in the context of breast cancer treatment” no recommendation is made. The ANSM stresses, however, that paclitaxel can constitute an alternative to docetaxel.
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