Adverse drug reactions (ADRs) caused by everyday medicines or anaesthetics can include depression, anxiety, insomnia, suicidal thoughts and actions and dependence.
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Acne drug Dianette (Diane-35) obtains new depression and suicide risk warning
Foreword to readers:
Thanks to women who
contacted APRIL and those who have heeded our request to report side-effects
for Dianette (Diane-35).
It is due to the efforts of
for many years requesting the Medicines & Healthcare Products Regulatory
Agency to review the emails
we received from women, with detailed explanations of the way Dianette affected
them, that eventually the MHRA reviewed the drug for safety issues. This review,
started in 2006, led to the manufacturers adding an additional warning about
depression which previously had been listed under MILD side effects.
The MHRA requested APRIL to
urge these women to report using the Yellow Card system. Compliance with this
request has led to reports of psychiatric adverse drug reactions (ADRs) soaring
in a few years from 3% of all reports to 33% of all reports by 2011. Due to the
increased number of reports recorded on Drug Analysis Prints by the MHRA the
manufacturer has added the warning as mentioned below in this post.
Dianette, the hormonal acne treatment manufactured by the German
pharmaceutical company Bayer, has had a label change in the UK,
following a number of reports of depression and suicidal thoughts.
Patient Information Leaflets should now include this warning
in each box of Dianette:
“Post-marketing reports of severe depression (including very
rare reports of suicidal ideation or behaviour) in patients using Dianette have
been received. However, a causal relationship between clinical depression
and Dianette has not been established.”
The drug is prescribed to 62,000 British women and millions
of women worldwide each year for acne and excessive body hair (hirsutism).
Hundreds of adverse drug reactions and some fatalities have been reporting for
people taking Dianette, also known as Diane-35 and other generic names.
In the USA
the medication has not been approved
by the Food and Drug Administration (FDA), and France banned the drug
altogether in 2013**after its links to at least four French deaths from blood
clots and 125 patients suffering serious side effects. The European medicines agency released a statementreported on BBC News
(27 February 2013)
about the decision of the French medicines agency ANSM to
“ANSM considered that
Diane-35 and its generics carry a risk of thromboembolism which has been well
known for many years, while their effectiveness in treating acne was only
moderate and alternative treatments for acne are available.”
Dianette can be taken off-label as a contraceptive pill, but
is unlicensed for this purpose due to its significantly higher risk of
blood clots compared to other
pills. Professor Dominique Maraninchi, director-general of the ANSM, believes doctors are giving women the drug as a
contraceptive off-label too often, saying:
"Diane-35 is an acne treatment that
also blocks ovulation. We have several inquiries going on that show that this
non-authorised use is significant."
Between 2010 and 2013, the MHRA revealed that seven women in the United
Kingdom have died whilst taking the drug,
with 83 reports of side effects such as thrombosis and depression.
Last year, a Dutch report revealed up to 27 women, most of
whom under 30, died from blood clots believed to be caused by Dianette.
Despite being listed as a Black Triangle Drug under further review by the medicine’s regulator, Dianette and
its generic counterparts remain on license in the UK.
Earlier this year Jessica Eales, a young sailing champion,
took her life after her 17th birthday, following 4 months of using
Dianette as an acne treatment. The coroner
Graham Short could not conclude any links
between her suicide and the drug
as she had not presented any noticeable signs of depression before this. The
coroner quoted the European Medicines Agency review of Dianette in his report,
which had concluded the benefits of the drug outweigh its risks. However, the
EU report only took into account the risks in respect of thrombosis; the risk
of depression and suicidal thoughts and actions was not considered in this
Following the death of Charlotte Porter, who died of a blood clot in 2010 whilst on Dianette, an MHRA spokesman announced: ‘Dianette
is an effective medicine for treating the distressing conditions of severe acne
and excessive hair […] Despite recent developments in France, we have
no new concerns.’ German manufacturer Bayer said: ‘Bayer believes that Dianette
has a favourable benefit-risk profile when used in accordance with the label.’
Prior to the publicity
instigated by APRIL, we were told of
many instances where antidepressants were prescribed to women who complained of
depression, and left uninformed of the link or told to stop taking Dianette.
APRIL’s research on patient safety collated 102 adverse drug reaction reports
sent in by 2011 by women on their use of Dianette. Several personal accounts
document that once removing themselves from the drug, their mood clears,
following severe depression in some instances.
One patient described how “The cloud lifted when I stopped taking Dianette”.
Woman’s hour described similar stories in their programme about contraceptive pills and mood.
This change in patient information is one step forward to
informing the patient of the risks to their mental health when taking Dianette.
Once a change in a patient leaflet is made, however, the GP may not be aware of
the new information. However, we are hopeful that following this change in
labelling, there may be further consideration of Dianette’s psychiatric side
effects taken by prescribers as well as by coroners.
Crucially we urge those affected to report adverse
side-effects using the Yellow
Card reporting system in the UK. From this,
we can build a stronger and more accurate profile of this drug for both
prescribers and the prescribed to be aware of its risks.
Bond ** Edit: The ANSM's decision to suspend Dianette was overruled as the European Commission's decision to maintain marketing authorisation was implemented in all EU Member states.