For experts, the adverse effects linked to this molecule are known and described. There is therefore no need to maintain his suspension.
Docetaxel may again be used in the treatment of metastatic breast cancer. The National Cancer Institute (INCa) and the National Medicines Agency (ANSM) have just lifted the suspension of use issued as a precaution in February 2017. This was decided after the occurrence of 5 deaths in patients with breast cancer treated with docetaxel.
At the end of April, an ANSM investigation showed that 47 deaths recorded between 1996 and 2017 are linked to this anticancer drug. Over the same period, 600,000 patients in France received it.
According to the various investigations, the pharmaceutical quality of docetaxel-based products complied with European requirements and no specific product could be incriminated. But at the time, no lifting of the ban had been mentioned.
The agencies were awaiting the conclusions of a European assessment. This work presented in June to the experts “does not show an increase in the frequency of serious adverse effects and deaths linked to this molecule”, indicate the agencies in a press release, adding that “the increase in the number of cases declared in France could be linked to an increase in the vigilance of health professionals ”.
Do not deprive patients
Aware that enterocolitis is a known and described serious side effect of these drugs, health agencies and oncologists have nevertheless spoken out in favor of lifting the ban. “Like many other anticancer drugs, these molecules have side effects and their use carries risks. INCa and ANSM consider that these must be taken into account and anticipated, but must not deprive patients of these effective drugs ”, indicates the press release.
INCa should issue an expert opinion in the coming months for healthcare professionals to describe the role of taxanes (docetaxel and paclitaxel) in the treatment of breast cancer and the procedures to be followed for the management of certain effects. potentially serious adverse reactions.
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