AVEP Press release
The European Union wants to strengthen the supervision of the prescription of DIANE 35.
In its report published on 17/05/2013 the European Pharmacovigilance Risk Assessment Committee (PRAC) confirms DIANE 35 should be prescribed « only for the treatment of acne and hirsutism » and « when antibiotics have failed », stating that « better information on risks » must be given.
The PRAC confirms that this product should never be used as a contraceptive.
In France, the victims of Diane 35 or their families will be satisfied to read this confirmation and will therefore ask their doctors explanations of off-label prescriptions.
The advice given by the Committee on Pharmacovigilance must be validated by the
Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, » CMDh, and then apply to all countries in the European Union: this is potentially a significant step forward for the safety of women as today there are unfortunately many countries where DIANE 35 is allowed to be marketed as a contraceptive although the excess risk has been well known and validated for many years.
The European Pharmacovigilance Risk Assessment Committee (PRAC) confirmed a positive risk / benefit ratio in very limited cases of dermatological treatment: therefore it did not follow the request of the French Agency for the Safety of Health Products (ANSM) that was intended to protect women from abusive prescriptions observed as soon as the product was marketed in 1987, strongly supported by a very active marketing manufacturer BAYER: how will the EMA and health agencies now control that doctors implement this reminder of good practice?
Health agencies and doctors should be held accountable to the victims or their families for these long known abuses, favored by the manufacturer BAYER and denounced for over two years by the AVEP.
The Office of the AVEP (Association of Victims of Pulmonary Embolism and stroke caused by hormonal contraception)