Dr Sarah Branch, the MHRA’s Deputy Director for Vigilance and Risk Management of Medicines, said: “The European Medicines Agency (EMA) has finished its review of the safety of Diane 35 – known as Dianette in the UK – and its generics and has concluded that the benefits continue to outweigh the risks, which are already well known.

 

“In the UK, Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive undesirable hair in women. The review by the EMA found that the risk of venous thromboembolism (blood clots) 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. If any woman has questions about her treatment she should contact her doctor.”

 

Posted on the UK MHRA website on 30 May 2013