If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
DIANE 35 SIDE EFFECTS SKIN
However, when used for acne, they should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.
Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk-minimisation measures, including changes to the information to prescribers and patients, are implemented. This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.ĭespite the PRAC recommendation, ANSM proceeded with the suspension of the marketing authorisation of these medicines in France. The French decision followed a national review of the medicine by ANSM.
The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months. Because the CMDh took this position by majority, it will now be sent to the European Commission, which will adopt a legally binding decision. These recommendations have been endorsed by the CMDh, a body representing European Union (EU) Member States. These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient. However, to minimise this risk, further measures should be implemented in addition to the updated product information. The risk of thromboembolism occurring with these medicines is low and well known. Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism. Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives. Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.
These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human ( CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee ( PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
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