December 6, 2004
by staff reporter

There is no evidence that SSRI antidepressants are likely to significantly increase suicidal behaviour, a drug watchdog has announced today.

However, the Medicines and Healthcare Products Regulatory Agency (MHRA) added that there is no additional benefit from increasing the dose of an SSRI above the recommended daily dose.

The agency's report makes a number of recommendations following its two-year investigation into the safety of the widely-prescribed selective serotonin reuptake inhibitor (SSRIs) antidepressants.

The investigation was carried out by a Committee on Safety of Medicines Expert Working Group. It analysed reported spontaneous suspected adverse drug reactions, clinical trials, published literature and epidemiological databases.

The group examined, in particular, possible suicidal behaviour and withdrawal reactions associated with SSRIs.

Thousands of patients have complained of disabling side-effects when both starting - and withdrawing from - SSRIs.

However, Professor Kent Woods, chief executive of the MHRA, said: "SSRIs are an important group of medicines, which help patients who suffer depressive illness. The benefits of SSRIs in adults are still considered to outweigh the risk of adverse drug reactions."

The CSM group has written to mental healthcare professionals, outlining its advice for when prescribing SSRIs.

The group's findings include:

* Evidence of a relationship between suicidal behaviour and increasing/decreasing dose is not robust, however patients should be monitored around the time of dose changes for any new symptoms or worsening of disease.

* There is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over.

* To minimise withdrawal reactions on stopping SSRIs, the dose should be tapered gradually over a period of several weeks, according to the patient's need.

* For the majority of SSRIs in the treatment of depression, there is no additional benefit from increasing the dose above the recommended daily dose.

* Careful and frequent patient monitoring by healthcare professionals, and where appropriate other carers, is important in the early stages of treatment.

* If a patient is not doing well after starting treatment the possibility of an adverse reaction to the drug should be considered.

The CSM group has also made separate recommendations on Efexor because of concerns about cardiotoxicity and toxicity in overdose.

Last December the MHRA effectively banned all but one SSRI, Prozac, from being prescribed to children.

In addition, concern also remains as to the reliability of the MHRA investigation into SSRIs for adults because unpublished trials of all the SSRIs on adults outnumber published results by eight to one.

Richard Brook, chief executive of mental health charity Mind, said: "This surely raises questions about their [the MHRA's] ability to get to the heart of the matter."

But the MHRA responded by saying it would not have been possible to study all original data, because of the sheer amount. "We would be looking at years," a spokeswoman told a newspaper. "It is just not feasible."

Coinciding with today's MHRA report, the National Institute for Clinical Excellence (NICE) issued guidelines on the treatment and care of people with depression and anxiety.

The guidelines - to be distributed to NHS professionals on December 15 - have advised that people with mild to moderate depression, or with moderate anxiety, may benefit more from non-drug treatments such as counseling, psychotherapy or exercise.

It also concluded that for severe depression, psychological treatment (in particular cognitive behavioural therapy) should be used in combination with antidepressants.

NICE concluded that GPs are prescribing too many antidepressants for people who do not have a serious clinical condition.

Stephen Pilling, consultant clinical psychologist and co-director of the National Collaborating Centre for Mental Health which developed the guidelines on depression said: "There is a solid base of evidence to show that psychological therapies can work as well as drug treatments for treating depression and that they have fewer side effects. The guideline reflects this fact."

* Medicines and Healthcare Products Regulatory Agency's letter on SSRIs to mental healthcare professionals (pdf)
* Medicines and Healthcare Products Regulatory Agency's questions and answers document on SSRIs (pdf)
* NICE guidelines on care and treatment of depression

See also:
Sept 21: Prozac must have suicide warning - advisers to the US Food and Drug Administration agree antidepressants can cause some young people to become suicidal.

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