The public health department of the Paris prosecutor’s office has opened a preliminary investigation after the death of three patients hospitalized at the Nantes University Hospital.
A preliminary investigation was opened, Friday, November 18, by the public health pole of the Parquet of Paris for “involuntary homicides and involuntary injuries” after the almost simultaneous death at the Nantes University Hospital of three patients.
These patients, aged 61 to 65, had cancer of the blood cells (lymphoma), and had been treated with intensive chemotherapy and autologous transplantation since the end of October. They died between November 10 and 13 of “serious complications”. A fourth, who was receiving the same treatment, aged under 40, has been in intensive care since Tuesday, November 15.
Warned by the Regional Health Agency of the Pays de la Loire on Thursday, November 17, the Minister of Health immediately dispatched to Nantes a mission of the General Inspectorate of Services (Igas). The latter will have to make its first conclusions within seven days.
Supply tensions
If it is for the moment impossible to determine the reason for these three deaths, the investigators are particularly interested in the cocktail of drugs administered to these patients as part of their chemotherapy. It included “the drug cyclophosphamide in replacement of the drug melphalan generally used”, specified the Ministry of Health.
There is nothing exceptional about this substitution, however, since it has been validated by the medical community. It is linked to supply tensions at European level for melphalan. Moreover, the Minister of Health declared in front of the Senate Friday that “at this stage, nothing allows to accuse the cyclophosphamide, treatment validated by the medical community and used for years”. The spectrum of “potential causes is wide”, she added, citing as possible causes “drug, protocol, mode of administration …”.
No adverse effects were detected in a fifth patient, who received the same treatment with the same preparation and according to the same protocol, according to Benoît Vallet, Director General of Health (DGS). The first reports from regional pharmacovigilance centers collected by the National Medicines Safety Agency also did not report any similar accident in France.
Known heart complications
This drug is developed by the American pharmaceutical group Baxter under the name Endoxan. A spokesperson for the group said that three products from other laboratories were part of the chemotherapy protocol. She also recalled that Endoxan, marketed in France since 1994, is commonly used in hospitals.
However, according to Benoît Vallet, Endoxan is “known to give cardiac complications, very rare, but listed”. This drug gave three patients “an intense cardiac effect, leading to death”. “The sequence of three patients who die in a few days (…) actually leads us to think that we are in an unusual situation,” he said on France Inter.
.
