Drugs Xagena
Following a Europe-wide review of Cyproterone acetate with Ethinylestradiol ( Co-cyprindiol ), the balance of benefits and risks of Dianette ( brand leader ) and its generics remains positive. To further improve the benefit-risk balance some important changes have been made to clarify the indication.
Although the indications for Co-cyprindiol relate to androgen-sensitive skin conditions and hirsuitism, the medicine also provides effective contraception for women who require it. Use of additional hormonal contraception with Co-cyprindiol is therefore contraindicated. The risk of venous thromboembolism is rare, but healthcare professionals and patients should remain vigilant for signs and symptoms of this important side effect.
Cyproterone with Ethinylestradiol is licensed as a second-line treatment for women with severe acne or moderately severe hirsutism. A review of the benefits and risks of Co-cyprindiol was initiated in January 2013 following concerns in France about the risk of venous thromboembolism ( VTE ) and off-label use as a contraceptive. The review has concluded that the balance of benefits and risks of Co-cyprindiol remains positive; however, some important changes to product information for prescribers and women have been made to further improve this balance.
New information wording
Indication for use - The review considered the available data on the safety and efficacy of Co-cyprindiol and concluded that it should be used in women of reproductive age for the treatment of: skin conditions related to androgen sensitivity, such as severe acne with or without seborrhoea; hirsutism.
Co-cyprindiol should only be used when treatment with topical therapy or systemic antibiotics has failed.
Contraceptive action - Co-cyprindiol provides effective contraception in women who require it to treat androgen-sensitive conditions, but it should not be used solely as a contraceptive.
Review of postmarketing data for adverse drug reactions has suggested that some women are using Dianette as well as a combined hormonal contraceptive. This exposes them to twice the dose of oestrogen and substantially increases their risk of venous thromboembolism. Use of an additional hormonal contraceptive with Co-cyprindiol is therefore contraindicated.
Rare risk of venous thromboembolism - The risk of VTE with Co-cyprindiol is rare and similar to that associated with the hormonal contraceptive pills. The available observational data have limitations, but taken together their findings provide sufficient evidence that Co-cyprindiol has a 1.5-2 times statistically significant increase in VTE risk ( deep vein thrombosis, DVT, or pulmonary embolism, PE ) compared with Levonorgestrel-containing pills. Although more limited, the available evidence also suggests that the VTE risk with Dianette is likely to be similar to that with contraceptives that contain Desogestrel, Gestodene, or Drospirenone.
Duration of treatment - In 2008 MHRA ( Medicines and Healthcare Products Regulatory Agency ) published updated advice on the recommended duration of use of Co-cyprindiol. The recent review has confirmed that acne is a chronic condition that requires at least 3 months of treatment with Dianette to relieve symptoms, and that prolonged treatment might be needed. The need to continue treatment should be evaluated periodically by the treating physician.
Advice for healthcare professionals
The benefits of Co-cyprindiol outweigh the risks in women of reproductive age for the treatment of: skin conditions related to androgen sensitivity ( eg, severe acne with or without seborrhoea ); hirsutism.
Co-cyprindiol provides effective contraception in these women. An additional hormonal contraceptive should not be used in combination with Co-cyprindiol.
The need to continue treatment should be evaluated periodically by the treating physician.
The risk of VTE is rare but this remains an important side effect, and healthcare professionals should themselves be vigilant for signs and counsel patients to remain vigilant for signs and symptoms. These include: DVT: unusual leg pain ( usually in the calf ), which may be accompanied by tenderness or swelling in the leg; increased warmth, redness, or discolouration of skin; PE: sudden sharp chest pains ( which may increase with breathing in ); shortness of breath ( which can come on suddenly or gradually ); sudden coughing for no apparent reason; severe light-headedness, dizziness or fainting. ( Xagena2013 )
Source: Drug Safety Update 2013 vol6, issue 11: A3
XagenaMedicine_2013
