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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Please ask doctors and tell them to inform their patients that following the ban on Dianette / Diane 35 in France, the European Medicines Agency is asking for submission from patients and HCPs asking if the warning about the risk of DVT is sufficient. Are doctors aware there is up to 6 times more risk and are they aware this drug is NOT licensed as a contraceptive due to added risks. Please submit evidence to ema.europa.eu asap. Too many women have died and too many are being prescribed antidepressants for depression that lifts when they stop taking Dianette. We have 150 emails and instigated the MHRA review of Dianette. Some girls have attempted suicide and know they are well again once they stop this drug. Many are on it far too long and not warned of the DVT risk according to email we receive. Some have been prescribed for over 10 years.
There is more information about psychiatric adverse drug reactions to everyday medicines and anaesthetics on the APRIL (Adverse Psychiatric Reactions Information Link) web site april.org.uk
Comment by Millie Kieve — March 8, 2013 #
@Millie,
The European Medicines Agency review is here. They are currently accepting stakeholder data submissions.
Comment by Matthew Robinson — March 8, 2013 #
I was prescribed Dianette 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 Dianette as they say the risk it too high. I found no problems with Dianette 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 #
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 #
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 #
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 #
I do hope that your daughter is recovering well.
Comment by Matthew Robinson — March 10, 2008 #