Royal College of Psychiatrists welcomes nice guidelines and MHRA advice on prescribing of SSRI medication in adults
By Ashwin, UK Correspondent
Dec 7, 2004, 06:04

The Royal College of Psychiatrists welcomes the much-awaited publication of the National Institute for Clinical Excellence (NICE) guidelines for Depression and Anxiety, and are pleased that the Medicines and Healthcare products Regulatory Body (MHRA) are now able to communicate its verdict on the safety of Selective Serotonin Reuptake Inhibitors (SSRIs) and newer antidepressant drugs for adults.

Large numbers of people have gained benefit from the use of SSRIs and related drugs, and for most people they appear to be free from the more serious side-effects. In recent years, there has been a great deal of uncertainty and concern amongst large groups of patients about the use of SSRIs, and clarity about the evidence for efficacy and safety has been needed.

It is essential that people with depression, their carers, and clinicians, are able to make treatment decisions on the basis of a full appraisal of all the evidence about efficacy and safety. This is a crucial step in improving confidence in clinical decision-making and the development of evidence-based guidelines.

The NICE guideline on depression, based upon the published evidence, suggests that SSRIs are effective treatments for moderate to severe depression. The guidelines developers have not, however, been able to access all unpublished trials.

The new NICE guidelines, incorporating the advice from the MHRA, now recommend greater caution in the use of SSRIs, including more intensive monitoring, especially when prescribing these and related drugs for younger adults (18 - 30 years), who may be at higher risk of developing suicidal thoughts, particularly in the first month or so of treatment.

The College welcomes the recommendation that patients will also need to know of the risks of withdrawal/discontinuation, as these may occur on stopping these drugs or when reducing the dose.

With these (and other) cautions in place, we believe that patients and clinicians will feel more confident about the safe use of these drugs.

The College considers it is very important that the MHRA has based its report upon both published and unpublished trials, and has made considerable effort to procure all the unpublished trials held by some of the pharmaceutical industry.

We therefore have some concerns that the MHRA has not been able to examine all the evidence upon which this guidance should be based, at least for some of the drugs considered.

It is also unclear whether there has been an adequate examination of the efficacy of the SSRIs and related newer drugs.

The Royal College of Psychiatrists stands by its evidence to the Parliamentary Health Select Committee last month on the role of the pharmaceutical industry, which began:

'The decision to give/receive treatment should be based upon the balance of risks and benefits. If the benefits outweigh the risks, the treatment is worth considering. If the risks outweigh the benefits, alternative treatments should be sought. To make a decision to give/receive a treatment, the doctor and patient should know about ALL the risks and potential benefits of the treatment.

Most of our knowledge about the benefit and harm associated with any drug comes from clinical research undertaken by drug companies. If pharmaceutical companies only publish clinical research that is positive, and hold back on publishing clinical research which is negative (selective reporting), then patients may well be given treatments which, unknown to either the patient or the doctor, are likely to do more harm than good.'

The Royal College of Psychiatrists is particularly pleased that the MHRA, NICE and the National Collaborating Centre for Mental Health1 will be meeting in the new year to review the current problems in accessing full safety and efficacy data, and to address the uncertainty this creates for patients, for carers, and for guideline developers.

We look forward to working with these organisations, in whatever way we can, to improve current uncertainties and to support these organisations in their efforts in strengthening confidence in the evidence base upon which clinical decisions and guidelines are currently developed.

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