This drug multiplies by 7 the risk of brain tumor after 6 months and by 20 beyond 5 years of treatment.
Vigilance around the drug Androcur is increasing. Health insurance and the National Agency for the Safety of Medicines and Health Products (ANSM) have jointly sent a letter to more than 80,000 patients, 30,000 private doctors and 2,000 health establishments to warn of the risks of brain tumor (or “meningioma”), reveals The Parisian. An exceptional measure, which was only taken for the Pick and the Dépakine.
A form to sign
Even in the absence of mail, all patients under Androcur are encouraged to consult their doctor. From July 1, patients will be required to sign a form informing them of the risks of the treatment and will be systematically presented to them by their doctor. “The prescriber will have to say whether the drug is given within or outside the marketing authority (AMM). It has also been made clear that this certificate does not in any way constitute a discharge of liability. The reverse would be the height”, specifies Alain-Michel Ceretti, president of France Assos Santé.
From now on, brain imaging by MRI will have to be performed at the start of treatment for all patients. In case of continuation of treatment, the MRI will have to be renewed at five years, then, if all goes well, every two years. “Physicians are also asked to contact their patients currently being treated with Androcur or generics to reassess the need to continue their treatment and consider an MRI check-up if continued treatment is decided,” the health agency said. “If a meningioma is discovered, the treatment must be stopped definitively. A neurosurgical opinion is recommended”, she adds.
New recommendations
In addition, new recommendations have been made. Off-label indications such as acne will henceforth be prohibited. The use of Androcur in children and postmenopausal women is no longer recommended. The prescription of the drug will also have to be reassessed annually taking into account the individual benefit / risk ratio and the evolution of symptoms, and prolonged use and high doses are now to be banned.
A toll-free number (0 805 04 0110) to “answer questions” from treated patients has also been set up. It is accessible free of charge, Monday to Friday, from 9 a.m. to 7 p.m.
Thanks to the relentlessness of neurosurgeons, who made the link between Androcur and the increased risk of meningioma, an ANSM investigation revealed last September that this drug multiplied by 7 the risk of meningioma after 6 months and by 20 beyond 5 years of treatment.
Cyproterone acetate
On his websitethe National Medicines Safety Agency (ANSM) indicates that, since 2009, “cyproterone acetate has been subject to special monitoring following the signal issued by France at European level on the risk of the appearance of meningioma. The evaluation of this signal by the European Medicines Agency (EMA) led to this risk being included in the drug’s leaflet in 2011”.
Belonging to the class of steroidal anti-androgens, cyproterone acetate, the active ingredient of Androcur, is normally used to treat prostate cancer or hirsutism, extreme hair growth, at a dose of 50 mg per day. Androcur and its generics are also regularly prescribed to women suffering from stubborn acne, endometriosis or as contraception (especially in cases of hyperandrogenism).
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