SSRI guidance unchanged, says MHRA
pharmafile | March 9, 2005 | News story | Sales and Marketing |
UK regulator the MHRA has reiterated its guidance on SSRI antidepressants and stressed their safety after a new article linked them with raised suicide rates.
The BMJ published three studies on the link between the SSRI class and suicide, between them covering comparisons with placebos and tricyclics with just one concluding there was a raised number of suicide attempts in patients taking SSRIs.
Previously stung by criticism for failing to communicate on drug safety issues, the MHRA responded quickly to the publication, reassuring doctors and patients it had already reviewed the evidence.
Prof Ian Weller, Chair of the Expert Working Group which spent over a year considering all available evidence said the drugs remained safe for use in adults.
"The group conducted the largest review ever of evidence relating to SSRIs. We considered a huge range of evidence, both published and unpublished, including the studies published in the British Medical Journal this week. Whilst these studies therefore make an important contribution to the published literature on this subject, they have already been considered by the group along with all the other evidence, and they do not alter its recommendations."
The Committee on Safety of Medicine's expert working group released its long awaited guidance in December last year in tandem with the publication of depression treatment guidelines by NICE. The Working Group concluded that the SSRI class of drugs were safe for adults but singled out Wyeth's Efexor (venlafaxine) for more stringent prescribing guidelines.
NICE, incorporating advice from the MHRA, said that SSRIs were effective treatments for moderate to severe depression. More intensive monitoring was recommended for the use of the drugs, particularly in young adults who are more susceptible to a risk of suicide, especially at the start of treatment. NICE's key guidelines include:
- SSRIs should be prescribed in routine care, because they are as effective as tricyclic antidepressants and less likely to be discontinued due to side-effects.
- Antidepressants are not recommended for the initial treatment of mild depression, because of a poor risk-benefit ratio.
- Screenings should be undertaken in primary care and hospitals for depression in high-risk groups – for example those with a history of depression.
- Healthcare professionals should consider recommending a guided self-help programme based on cognitive behavioural therapy (CBT).
- The balance of risks and benefits for the treatment of depressive illness in under-18s is judged to be favourable only for Prozac (fluoxetine).
- A combination of antidepressants and individual CBT should be considered for the treatment of severe depression.
The Royal College of Psychiatrists (RCP) welcomed NICE guidelines, saying a more cautious approach would instil confidence in patients and clinicians. It also backed NICE's recommendation of advising patients on the risk of withdrawal or discontinuation of the drugs.
But, like the BMJ, it had concerns regarding the MHRA's advice, particularly the lack of clarity as to whether it had undertaken "an adequate examination" of the efficacy of SSRIs.
A RCP spokesman said: "We 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."
Meanwhile, the new guidelines have meant an added inconvenience for Efexor prescribers and its patients. Dr Trevor Jones, a consultant psychiatrist in East London, was one of a number of psychiatrists who complained that the guidelines regarding Efexor were unjustified.
"I don't think it is warranted. Patients who are prescribed Efexor now have to undertake an Electrocardiogram (ECG), which from a clinical point of view adds on a long time to what amounts to a drug with a small clinical risk. It also adds to patient anxiety and the effect of previous medication that has had to undertake an ECG is that it would get used less. Although these guidelines were what I expected, they are not clinically orientated," he said.
Consultant psychiatrist Nick Kosky, North Dorset PCT, agreed, saying ECGs were an inconvenience for healthcare practitioners and that the clinical trial data did not warrant Efexor being singled out.
Tuesday , December 07, 2004