The investigation carried out after the death of 47 patients treated with docetaxel concludes that the quality of the drugs is not in question.
The pharmaceutical quality of docetaxel-based products complies with French and European requirements. But as a precaution, the Medicines Agency (ANSM) and the National Cancer Institute (INCa) recommend maintaining the temporary suspension of use in women suffering from metastatic breast cancer.
This opinion delivered at the end of April by the two health agencies is based on the pharmacovigilance survey carried out on the territory, and the clinical analysis of the 47 deaths linked to this anticancer drug between 1996 and 2017. They were arrested last August by several cases of fatal enterocolitis.
In this new information point published on May 2, the ANSM indicates that the analyzes carried out on the incriminated batches (originator and generics), in particular the dosage in active principle and the presence of impurities, did not present any anomalies. In addition, generic drugs are of the same quality as the originator.
1 case of enterocolitis per 10,000 patients
The pharmacovigilance investigation also confirms that serious side effects such as colitis or septic shock are rare. Between 1996 and February 2017, 600,000 patients with different cancers received docetaxel. Of these, 187 suffered side effects, of which 47 died, including 16 women with breast cancer. Also, deaths remain rare, on the order of 1 per 10,000 exposed patients.
These serious cases have been reported twice: the first time in 2010, then between 2015 and 2016, “without any cause of this increase having been identified and without any signal specific to a specialty or to a indication could not be highlighted ”, raises the ANSM.
An “individual susceptibility”
For its part, INCa advances the explanation of “individual susceptibility”. According to their analysis, a significant number of complications occurred during the first treatment between the 4e and the 10e day. “The signs may seem harmless enough to only lead to a delayed consultation request,” note oncologists.
In the light of this information, they believe that it would be useful to pay particular attention to the comorbidities of the patients before prescribing this class of drugs. Growth factors should be systematically associated, and the dose of corticosteroids should be reassessed.
Good practice recommendations should be issued in the coming months on the place of taxanes (docetaxel and paclitaxel). In the meantime, the temporary suspension of the use of these products has not been lifted.
At the same time, the pharmacovigilance investigation is continuing in order to study all the undesirable effects of docetaxel, and its alternative, paclitaxel. A European assessment is also underway.
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