The shipment is massive. More than 80,000 patients, 30,000 private doctors and 2,000 healthcare facilities are in the process of receiving this mail, as confirmed by the Health Insurance. Cosigned by the latter and the ANSM, policeman of the drug in France, it is addressed to those, or rather – because it is the great majority – to those who consume or have consumed Androcur or its generics.
The authorities, because of the regulations, could not trace the patients who had a prescription more than two years ago. Marketed by the laboratory Bayer, "it is an effective drug for the treatment of certain conditions, but can promote the development of meningioma," reads the document.
Multiplies by seven the risk of meningioma
The risk of these brain tumors, most often non-cancerous, continues the letter, is multiplied by seven beyond six months of treatment, by twenty for prolonged use and in large doses! "You are invited to consult your doctor", is it written in bold.
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Marketed against hyperpilosity or the treatment of prostate cancer, Androcur is, in fact, mainly delivered as a contraceptive pill, anti-acne or as a cure for endometriosis … Fortunately, since the first alert of the ANSM, in September, these diverted uses tend to be largely reduced.
Contacting all patients who have taken a drug is an exceptional procedure. This was only seen for the Mediator and for the depakine, this antiepileptic which can cause malformations for the children who are exposed in the belly of their mother.
Six further procedures to come
"This mail, satisfactory, is the least for patients," says Alain-Michel Ceretti, the boss of France Assos Health, federation of users who participated in the development of the document with the ANSM, associations, the doctors…
As of July 1st, doctors will have to have their patient sign a form informing them of the risks. "The prescriber will have to say whether the drug is given in or outside the marketing authority (MA). It has also been made clear that this certificate does not constitute, in any way, a release of liability. The opposite would be the height, "continues Ceretti.
Meanwhile, the legal proceedings, led by Mr. Charles Joseph-Oudin continue. The first three referred expert must be examined by the court of Bobigny on 13 September. Three others have been sent to justice and three more are in the process of being.
She contracted a brain tumor because of the drug Androcur