The benefits of an acne drug outweigh its risks of blood clot formation, according to a safety review by European Union experts.
The European Medicines Agency review of Diane 35 (cyproterone acetate 2mg/ethinylestradiol 35micrograms) – known as Dianette in the UK – and its generics was sparked in February by concerns raised in France.
A national review by France’s Agency for the Safety of Medicine and Health Products highlighted serious thromboembolic events and extensive off-label use of the drugs as contraceptives. It subsequently decided to suspend the product’s marketing authorisation in France.
The EMA’s review confirmed there was a “rare and known risk” of venous thromboembolism with Dianette and its generics.
It found the risk of VTE was 1.5 to two times higher than for combined oral contraceptives containing levonorgestrel, and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
The review also showed the excess risk of VTE was highest during the first year of use of Dianette or when restarting or switching from an oral hormonal contraceptive after a pill-free interval of at least one month.
However, the EMA concluded that the benefits of Dianette outweighed the risks, provided that several measures were taken to minimise VTE risk.
For example, because it acts like hormonal contraceptives, women should not take it in combination with other hormonal contraceptives, as this would expose patients to a higher dose of oestrogen and increase VTE risk.
In addition, it said the drug should be used solely in the treatment of moderate to severe acne related to androgen sensitivity or hirsutism in women of reproductive age, and should only be used after alternative treatments, such as topical therapy and antibiotic treatment, had failed.
The EMA added that educational materials should be given to prescribers and patients highlighting the risks of VTE – such as a prescriber checklist to ensure the risks and their signs and symptoms were discussed with the patient.
The recommendations will be sent to the European Commission, which will adopt them as a legally binding decision.
The UK’s Medicines and Healthcare products Regulatory Agency highlighted that “Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive undesirable hair in women”.
Dr Sarah Branch, the MHRA’s deputy director for vigilance and risk management of medicines, said: “The review by the EMA found that the risk of VTE is rare but it remains an important side-effect for healthcare professionals to monitor and women to be aware of.
“Our advice is that there is no need for a woman who is feeling well to stop taking her medicine,” she added.
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