MHRA issues new advice on SSRI dose changes, withdrawal and the risk of suicidal behaviour
New advice to patients and doctors about selective serotonin reuptake inhibitors has been issued this week by the Medicines and Healthcare products Regulatory Agency. The National Institute for Clinical Excellence has also published new guidelines for the treatment of depression and anxiety.
The MHRA has concluded that the balance of risks and benefits of all
SSRIs, in their licensed indications in adults, remains positive, but
that clear advice needs to be given with regard to withdrawal reactions,
dose changes and suicidal behaviour. It recommends that in most cases
the lowest effective dose of any SSRI should be prescribed and that there
should be careful monitoring of changes in symptoms when starting and
changing treatment. It also advises strengthened warnings about the risk
of withdrawal reactions and clearer advice on the risk of suicidal behaviour.
The report emphasises that, although a modest increase in the risk of
suicidal thoughts compared with placebo cannot be ruled out, there is
good evidence that there is no clear increase in the risk of suicide
compared to other antidepressants. However, 18–30-year-olds should
be closely monitored and assessed separately in further research, because
of their increased background risk of suicidal behaviours.
The report also recommends that treatment with venlafaxine (Efexor) should
only be initiated by specialists. Wyeth Pharmaceuticals, which markets
Efexor in the UK, has said it will challenge the MHRA action.
David Pruce, director of practice and quality improvement at the Royal
Pharmaceutical Society, commented: “Pharmacists are likely to receive
queries from patients who have read about this in the media and may be
concerned. It is important to reassure patients that no one needs to
stop treatment as a result of this new advice. If after reading the details
of the advice anyone is concerned they should contact their doctor to
discuss their treatment.”
He added: “Concerns have been expressed over the length of time
that it has taken for the MHRA to formulate this advice. While accepting
that it was important to assess all the available evidence before publishing
advice, we share these concerns. We urge the MHRA to review its processes
to see whether they could be improved.”
The new NICE guidance
on anxiety and depression takes account of the
MHRA advice and has been designed to help health professionals implement
it. The guideline recommends that, for anxiety, patients should be offered
(in order of effectiveness) psychological therapy, an SSRI or self-help,
and that decision-making should be shared by the patient and health care
professionals. For depression, the guideline recommends that antidepressants
should not be used for the initial treatment of mild depression, because
the risk–benefit ratio is poor and psychological treatments can
be as effective. When an antidepressant is prescribed, it should be an
SSRI rather than a tricyclic, because SSRIs are less likely to have to
be discontinued because of side effects. |
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