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Tuesday, 29 November 2011

MHRA - Meeting to discuss awareness and management of withdrawal reactions with SSRIs - FIDDAMAN / HEALY

Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants

26 June 2009


Professor David Healy

Mrs Sarah Morgan

Dr Julie Williams

Ms Diane Leakey

1. Introductions and background

MHRA explained that the background to this meeting was a meeting held with Mr Fiddaman in September 2008. Mr Fiddaman had raised concerns about a lack of awareness on the part of health professionals of withdrawal reactions with SSRIs and related antidepressants. Prof Healy explained that he had had a long term involvement with the safety of SSRIs and that he received a large number of e-mails directly from people withdrawing from SSRIs asking for advice on management of withdrawal symptoms. Before the meeting Prof Healy had provided documents that he had produced relating to the management of withdrawal from SSRIs.

2. Existing advice on management of withdrawal reactions with SSRIs/SNRIs

All agreed that most health professionals get their information from guidelines issued by the National Institute for Health and Clinical Excellence (NICE) and the British National Formulary (BNF) rather than directly from the Summaries of Product Characteristics (SPC), although it was noted that the SPC was very important as it dictated the information that would be available to the patient through the Patient Information Leaflet. MHRA informed Prof Healy that they had provided input to the recent consultation for revision of the NICE depression guideline and that the revised guideline would be available towards the end of the year. MHRA had also informed the BNF that they were looking at the area of withdrawal reactions and would contact them in the future regarding proposals for updates to the relevant sections of the BNF. MHRA also raised the important role played by Prescribing Advisors in the Primary Care Trusts in influencing prescribing practice. Prof Healy said that a key point not included in the guidance currently available was the existence of liquid formulations of SSRIs which could be useful in the management of withdrawal to allow slow tapering. Prof Healy also stated that before treatment started there should be a discussion between the prescriber and the patient about the possibility of withdrawal reactions.

3. Awareness of withdrawal reactions in clinical community

Prof Healy expressed the view that general practitioners (GPs) were not aware that withdrawal reactions on stopping SSRIs could be prolonged in some patients and were not aware of how to manage withdrawal reactions in these patients. Prof Healy was concerned that GPs may instinctively advise patients to withdraw by taking tablets on alternate days and this was not an appropriate approach.

4. New evidence relevant to management of withdrawal reactions

Prof Healy was not aware of any new evidence relevant to the management of withdrawal reactions. When asked if he had a view on the size of the problem of serious and prolonged withdrawal reactions with SSRIs, Prof Healy said that this was not possible to measure. Prof Healy said that while the propensity of an SSRI to cause withdrawal reactions was often thought to be only related to the half-life of the drug, this seemed unlikely to be the case – it could also be related to the potency of
the different drugs at the serotonin reuptake site. The lack of understanding of the problem contributes to a lack of effective solutions.

MHRA asked whether in his view there was any way that patients who were more at
risk of prolonged withdrawal reactions could be identified. Prof Healy said that he felt
that from his experience women seemed to be more at risk than men but it was
unknown whether this was because more women than men were treated with SSRIs.

MHRA said that their review of the issue had not identified any link between the risk
of withdrawal reactions and the gender of the patient. Prof Healy considered that
there was little evidence available on how to manage patients who had difficulty
withdrawing from SSRIs. All agreed that this was a very difficult area to study as the
management of the patient would differ depending on the patient.

5. Dependence/withdrawal for women of child-bearing years

Prof Healy had asked for the issue of use of SSRIs in pregnancy to be included in the
agenda. He said that it was an important issue and the subject of upcoming court
cases in the USA. Prof Healy said that it was important that women of childbearing
years were appropriately informed of the risk of withdrawal reactions with SSRIs
before beginning treatment and stated that in his view doctors may be liable under
the Congenital Disabilities Act 1976 if they did not adequately inform patients of the
risks of treatment during pregnancy.

MHRA said there had been communications about a small risk of congenital
malformations associated with paroxetine and this issue was under further discussion
at EU level. Prof Healy highlighted a recent publication describing an animal study
looking at reproductive toxicity of a variety of SSRIs. MHRA asked for the reference
and to be kept informed of any further new evidence of relevance to this issue.

MHRA noted that NICE had published its antenatal and postnatal mental health:
clinical management and service guidance and that it was important that NICE was
kept informed of any new evidence or advice in this area. MHRA agreed to find out
whether review of the guideline was planned and to let Prof Healy know the best
contact point for communication on this issue. Post meeting note: Prof Healy
confirmed post-meeting that he had contacted NICE on this issue.

6. Opportunities for better communication with health professionals

Prof Healy said that the focus should be on highlighting to GPs that withdrawal
reactions could be serious and prolonged in some patients and agreed that NICE and
the BNF would be reasonable routes.

7. AOB

MHRA thanked Prof Healy for attending the meeting and agreed that it would be

important to keep in contact on important new evidence in this area.


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