0 805 04 01 10: a toll-free number to “answer questions” from patients treated with Androcur® has been set up. Many questions regarding the risk of brain tumors with this drug, most often used off-label.
The Medicines Agency has issued recommendations to patients and healthcare professionals concerning Androcur, a medicine which increases the risk of certain tumors in the event of long treatment and at high doses.
In particular, a toll-free number to “answer questions” from patients treated has been set up. “This number (0 805 04 01 10) is accessible free of charge from Monday to Friday from 9 a.m. to 7 p.m.”, indicates the ANSM. The patients are also invited “to consult their doctor, without urgency, to discuss the interest of the continuation of their treatment and to evaluate the realization of possible additional examinations”.
#Androcur and risk of meningioma: Establishment of a toll-free number to answer questions from patients or those around them
?? More information: https://t.co/jvaQZsKG6p pic.twitter.com/t2oxw812iR
– ANSM (@ansm) September 20, 2018
After 3 pillse and 4e generation, it is the turn of Androcur® to be the subject of a new drug crisis, or even a future health scandal. Thanks to the relentlessness of neurosurgeons who made the link between this drug and the increased risk of meningioma early on (10 years ago anyway!), An investigation was carried out by the ANSM and it reveals that this anti-androgen quite commonly prescribed off-label as contraceptive or treatment for acne and endometriosis, multiplies by 7 the risk of meningioma after 6 months and by 20 after 5 years of treatment.
A risk of meningioma multiplied by 20
On his website, the National Medicines Safety Agency (ANSM) recognizes that since 2009, “cyproterone acetate has been the subject of 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 leaflet of the medicinal product in 2011 “.
According to one pharmaco-epidemiological study conducted by the Health Insurance in collaboration with the neurosurgery department of Lariboisière, the risk of meningioma is multiplied by 7 for women treated with high doses over a long period (more than 6 months) and by 20 after 5 years of treatment . There is, in fact, a strong relationship between dose and effect, the risk being multiplied by more than 20 beyond a cumulative dose of 60 g, i.e. approximately 5 years of treatment at 50 mg / d or 10 years of treatment at 25 mg / d (when the treatment is taken for 20 days per month).
Figures that could be underestimated: Doctors do not always remove tumors, as some may regress after stopping treatment and others may go unnoticed for a long time. According to the French Health Insurance study, more than 500 women taking Androcur or one of its generics underwent an operation for a meningioma between 2007 and 2015.
An anti-androgen especially prescribed “off-Marketing”
Belonging to the class of steroidal anti-androgens, cyproterone acetate, the active substance in Androcur, is normally used to treat prostate cancer or hirsutism, an extreme development of hair growth, at a dose of 50 mg per day. In addition, cyproterone acetate is indicated at a dose of 100 mg per day in the treatment of paraphilias. But that’s not its only use.
Androcur and its generics are regularly prescribed to women suffering from intractable acne, endometriosis or as contraception (especially in cases of hyperandrogenism). However, Androcur has never received validation of these last three indications from the health authorities (marketing authorization or “Marketing Authorization”): these are “non-Marketing Authorization” prescriptions, that is. that is to say not validated, even if some scientific publications allow doctors to believe that cyproterone acetate is effective there.
A scandal more than a problem
The risks concerning the drug have been known for a long time (2008), doctors are already informing patients but they can always be criticized for not doing enough, and especially since the majority of prescriptions seem to be off-label. Already, many voices are raised to ask why Androcur® and its generics continued to be prescribed to long-term patients for acne “with more or less hair”.
In a survey cited by the HAS in 2012 (IMS survey), when the reimbursement was renewed, hirsutism and prostate cancer only represented 30% of prescriptions! The numbers may have changed, but it would be good if they were provided to us.
Androcur has been the subject of special monitoring since 2009 by the EMA and the notification of the risk of meningioma is on the drug leaflet, with a contraindication in the event of a history or presence of a meningioma. In terms of patient information, this is considered the minimum!
A scandal following that of the Diane 35® pill
Finally, cyproterone acetate is the principle that is also contained in the Diane 35® pill, a pill that hit the headlines due to an increased risk of phlebitis and pulmonary embolism, or even stroke.
Studies have shown that the risk of venous thromboembolism is 1.5 to 2 times greater in users of Diane and 3rd and 4th generation pills than in users of combined oral contraceptives (COCs) containing levonorgestrel. From this point of view, the risk of thromboembolism with Androcur® is clearly indicated in the package leaflet, but some studies and literature reviews state that the thromboembolic risk would be lower.
“Patients and healthcare professionals can report any adverse reaction suspected of being linked to a drug, directly on the declaration portal of the ministry in charge of health”: signaling-sante.gouv.fr
A toll-free number, 0 805 04 01 10 is now in place to “answer questions from patients” … and try to defuse the crisis.
.
