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.

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5 Comments »

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  1. 16 year old daughter prescribed Dianette for acne 5 months ago. Increased risk of thrombosis compared to other hormone treatments for acne not mentioned at GP consultation. Daughter has had an acute DVT.
    Suspected cause of the DVT is dianette

    Comment by LA MacKinnon — March 6, 2008 #

  2. I do hope that your daughter is recovering well.

    Comment by Matthew Robinson — March 10, 2008 #

  3. My daughter, (age mid 20s) has severe acne on jawline which has been unresponsive to Dianette after 8 months treatment. Is it worth persevering and what other treatment options are there? She had courses of Roaccutane as a teenager and does not want to repeat.

    Comment by N Watts — September 28, 2008 #

  4. There are other treatment options such as topical benzoyl peroxide and oral and topical antibiotics.

    If Dianette isn't helping after 8 months then there are no benefits to the treatment and the risks are still present. No benefit and all risk is not a good clinical option.

    Comment by Matthew Robinson — September 28, 2008 #

  5. I was prescribed dianett for acne and remained on it for a number of years without any problems until the product licence was changed and my doctors took me off it. 6 years on i am now suffering with acne and excess hair and my GP will not re-prescribe Diannett as they say the risk it too high. I found no problems with Dianett and am in low risk group for developing any complication. I think the change in product licencing has scared some doctors off prescibing this extremely effective medication.

    Comment by Anon — July 5, 2010 #

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