- Prescribing Advice for GPs - https://www.prescriber.org.uk -

MHRA Dianette Update

The Medicines and Healthcare products Regulatory Agency has issued an update on the use of Dianette®. The MHRA are currently reviewing the description of psychiatric reactions in the product information.

Dianette is a hormonal medication that is licensed for the treatment of severe acne that fails to respond to antibiotics and moderately severe hirsutism. Dianette also acts as a contraceptive but should not be used for this purpose alone or as a contraceptive in patients with mild acne.

Venous thromboembolism occurs more often in patients treated with dianette than those treated with low-dose combined oral contraceptives. Depression is also a known side effect of dianette.

Action: Clinicians should only prescribe dianette within the product license, review regularly and withdraw treatment upon resolution of symptoms. Repeat courses can be given if symptoms return.