Amavea, an association of victims of Androcur, a drug that causes tumors, filed a criminal complaint in Paris against X to denounce the “bankruptcy“actors responsible for the safety of this medication, the lawyer and president of the association told AFP on Thursday, November 7.
“It is now obvious that the actors in charge of the safety of Androcur – Health Agency, laboratories, doctors – failed in the management of the side effects of this drug“, wrote Me Charles Joseph-Oudin and Emmanuelle Mignaton, president of Amavea, in a press release on this complaint revealed by Le Monde on Thursday morning.
“Amavea, representative of thousands of victims, wants an investigation to be carried out to determine the negligence committed and establish the responsibility of the actors involved“, they continued, requesting the appointment of an investigating judge.
According to the complaint, “from 1998, cases of meningiomas were regularly reported to laboratories marketing Androcur“.
Theoretically indicated against excessive hair growth, but prescribed for decades by many doctors well beyond these indications – for example against endometriosis – the link of the drug Androcur (cyproterone acetate) with meningiomas has been clearly established in 2018.
Meningiomas are tumors of the membranes that surround the brain. These tumors are sometimes referred to as “benign“, because they are not likely to degenerate into fatal cancers, but they can cause serious neurological disabilities.
For Me Joseph-Oudin and Ms. Mignaton, “this additional risk, identified by the laboratory in 2004, was then recognized by the firm and the ANSM (medicine safety agency, Editor’s note) in 2008/2009. However, no information was communicated to prescribing health professionals or patients before 2019“.
This year only, “the Health Authority and the Laboratory put in place a risk management plan which included, among other things, the dissemination of targeted information to patients taking Androcur“, they criticized.
The criminal complaint, filed Tuesday and of which the AFP became aware, targets the offenses of administering a harmful substance, involuntary harm to the integrity of the person, endangering others, failure to report an adverse effect and aggravated deception.
Androcur prescriptions fell by almost 90% between January 2018 and December 2023, according to the ANSM. At the end of November 2023, fewer than 10,000 patients were treated with Androcur compared to around 90,000 at the end of 2017.
